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RESEARCH ADVOCACY:
 

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QOL / PRO petition to FDA QoL-FDA-petition.pdf

�PROs (Patient Reported Outcomes) are reports of the status of a patient's health condition that come directly from the patient, without interpretation of the patient's response by a clinician or anyone else. Improved reporting of PROs will enable accurate interpretation of evidence to inform patient choice, aid clinical decision making, and inform health policy.�

To endorse (add your name & zip code): http://bit.ly/2W8LhEZ

Please support if you agree and pass on to others you know and to other support groups and organizations.
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Patti Spears (Research Advocate)
 Letter of support for the continued inclusion of �gradually implement
electronic patient-reported outcomes (ePROs)� in the new OCF Model.

PRO-Letter-of-Support-CMS-120619 FINAL.pdf

In summary, I support and encourage the continued inclusion of �gradually implement
electronic patient-reported outcomes (ePROs)� in the new OCF Model. I realize change is difficult and there will be challenges.

...However, the patient should come first and implementation of ePROs in cancer clinical care would be a way to value and engage patients in their own care. Patients feel like they have lost so much of their ability to control their lives when they are diagnosed with cancer and undergo cancer treatment. Giving patients a voice during their treatment is a step in the right direction to engage patients in a positive way throughout their care.

...As mentioned previously, controlling symptoms, staying out of the hospital, relieving anxiety, enhancing patient/doctor communication, and improving survival are just a few of the potential positive outcomes from implementing ePROs in cancer clinical care.
 
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For study teams and ethics committees:

Mandatory Exploratory Biopsies: http://bit.ly/2CVikVF 

A checklist for study reviewers and the study team
By Karl Schwartz (patient advocate)

 
NEWS and REPORTS:

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-Blood: Parsaclisib, a highly selective PI3Kδ inhibitor, in patients with relapsed or refractory B-cell malignancies. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6543513/  full text

-Am J Hematol. 2019 Dec 17. doi: 10.1002/ajh.25707. [Epub ahead of print]
Outcomes of bendamustine- or cyclophosphamide-based first-line chemotherapy in older patients with indolent B-cell lymphoma.
 https://www.ncbi.nlm.nih.gov/pubmed/31849108 

-New �don�t eat me� signal may provide basis for cancer therapies https://stan.md/39reeTu  

-Dose finding studies https://youtu.be/9l6pwo-timE 


-Online Treatment Decision Tool Reveals Variances in Practice Among Experts and Oncology Health Care Providers http://bit.ly/34N98gU  

-Why 97% of Oncology Clinical Trials Fail To Receive FDA Approval http://bit.ly/2QhbeQM

*Shared Treatment Decision-Making in Lymphoma Patients, Survivors http://bit.ly/2Z9YY8X

Of the 878 lymphoma patients who were included in this analysis, 460 (52%) responded to their preferred role in treatment decision-making.

Furthermore, 448/460 (97%) patients responded that they preferred to have an active role in the treatment decision-making paradigm.

** However, 147/448 (33%) responded they did not have a role in the decision-making process.

-Comparing Polatuzumab Vedotin Given With Rituximab, Gemcitabine and Oxaliplatin to Rituximab, Gemcitabine and Oxaliplatin in Relapsed or Refractory DLBCL https://clinicaltrials.gov/ct2/show/NCT04182204

-What Else Disappears If The ACA Is Overturned? https://n.pr/2LXK7J6

-Principles of Pharmacokinetics
Mark J. Ratain, MD and William K. Plunkett, Jr, PhD. https://www.ncbi.nlm.nih.gov/books/NBK12815/


-414 Analysis of an Online Treatment Decision Tool Reveals Variances in Practice between Experts and Oncology Healthcare Providers for Newly Diagnosed Follicular Lymphoma https://ash.confex.com/ash/2019/webprogram/Paper128988.html

-Harnessing Market Disruption in the Era of CAR T: Brand Maximization
Opportunities and Challenges in DLBCL
Authors: Paul De Santis, PharmD, Samantha Kurtz,
PhD, Siddharth Subramaniam, MS, Michael Marlatt, PhD
and Mark Powzaniuk, PhD 
http://bit.ly/33QrjBG

-Quality of life after allogeneic hematopoietic cell transplantation http://bit.ly/2OI2zHE 
Snip on QOL differences within or between patients and comparison groups, equally important is the clinical significance of findings.

-Redefining Dose-Limiting Toxicity
Clinical Advances in Hematology & Oncology
February 2015, Volume 13, Issue 2
Sophie Postel-Vinay, MD, PhD, Drug Development Department, Institut Gustave Roussy, Villejuif, France http://bit.ly/2Yc9egh


-Study to Evaluate the Efficacy of Response-adapted Strategy in Follicular Lymphoma https://clinicaltrials.gov/ct2/show/NCT02063685

-Competing Interests Complicate FDA Reform
Source: Life Science Leader
https://www.lifescienceleader.com/doc/competing-interests-complicate-fda-reform-0001

-1581 Smart Start: Rituximab, Lenalidomide, and Ibrutinib Alone and in Combination with Standard Chemotherapy for Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma: Final Phase II Results https://ash.confex.com/ash/2019/webprogram/Paper128475.html


-Phase I study of oral 5-azacytidine and romidepsin in patients with PTCL http://bit.ly/2QG3nhr

-Nivolumab Combined With Brentuximab Vedotin for Relapsed/Refractory Primary Mediastinal Large B-Cell Lymphoma: Efficacy and Safety From the Phase II CheckMate 436 Study https://ascopubs.org/doi/full/10.1200/JCO.19.01492

-Polatuzumab Vedotin ( CD79b-targeted antibody-drug conjugate) in Relapsed or Refractory Diffuse Large B-Cell Lymphoma https://ascopubs.org/doi/full/10.1200/JCO.19.00172 

-Challenges conducting comparative effectiveness research: the Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE) experience http://bit.ly/2OjkZNA


-FDA Approves Zanubrutinib (btk inhibitor) for Previously Treated MCL https://www.targetedonc.com/news/fda-approves-zanubrutinib-for-previously-treated-mcl

 -Behind the Scenes of a Radical New Cancer [treatment with potential to] Cure 
I�ve now treated several patients with the new cancer gene therapy called CAR-T, but there�s still a lot to learn http://bit.ly/2OfIO91

 -4106 Peak Lymphocyte Count after CAR T Infusion Is a Clinically Accessible Test That Correlates with Clinical Response in Axicabtagene Ciloleucel Therapy for Lymphoma https://ash.confex.com/ash/2019/webprogram/Paper127094.html

-122 Evaluation of the m7-FLIPI in Patients with Follicular Lymphoma Treated within the Gallium Trial: EZH2 mutation Status May be a Predictive Marker for Differential Efficacy of Chemotherapy https://ash.confex.com/ash/2019/webprogram/Paper130208.html

-751 Minimal Residual Disease (MRD) Assessment in the ECOG1411 Randomized Phase 2 Trial of Front-Line Bendamustine-Rituximab (BR)-Based Induction Followed By Rituximab (R) � Lenalidomide (L) Consolidation for Mantle Cell Lymphoma (MCL) http://bit.ly/34Lykoe

-4305 Rapid Improvement of Patient-Reported Outcomes (QoL factors) with Venetoclax Plus Obinutuzumab in Patients with Previously Untreated CLL and Coexisting Conditions: A Prospective Analysis from the CLL14 Trial https://ash.confex.com/ash/2019/webprogram/Paper126542.html

-Direct and indirect effects of influenza vaccination http://bit.ly/2NRIg8P

-343 Two Years Rituximab Maintenance Vs. Observation after First Line Treatment with Bendamustine Plus Rituximab (B-R) in Patients with Waldenstr�m's Macroglobulinemia (MW): Results of a Prospective, Randomized, Multicenter Phase 3 Study (the StiL NHL7-2008 MAINTAIN trial) https://ash.confex.com/ash/2019/webprogram/Paper121909.html

There was no difference in OS with the median not yet reached for both R maintenance and observation.

-Sponsor announces phase 1 trial for NHL and MM with putative mechanism of action 
NKTR-255 is an activator of the interleukin-15 (IL-15) receptor, which promotes the survival & expansion of NK cells & other tumor-killing T-cells, without increasing numbers or activity of immunosuppressive cells. http://bit.ly/2NmOajp

-Can States Fill the Gap if the Federal Government Overturns 
Preexisting-Condition Protections?
October 29, 2019
- Sabrina Corlette and Emily Curran http://bit.ly/2LuX13G


-Risk of Venous Thromboembolism in Patients with Non-Hodgkin Lymphoma Surviving Blood or Marrow Transplantation http://bit.ly/2qjFVvr

-Patients with NHL who survived 2 years or longer after BMT were surveyed for long-term health outcomes, including VTE. The median follow-up was 8.1 years (interquartile range, 5.6-12.9 years). The risk of VTE in 734 patients with NHL versus 897 siblings without a history of cancer and the risk factors associated with VTE were analyzed.

-Oncology Patients Increasingly Ask About Diet: What to Say? https://www.medscape.com/viewarticle/920543

-Dear "Skeptics," Bash Homeopathy and Bigfoot Less, Mammograms and War More
A science journalist takes a skeptical look at capital-S Skepticism 
http://bit.ly/2Gzjkkm


* Deficiencies of mammography screening. https://youtu.be/bDlxFs04DCI 
Michael Baum Professor emeritus of surgery and visiting professor of medical humanities University College London. Artist, novelist, suffers from scepticaemia.

�Anecdotes tell you nothing� �To catch it early (a surrogate) means nothing.�

-High rate of durable complete remission in follicular lymphoma after CD19 CAR-T cell immunotherapy http://bit.ly/2BJdQQC

-DLBCL studies on clinicaltrials.gov http://bit.ly/2BDLtDy 
As of Oct 2019 33 of 282 studies in phase 3: http://bit.ly/2qE0umv

-Follicular lymphoma studies on clinicaltrials.gov http://bit.ly/2BCeDmA 
As of Oct 2019 16 of 176 studies in phase 3: http://bit.ly/2N6xueD

-MALT studies on clinicaltrials.gov http://bit.ly/2W90M09 
As of Oct 2019- 3 of 78 studies in phase 3: http://bit.ly/2N6uLBV

 

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* Jordan Harmon, MHA and Reshma Gupta, MD -
Addressing Patient Affordability http://bit.ly/2AHpSJG
(Financial screening for financial harm, out of pocket transparency).
 
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 Colorectal cancer screening with faecal
immunochemical testing, sigmoidoscopy
or colonoscopy: a clinical practice
guideline
https://www.bmj.com/content/bmj/367/bmj.l5515.full.pdf
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Methods for implementing patient-reported outcome (PRO) measures of symptomatic adverse events in cancer clinical trials http://bit.ly/2o9yzK5
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Experts (Cohen, Langston, Flowers) Describe Preferred Strategies for Early-Relapsing Follicular Lymphoma http://bit.ly/2n6y96x
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Oncology/Hematology > Leukemia
Ibrutinib Cardiotoxicity: Worse Than With Chemo?
High rates of adverse events with so-called targeted therapy
http://bit.ly/2mYtMdu
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Analysis of 153,115 patients with hematological malignancies from the Swedish Family-Cancer Database refines the spectrum of familial risk http://www.bloodjournal.org/content/134/12/960?sso-checked=true
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'Dealing With the Hype': Communicating and the Art of Oncology
Leonard B. Saltz, MD https://www.medscape.com/viewarticle/887649
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 J Infect Dis. 2019
Immunogenicity and Safety of an Inactivated Enterovirus 71 Vaccine Administered Simultaneously With Hepatitis B Vaccine and Group A Meningococcal Polysaccharide Vaccine: A Phase 4, Open-Label, Single-Center, Randomized, Noninferiority Trial.
http://bit.ly/2kVSf2N
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But how many people died? Health outcomes in perspective
Cleveland Clinic Journal of Medicine. 2015 March;82(3):146-150
Author(s): Vinay Prasad, MD http://bit.ly/2kVFhlH 
Are you a lumper or a splitter?
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Association of Immunoglobulin Levels, Infectious Risk, and Mortality With Rituximab and Hypogammaglobulinemia http://bit.ly/2kVOScb
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Stat Med. 1998 May 30;17(10):1103-20.
Cancer phase I clinical trials: efficient dose escalation with overdose control.
http://bit.ly/2kwgbcD
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Colin Purrington: tips developed while teaching evolutionary biology at Swarthmore College. My prior academic life was spent at Reed College, Brown University, Washington University, and the University of Chicago.

* Mosquito control tips http://bit.ly/2m25Gyc 


* 5 myths about mosquito control http://bit.ly/2kKnJsB 

* Testing VITAMIN B as a REMEDY against MOSQUITOES http://bit.ly/2kuiih7 
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mechanism, shemekanism
Use of Metformin in DLBCL, Follicular Lymphoma? http://bit.ly/2m6SxDT
 
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Pembrolizumab (anti-PD-1 immunotherapy) in Relapsed and Refractory Mycosis Fungoides and S�zary Syndrome: A Multicenter Phase II Study http://bit.ly/2m0kZHO
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Aggressive T-cell lymphomas: 2019 updates on diagnosis, risk stratification, and management http://bit.ly/2mlTCb9
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Prognostic Significance of MYC Rearrangement and Translocation Partner in Diffuse Large B-Cell Lymphoma: A Study by the Lunenburg Lymphoma Biomarker Consortium http://bit.ly/2miNZKR  #lymsm
 
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RESONATE: up to 6 years of follow-up on ibrutinib in patients with previously treated CLL or SLL. http://bit.ly/2kls59b  #lymsm

Okay but is ofatumumab the right comparator?
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ASCO 2019 Non Hodgkin Lymphoma Update : Polatuzumab Vedotin for R/R DLBCL, Chemo for Waldenstroms, Lenalidomide and Rituximab in Relapsed Indolent Lymphoma, & Induction Rituximab in iNHL http://bit.ly/2meIoFj

* Simon Rule, MD, Stephen M. Ansell, MD, PhD, and Anas Younes, MD
In this video, �New Strategies for Aggressive B-Cell Lymphomas�, Simon Rule, MD, Stephen M. Ansell, MD, PhD and Anas Younes, MD discuss current thinking and future opportunities for improving outcomes in diffuse large B-cell lymphoma (DLBCL).
http://bit.ly/2mayJzA
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Plenary Session 2.11 by Dr Vinay Prasad @VPrasadMDMPH
When RCTs are Necessary (is it a parachute difference)?
& AYA Oncology with Dr. Adam Duvall http://bit.ly/2lOdkw0
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Testing safety (by dose titration) of CDDO (synthesized triterpenoid) to Treat Solid Tumors and Lymphomas http://bit.ly/2kKKfBk
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The Synthetic Triterpenoids, CDDO and CDDO-Imidazolide, Are Potent Inducers of Heme Oxygenase-1 and Nrf2/ARE Signaling http://bit.ly/2meMyNB
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Comparing Venetoclax (bcl-2 inhibitor), given with Usual Chemotherapy to Usual Chemotherapy for Double-Hit and Double Expressing aggressive B-cell Lymphomas http://bit.ly/2mc4to1
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Rationale to test tyrosine kinase inhibition to improve anthracycline-based chemotherapy efficacy in T-cell lymphoma. http://bit.ly/2kF9e9h  #lymsm
 
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PET�Guided Treatment in Early-Stage Favorable Hodgkin Lymphoma: Final Results of the International, Randomized Phase III HD16 Trial by the German Hodgkin Study Group http://bit.ly/2m6zN7z

* Br J Haematol. 2019 Jun 20. doi: 10.1111/bjh.16070. [Epub ahead of print]
Stand-alone intrathecal central nervous system (CNS) prophylaxis provide unclear benefit in reducing CNS relapse risk in elderly DLBCL patients treated with R-CHOP and is associated increased infection-related toxicity.
http://bit.ly/2lOXbGu
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Why Oncology Needs More Common Sense and Less Cheerleading
by Bishal Gyawali http://bit.ly/2lHxIPl
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Duvelisib (IPI-145) [given until progression] with [fixed schedule] Rituximab or Bendamustine-Rituximab in Non-Hodgkin Lymphoma or CLL http://bit.ly/2m4XCg5  #lymsm
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MDS foundation: Centers of Excellence https://www.mds-foundation.org/mds-centers-of-excellence-map-new/ 
 
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Lenalidomide and Risk of Acute Myeloid Leukemia (AML) Transformation Among Myelodysplastic Syndrome (MDS) Patients http://bit.ly/2k4c47p

Conclusion: To our knowledge, this study represents the largest cohort investigated outside the context of clinical trials for the rate of AML transformation among MDS patients treated with Lenalidomide and the first to specifically examine non-del(5q) patients. Lenalidomide treatment was not associated with an increased risk of AML transformation among this large cohort of MDS patients.
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The U.S. health care system is full of monopolies http://bit.ly/2ludmch 
Even the behind-the-scenes parts of the health care industry are dominated by a small handful of companies � and critics say that drives up prices for everyone.

 
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 The FDA and Sarepta: a window into the real world of drug regulation http://bit.ly/2lx2Yk0 
 
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What Statistics Can and Can�t Tell Us About Ourselves
In the era of Big Data, we�ve come to believe that, with enough information, human behavior is predictable. But number crunching can lead us perilously wrong.
http://bit.ly/2k0xLW6
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Lancet Oncol. 2019 Aug;20(8):1160-1170.
IPH4102, a first-in-class anti-KIR3DL2 monoclonal antibody, in patients with relapsed or refractory cutaneous T-cell lymphoma: an international, first-in-human, open-label, phase 1 trial.
http://bit.ly/2lP0JIT
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Haematologica. 2019 Jun 27.
A CXCR4-targeted nanocarrier achieves highly selective tumor uptake in diffuse large B-cell lymphoma mouse models.
http://bit.ly/2kfB243
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Br J Haematol. 2019 Jul 3. doi: 10.1111/bjh.16090. [Epub ahead of print]
Risk of secondary haematological malignancies in patients with follicular lymphoma: an analysis of 1028 patients treated in the rituximab era.
http://bit.ly/2keBMXa
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Molecular tumor analysis and liquid biopsy: a feasibility investigation analyzing circulating tumor DNA in patients with central nervous system lymphomas - full text http://bit.ly/2ls5Hvd
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CD19 CAR T cells following autologous transplantation in poor-risk relapsed and refractory B-cell non-Hodgkin lymphoma chemosensitive to salvage therapy. http://bit.ly/2lQ6m9H
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Therapeutic Misconception in Research Subjects: Development and Validation of a Measure http://bit.ly/2jVUHWm
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Dispositional optimism and therapeutic expectations in early=-phase oncology trials http://bit.ly/2knJ7Dy
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Zelenetz: Andrew Zelenetz on intermittent dosing with the PI3K inhibitor ME-401 in CLL and FL https://youtu.be/PvRtTpK9q0E 

excellent discussion. Me: not sure what is the usual or competing treatments for patients receiving ME-401 in these studies? And how on-treatment QoL compare.
 
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Nowakowski: Lenalidomide Plus R-CHOP (and related questions) in Patients With Newly Diagnosed DLBCL http://bit.ly/2lWhd2d
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Expert Discusses CAR T Cells, Other Advances in Mantle Cell Lymphoma http://bit.ly/310Pi0k
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Thirty Years of Medicare: Impact on the Covered Population http://bit.ly/2ZCzf7z
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Investigator Disclosure and Advanced Cancer Patient Understanding of Informed Consent and Prognosis in Phase I Clinical Trials http://bit.ly/2PhHV3r
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Sequencing Treatment Options in Mantle Cell Lymphoma http://bit.ly/2KXVFMD
 
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A Vote Against Life Expectancy | Season 2019 Episode 08/19/2019 | The Open Mind | PBS https://to.pbs.org/2U40S8E 
 
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Vanderbilt University Center for Medicine, Health, and Society director Jonathan Metzl discusses his new book �Dying of Whiteness: How the Politics of Racial Resentment is Killing America�s Heartland."
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Gluten Does Not Induce Gastrointestinal Symptoms in Healthy Volunteers: A Double-Blind Randomized Placebo Trial http://bit.ly/30DBXet
 
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ART OF ONCOLOGY
The Oncologist�s Wager
Joseph O. Jacobson, MD, MSc
http://bit.ly/2HdUPcp
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In mice: New Drug Helps Blood Stem Cells Recover from Chemotherapy and Radiation | BioSpace http://bit.ly/2z3U9BB
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Expression of TP53 is associated with the outcome of MCL independent of MIPI and Ki-67 in trials of the European MCL Network | Blood Journal http://bit.ly/30ehCfx
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Treatment approaches for older and oldest patients with diffuse large B-cell lymphoma � Use of non-R-CHOP alternative therapies and impact of comorbidities on treatment choices and outcome: A Humedica database retrospective cohort analysis, 2007�2015 http://bit.ly/2ZemmV8
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High rate of durable complete remission in follicular lymphoma after CD19 CAR-T cell immunotherapy http://bit.ly/2N0vl5U
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D�Angelo Lovell Williams for The New York Times
Why doesn�t the US have universal health care? The answer has everything to do with race. nytimes.com
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Vitamin D supplementation, cancer death and NNT | The BMJ http://bit.ly/2ORTPRl 
�If you torture the data long enough, it will confess.� Ronald Coase.
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Frontline Therapy for Mantle Cell Lymphoma Should Be Individualized Expert Urges http://bit.ly/2YIWwck
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Harms From Uninformative Clinical Trials | Research, Methods, Statistics | JAMA | JAMA Network http://bit.ly/2Z45OPw
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NIH study revises molecular classification for most common type of lymphoma | National Institutes of Health (NIH) http://bit.ly/2YXLhZ4
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Emerging cancer trends among young adults in the USA: analysis of a population-based cancer registry Open Access Published:February 03, 2019
http://bit.ly/2YTtLoI
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Minimal residual disease (MRD) monitoring in early stage follicular lymphoma can predict prognosis and drive treatment with rituximab after radiotherapy. - PubMed - NCBI http://bit.ly/2MYoREv
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Andy Slavitt (Round 2): The 2020 Candidates� Health Care Plans (August 6, 2019) https://youtu.be/w1dJvfQQNvU
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Poster: Polatuzumab Vedotin plus Bendamustine and Rituximab or
Obinutuzumab in Relapsed/Refractory Follicular Lymphoma or Diffuse
Large B-Cell Lymphoma: Updated Results of a Phase IB/II Study
postersessiononline.eu
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Early: Near-infrared photoimmunotherapy uses an antibody�photoabsorber conjugate that binds to cancer cells. When near-infrared light is applied, the cells swell and then burst, causing the cancer cell to die. Photoimmunotherapy is in clinical trials in patients with inoperable tumors. https://youtu.be/3yuVw90AEhs
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GALLIUM Phase III Trial in Follicular Lymphoma http://bit.ly/2TghKIT
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 2.06 Heart Failure, Choosing a Specialty, & the Bayesian Approach with Dr. Frank Harrell by Plenary Session | Free Listening on SoundCloud http://bit.ly/2yHyQpz
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A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas - ClinicalTrials.gov http://bit.ly/2LZF8cN
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Yogi, don�t you know anything? Berra: No mam, I don�t even suspect anything.
Search of: CBD compared to placebo | Studies With Results | - ClinicalTrials.gov http://bit.ly/2YL5PaS
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CLL - chemotherapy-free regimens - Professor Michael Hallek - Lymphoma Hub http://bit.ly/2T0citk Thus far, it depends on the age and fitness of the patients, and for CLL the mutation profile (del(17p) or p53 mutations) can exclude use of cytotoxic therapies (chemo).
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Incidence of solid cancer in patients with follicular lymphoma. - PubMed - NCBI http://bit.ly/2Kgofao  Discussion: The incidence of solid cancer in this cohort of patients with FL was low and not greater than in the general population.
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Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-Years for 29 Cancer Groups, 1990 to 2016: A Systematic Analysis for the Global Burden of Disease Study | Oncology | JAMA Oncology | JAMA Network http://bit.ly/2YyfRIx
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PRIMA Earns 'Silver Medal' for Follicular Lymphoma | Medpage Today http://bit.ly/2MCFpSa 
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Overview of Cancer Latency Periods http://bit.ly/336fuZa 
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Distinguishing opinion from evidence in clinical care guidelines | The BMJ http://bit.ly/2LNCerx 

Using expert evidence to inform guidelines

An expert can be defined as �a person who is very knowledgeable about or skilful in a particular area.�7 In this context, this includes patients and patient representatives who may have expertise and insight through experiencing a condition or intervention, as well as health professionals with clinical experience and expertise. Experts are often needed to interpret evidence, and people sometimes consider expert opinion as evidence. For example, the Canadian Task Force on the Periodic Health Examination in 1979 included expert opinion as the lowest level of evidence.8 This categorisation can still be found in hierarchies of evidence.910 However, expert opinion is not the same as evidence.

 
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Delirium Predisposing and Triggering Factors in Nursing Home Residents: A Cohort Trial-Nested Case-Control Study - IOS Press http://bit.ly/2Yy7zUX 

Similar articles for PubMed - NCBI http://bit.ly/2GD6cKB 
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Financial Insolvency as a Risk Factor for Early Mortality Among Patients With Cancer http://bit.ly/32ZTChV 
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Cancer, bankruptcy and death: study finds a link http://bit.ly/2GzQS18 

This is why I�ve become a political activist for the regulation of the drug industry and for access to affordable healthcare insurance:

Rarely Reported Outcome: After being diagnosed and treated for breast cancer three separate times, Liza Bernstein, 51, of Los Angeles has her life, her family and friends, her hopes and dreams, her art and a renewed sense of purpose � but not much else.

The digital health consultant and patient advocate has no home, no savings, no health insurance (save Medicaid) and no credit thanks to devastating bills from 22 years of scans, surgeries, energy-sapping treatments, insurance premiums, follow-up visits, complications and breast reconstruction, which she has yet to finish due to cost.

�I�m not technically bankrupt as I didn�t file � I couldn�t afford the fees at the time � but I�ve been housesitting, pet-sitting, and couch surfing for the last few years,� she said. �I have no home. I�ve spent all my savings. I sold most of my stuff and put the rest in storage. I�ve been in extreme survival mode since 2012, when I had to leave my apartment.�

Bernstein describes her situation as �precarious� and says without the help of family and friends, she would not be here.

As jarring as it sounds, though, she may actually be one of the lucky ones.

 
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Impact of Concurrent Indolent Lymphoma on the Clinical Outcome of Newly Diagnosed Diffuse Large B-Cell Lymphoma http://bit.ly/2MrIR26 
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Sustained Progression-Free [Duration] with Rituximab Maintenance, [but no survival difference] in Patients With Follicular Lymphoma: Long-Term Results of the PRIMA Study. - PubMed - NCBI http://bit.ly/2OoA3ww 
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Under Trump, the number of uninsured Americans has gone up by 7 million - Vox http://bit.ly/310J40f 
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Antibiotics inhibit tumor and disease activity in Cutaneous T cell lymphoma. - PubMed - NCBI http://bit.ly/30Wp4f8 
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The GALLIUM Study G-Chemo vs R-Chemo in Follicular Lymphoma http://bit.ly/2YlWamV 
No survival benefit at this point. PFS described as �benefit� (in isolation) in G arm without comparison of QoL.
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Tisagenlecleucel (CAR t-cell therapy) consolidation in relapsed/refractory diffuse large B-cell lymphoma patients without measurable disease at infusion | Blood Advances http://bit.ly/2y6Hr4K 
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MEDICAID AND MORTALITY: NEW EVIDENCE FROM LINKED SURVEY AND ADMINISTRATIVE DATA http://papers.nber.org/tmp/87670-w26081.pdf 
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A new study reinforces the conclusion that autism is primarily genetic � Science-Based Medicine http://bit.ly/2SxuJFK 
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A PHASE I Study of Utomilumab (4‐1BB/CD137 agonist), Given with Rituximab in patients with CD20+ Lymphoma http://bit.ly/2Z4AXPD
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RITUXIMAB + IMMUNOTHERAPY (Utomilumab and Avelumab) IN FOLLICULAR LYMPHOMA - ClinicalTrials.gov http://bit.ly/2LxbN9p
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Studies testing Utomilumab in Lymphoma OR CLL - ClinicalTrials.gov http://bit.ly/2YiUWNw  3
==
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Early progression after Bendamustine R is associated with high risk of transformation in advanced stage follicular lymphoma. - PubMed - NCBI http://bit.ly/2LXy9A9 
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War in the Blood
An intimate, feature-length documentary (1 hr 40 min) following two patients through groundbreaking �first in-human� trials for CAR T-cell therapy, a treatment described as the beginning of the end of cancer.
https://www.youtube.com/watch?v=0Nu2qe-Gf_c
 
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Advocacy -- is the beginning of the end for evidence based standards for approvals of cancer drugs?
FDA Briefing Document
Oncologic Drugs Advisory Committee Meeting
February 26, 2019 NDA 212306 Selinexor Applicant: Karyopharm Therapeutics, Inc.
https://www.fda.gov/media/121667/download 

Related discussion:
2.01 Selinexor, ECHELON-2, Parachutes, Tumor-Treating Fields, & MedTwitter by Plenary Session | Free Listening on SoundCloud http://bit.ly/30xNXhc 
�Don�t hate the player. Hate the game.�
 
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CD19-Directed CAR T-Cells Yielded High CR Rates in Relapsed, Refractory Follicular Lymphoma http://bit.ly/32sps6y http://www.bloodjournal.org
 
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Clinical outcomes and survival of patients with hematological malignancies enrolled into Phase I clinical trials - UCL Discovery http://bit.ly/2SbvEeC

Much higher response rates compared to other types of cancer.
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Updated Clinical Data from the ME-401 (PI3K inhibitor specific for the delta isoform) Monotherapy and in Combination with Rituximab Phase 1b study in Patients with Follicular Lymphoma at the 2019 ASCO Annual Meeting https://yhoo.it/2SazEMx 

Comment: an agent to watch.

Andrew D. Zelenetz, M.D., Ph.D., Principal Investigator of the Phase 1b study and Professor of Medicine at Weill Cornell Medical College, Medical Director of Quality Informatics at Memorial Sloan Kettering Cancer Center, and Chair of the National Comprehensive Cancer Network's Non-Hodgkin Lymphoma Guideline Panel, commented: "ME-401 is a second generation PI3K inhibitor specific for the delta isoform that has excellent activity in CLL and FL. This class of drugs has been associated with immune related toxicities which are also seen with ME-401 dosed continuously. However, we explored a novel dosing strategy with intermittent drug exposure (one week on, 3 weeks off) that appears to markedly reduce toxicity and maintain efficacy. If validated, this could expand the role of PI3K in B-cell malignancies. A prospective randomized phase 2 trial is underway comparing intermittent to continuous dosing aiming to confirm these preliminary findings."
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Winning the Obamacare Suit Would Be a Disaster for Republicans [and patients]
Conservatives would rather rail at judges than come up with a viable health-care alternative. Bloomberg https://bloom.bg/2XEiSGB
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Testimony of Robert M Grant, MD, MPH
Professor University of California, San Francisco
May 16, 2019 Hearing on: �HIV Prevention Drug: Billions in Corporate Profits
After Millions in Taxpayer Investments.� http://bit.ly/32j74ND 

Question: why any price for a patented drug when taxpayers paid for the research?
 
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Advocacy - how Canada and Germany regulate drugs prices:
Patented Medicine Prices Review Board
Rules of Practice and Procedure for Hearings http://bit.ly/2GjzNIX 

What Germany can teach the U.S. about how to lower drug prices - Axios http://bit.ly/2G7bM7F
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Twitter tags to find information on different types of Cancer
Tag Ontology http://bit.ly/30oECbc 
 
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Your Work Peak Is Earlier Than You Think - The Atlantic http://bit.ly/2XvH7eV 

�Many people of achievement suffer as they age, because they lose their abilities, gained over many years of hard work. Is this suffering inescapable, like a cosmic joke on the proud? Or is there a loophole somewhere�a way around the suffering?
 
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Rituximab biosimilar RTXM83 versus reference rituximab in combination with CHOP as first-line treatment for diffuse large B-cell lymphoma: a random... - PubMed - NCBI http://bit.ly/30rx1Jb

Will prices come down now for Rituxan with this competition?
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Marijuana or Hemp: FDA Says Beware Of CBD For These Reasons​ http://bit.ly/2Xv8aC9
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What constitutes an "unmet medical need" in oncology? An empirical evaluation of author usage in the biomedical literature.
Lu E, et al. Semin Oncol. 2017. http://bit.ly/2RXV5A6 
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Advocacy:  Indications with an Unmet medical need by definition should have no standard treatment.  Thus the control arm in phase studies should be, arguably, physician choice.  Search of: physician's choice OR choice of physician - List Results - ClinicalTrials.gov http://bit.ly/2NzsmDi
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A Comparison of Elderly Patients with Aggressive Histology Lymphoma who Were Entered or Not Entered on to a Randomized Phase II Trial
Chen, Skingley & Meyer http://bit.ly/2L3NSxZ
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Advocacy - conflict of interest in medicine.
Purchasing silence | Annals of Oncology | Oxford Academic http://bit.ly/2Jl92V2
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Advocacy - Doctors Up, Patient Advocates Down: Diverging ASCO Twitter Engagement http://bit.ly/2KWkauM

Comment: I find twitter an excellent venue for engaging researchers, which is what research advocates are "paid" to do.
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Frontiers | The Minimal Residual Disease in Non-Hodgkin's Lymphomas: From the Laboratory to the Clinical Practice | Oncology http://bit.ly/2XiPaH3 
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The review I wanted to write� - Darren L Dahly - Medium http://bit.ly/2RIE1y0
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False-positive pathology: improving reproducibility with the next generation of pathologists https://go.nature.com/2Lt4TRq
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Cancer Statistics - National Cancer Institute http://bit.ly/2FJISKO
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Cancer screening in the United States, 2017: A review of current American Cancer Society guidelines and current issues in cancer screening http://bit.ly/2XJRICc 
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The role of ultrasound evaluation in the detection of early-stage epithelial ovarian cancer. - PubMed - NCBI http://bit.ly/2xxAYQd
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Health Benefits and Adverse Effects of a Gluten-Free Diet in Non�Celiac Disease Patients http://bit.ly/2XjcRnB 
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Clinical Discussion with: Martin Dreyling, MD, PhD
Department of Medicine III at the Klinikum der
Universit�t M�nchen-Grosshadern in Munich, Germany

TREATMENT OF FOLLICULAR LYMPHOMA:
Focus on Relapsed Disease and Subsequent Treatment Options http://bit.ly/2IY1XuL 
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Association of gene mutations with time to first treatment in 384 treatment naive chronic lymphocytic leukaemia patients http://bit.ly/2NnI1Wb
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Nearly a quarter of rural hospitals are on the brink of closure http://bit.ly/2xiToDP
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Stimulating T Cells Against Cancer With Agonist Immunostimulatory Monoclonal Antibodies. Biology of T Cells - - Google Books http://bit.ly/2NaMTOj
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The association between HLA and non-Hodgkin lymphoma subtypes, among a transplant-indicated population. - PubMed - NCBI http://bit.ly/2N8joNi
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Ziopharm Oncology Presents Data on Very Rapid Production of CAR T Cells (YTB323) at Keystone Symposia Emerging Cellular Therapies: T Cells and Beyond | ZIOPHARM Oncology, Inc. http://bit.ly/2J6buOT 
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ITK inhibitor: A PHASE 1/1B DOSE-ESCALATION TRIAL EVALUATING CPI-818, AN ORAL INTERLEUKIN-2-INDUCIBLE T-CELL KINASE INHIBITOR, IN PATIENTS WITH RELAPSED/REFRACTORY T‐CELL LYMPHOMA http://bit.ly/2Nh2yMi 
 
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MOR208 (tafasitamab) | MorphoSys AG http://bit.ly/2IyXeiD
Comment: an agent to watch!
 
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Roche wins speedy OK for lymphoma drug Polivy
BioPharma Dive http://bit.ly/2IUZbVL
Comment: big news - another agent to watch.

Science background In vivo effects of targeting CD79b with antibodies and antibody-drug conjugates http://mct.aacrjournals.org/content/8/10/2937.long 
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Diagnosis-to-Treatment Interval Is an Important Clinical Factor in Newly Diagnosed Diffuse Large B-Cell Lymphoma and Has Implication for Bias in Clinical Trials http://bit.ly/2xcmLHT
 
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Financial Toxicity With Bishal Gyawali by Outspoken Oncology |
Free Listening on SoundCloud http://bit.ly/2KYN0dh 

Bishal Gyawali, MD, PhD, global oncologist and policy researcher, explains to Chadi the financial toxicity faced by patients with cancer and potential strategies to mitigate it. What can be done to �avoid wisely� low-value practices?
 
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FDA approves pembrolizumab (checkpoint inhibitor) for treatment of relapsed or refractory PMBCL | FDA http://bit.ly/31IouTJ 
 
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The Arc of Therapy: From Cure to Humbling Legacy
Gene Bishop, MD1 http://bit.ly/2IkuWbH
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Informed consent for early-phase clinical trials: therapeutic misestimation, unrealistic optimism and appreciation Jodi Halpern1, David Paolo1, Andrew Huang2
http://bit.ly/2Xmd6x8
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IMPAIRED IMMUNE HEALTH IN SURVIVORS OF DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL): A LARGE POPULATION‐BASED STUDY http://bit.ly/2MINcQ3 
 
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Reporting �Basic Results� in ClinicalTrials.gov http://bit.ly/2XaOAz9 
 
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A Contrarian View of Digital Health - Quillette http://bit.ly/2F7mUkz 
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Good Luck With That':
FDA Aims to Make Sense of Medicinal Cannabis | Medpage Today http://bit.ly/2WSLek3
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HEALTH-RELATED QUALITY OF LIFE (HRQoL) IN RELAPSED/REFRACTORY (R/R) INDOLENT NHL IN THE PHASE 3 AUGMENT TRIAL OF RITUXIMAB (R) PLUS LENALIDOMIDE (R2) VERSUS R PLUS PLACEBO http://bit.ly/2IF8nxe 

Changes in other domains were observed during treatment: clinically meaningful worsening diarrhea for R-PBO, worsening fatigue, appetite loss, constipation, diarrhea, and overall health status (based on EQ-5D VAS) for R2; these scores returned to baseline levels after treatment completion. Median time to deterioration was not statistically significant between pts receiving R2 and R-PBO (P = 0.16). (is this relevant?)

HRQoL changes over time were not associated with disease histology, response status, or presence of grade 3�4 adverse events (AEs).


Conclusions: HRQoL was maintained over time in the R2 arm of the AUGMENT study and no clinically meaningful difference in HRQoL was observed between treatment arms. (Is this consistent with changes described in abstract?) AEs had little effect on HRQoL and improved after treatment was completed or stopped. Adding lenalidomide to R significantly extended PFS without compromising HRQoL. Post‐progression HRQoL was not included in the analysis. (Is this consistent with changes described in abstract?) Therefore, potential worsening of HRQoL due to disease and treatment after progression and the impact of fewer or delayed progressions with R2 were not captured.
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Immunohistochemical expression of cereblon and MUM1 as potential predictive markers of response to lenalidomide in extranodal MALT lymphoma http://bit.ly/2F2pBDO 
 
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Meta-Research: A comprehensive review of randomized clinical trials in three medical journals reveals 396 medical reversals | eLife http://bit.ly/2WBnIc1
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FDA approves Bendamustin-Rituxan with Polatuzumab Vedotin (Polivy) for 2nd or greater relapsed diffuse large B-cell lymphoma | FDA http://bit.ly/2XCd8ht 

Find trials for Polatuzumab Vedotin http://bit.ly/2KNw49c 

Polivy is an antibody that is attached to a chemotherapy drug. Polivy binds to a specific protein (called CD79b) found only on B cells (a type of white blood cell), then releases the chemotherapy drug into those cells.

Addition of Polatuzumab Vedotin to Bendamustine and Rituximab (BR) Improves Outcomes in Transplant-Ineligible Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Versus BR Alone: Results from a Randomized Phase 2 Study | Blood Journal http://bit.ly/2IxogpD 

Related Giving the Axe to R-CHOP? http://bit.ly/2wNViw1 
polatuzumab vedotin in combination with rituximab and CHP (R-CHP) versus rituximab and CHOP (R-CHOP) in previously untreated patients with diffuse large B-cell lymphoma (POLARIX)
 
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Use of Alternative Medicine for Cancer and Its Impact on Survival | JNCI: Journal of the National Cancer Institute | Oxford Academic http://bit.ly/2XHzEpm 

#CancerPatients Be wary of what you want to believe is true and lacks scientific plausibility. There is no conspiracy. Regulators, scientists, doctors get cancer too as do their loved ones. There is sometimes bias in science, but it involves testing. There's no "conspiracy."
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�Smart Start�: Final results of rituximab, lenalidomide, and ibrutinib lead in prior to combination with chemotherapy for patients with newly diagnosed DLBCL. | 2019 ASCO Abstract http://bit.ly/31pQU4r 

Very much like concept of testing sequential therapy in this way. But let's not call it "smart" until it's compared to the standard.

Should this have been an RCT from the start?
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Good Luck With That':
FDA Aims to Make Sense of Medicinal Cannabis | Medpage Today http://bit.ly/2WSLek3
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Corvus Presentation of Preclinical Data on CPI-818, a First-in-class Covalent Inhibitor of ITK Targeting T-Cell Lymphomas http://bit.ly/2K48e9U
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A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma - Full Text View - ClinicalTrials.gov http://bit.ly/2EXEiIf
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"Right To Try" Bill With Alison Bateman-House | Journal of Clinical Pathways http://bit.ly/2ESNfml
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Single Patient Expanded Access graphic outline:
https://med.nyu.edu/pophealth/sites/default/files/pophealth/SPEA_Infographic.pdf
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The list of most troubled nursing homes:The list of most troubled nursing homes:
https://www.aging.senate.gov/imo/media/doc/SFF%20List%20with%20Cover%20Letter%20051419%20-%20Casey.pdf
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 FDA Approves Lenalidomide/Rituximab for Indolent Non-Hodgkin Lymphoma http://bit.ly/2ERNbmR

"2-year OS rate 93% (95% CI, 87-96) for R2 and 87% (95% CI, 81-92) for rituximab alone. "

�Thirty-seven percent of patients in the R2 arm and 42% of patients in the placebo arm had progressed within 2 years of their last regimen.�

Progression-free survival (more accurately progression free duration) was significantly improved for lenalidomide plus rituximab versus placebo plus rituximab, with a hazard ratio of 0.46 (95% CI, 0.34 to 0.62; P < .001) and median duration of 39.4 months (95% CI, 22.9 months to not reached) versus 14.1 months (95% CI, 11.4 to 16.7 months), respectively.

Source: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma http://bit.ly/2Ox6JAv


Comments: The magnitude of the PFS ( PF duration) difference was substantial. Since comparator was Rituxan mono-therapy, this result might apply to lower risk FL (patients for whom R only is appropriate). The modest improvement in OS at 2 years 93 vs 87%) might be attributed to the imbalance in participants who had relapsed within 2 years (37 vs 42%). Duration of r2 treatment was 12 cycles - about 1 year. Unfortunately, how on-treatment QoL compares was not captured or reported. MZL subgroup results were not consistent with overall results, but the small number of MZL participants makes that result inconclusive.
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Outcomes with rituximab plus bendamustine (R-Benda), dexamethasone, rituximab, cyclophosphamide (DRC), and bortezomib, dexamethasone, rituximab (BDR) as primary therapy in Waldenstrom macroglobulinemia | 2019 ASCO Annual Meeting Abstracts http://bit.ly/2JQfUwd
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First-line therapy of T-cell lymphoma: Allogeneic or autologous transplantation for consolidation�Final results of the AATT study. | 2019 ASCO Annual Meeting Abstracts http://bit.ly/2wyW7so

Rational but sobering to consider one is better because the not-as-good option can be given next.

==
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Study of interest: Comparing Bendamustine and Rituximab (BR) Versus BR with Acalabrutinib (btk-inhibitor) in Previously Untreated Mantle Cell Lymphoma clinicaltrials.gov

Sponsor's IRB-approved background: pdf
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PD1-armored CART cells (blocking PD1-PDL1/2 interaction) induce remission in refractory diffuse large B-cell lymphoma (DLBCL) patients. | 2019 ASCO Annual Meeting Abstracts http://bit.ly/2WzuQ80
 
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Safety and preliminary efficacy in patients with relapsed/refractory mantle cell lymphoma (MCL) receiving CART 19 - lisocabtagene maraleucel (Liso-cel) in TRANSCEND NHL 001. | 2019 ASCO Annual Meeting http://bit.ly/2EIBYot 
 
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Phase 1/2 trial of cirmtuzumab (humanized mAb inhibiting ROR1) given with ibrutinib: Planned analysis of phase 1 CLL cohorts. | 2019 ASCO Annual Meeting Abstracts http://bit.ly/2Xg4HIk
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Changes in circulating tumor DNA levels associated with treatment response & PFS in relapse/refractory DLBCL. | 2019 ASCO Annual Meeting http://bit.ly/2Mdg7vn
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Results of the PI3Kδ inhibitor ME-401 alone or with rituximab in R/R follicular lymphoma http://bit.ly/2QzKwmb
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Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval | Oncology | JAMA Internal Medicine | JAMA Network http://bit.ly/2Mfaehh
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FDA's Accelerated Approvals For Cancer Drugs At Odds With Many Later Studies : Shots - Health News : NPR https://n.pr/2EGviHg
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Impact on survival of surveillance imaging after first remission in follicular lymphoma. | 2019 ASCO Annual Meeting Abstracts http://bit.ly/2YPmExK
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Short regimen of rituximab plus lenalidomide in follicular lymphoma patients in need of first-line therapy. - PubMed - NCBI http://bit.ly/2WiMixB

Comment: I don't think FL patients need more expensive choices. For sponsors wanting to meaningfully advance their product in follicular lymphoma: design comparative studies in the EFS12/24 population where there's an unmet need & outcomes are interpretable.
 
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R-CHOP preceded by blood-brain barrier permeabilization with engineered tumor necrosis factor-α in primary CNS lymphoma. - PubMed - NCBI http://bit.ly/2HCXgWs
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Excellent overview:
* Mantle cell lymphoma: 2019 update on the diagnosis, pathogenesis, prognostication, and management - Preetesh Jain Michael Wang http://bit.ly/2YOymce
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ECHELON-1 Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin�s Lymphoma
https://www.nejm.org/doi/full/10.1056/NEJMoa1708984
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2018. Brentuximab vedotin for frontline Hodgkin lymphoma.pdf - Google Drive http://bit.ly/2HSSRh3
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Environ Health. 2019; 18: 2.
The evidence of human exposure to glyphosate (roundup): a review
http://bit.ly/2VGYvaV

Comment: The evidence of weak, but company hiding preclinical science is bad.
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Is the FDA Sleeping With the Enemy? � The Health Care Blog http://bit.ly/2EszTNg 
By SAURABH JHA, MD
 
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Reaping the Bounty of Publicly Available Clinical Trial Consent Forms http://bit.ly/2VyphlN 
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Monitoring ctDNA MRD in r/r DLBCL patients following the CAR T-cell therapy axicabtagene ciloleucel: Day 28 landmark analysis. | 2019 ASCO Annual Meeting Abstracts http://bit.ly/2Ed6Tc6
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Long-term follow-up of patients with relapsed or refractory (r/r) follicular lymphoma (FL) treated with copanlisib. | 2019 ASCO Annual Meeting Abstracts http://bit.ly/2Hv2m5A

Comment: QoL data needed to assess.
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EDITORIAL| Patient need, drug development, and risk
The Lancet Oncology http://bit.ly/2YuKiQe
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AZ, Forty Seven to test triple immunotherapy combo for lymphoma - PharmaTimes http://bit.ly/2vU2Kp0
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Natural Killer Cell Levels Could Influence Immunotherapy Outcomes for Lymphoma http://bit.ly/2vUMvbh
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�Who�s going to take care of these people?� - The Washington Post https://wapo.st/2vVHi2R
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CAR-T Therapy Administration With Navneet Majhail by Outspoken Oncology | Free Listening on SoundCloud http://bit.ly/2vNPORz
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Can States Fill the Gap if the Federal Government Overturns Preexisting-Condition Protections? | Commonwealth Fund http://bit.ly/2LuX13G
 
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===
 
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Study: Microtransplantation and Checkpoint Blockade Immunotherapy for Relapsed or Refractory B Cell Lymphomas - Full Text View - ClinicalTrials.gov http://bit.ly/2VoKza0 
 
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Report: Addition of Low-Dose Decitabine to Anti-PD-1 Antibody Camrelizumab in Relapsed/Refractory Classical Hodgkin Lymphoma. http://bit.ly/2vMCDQJ 
 
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Report: Brentuximab Vedotin with Chemotherapy (A+AVD) for Stage III or IV Hodgkin�s Lymphoma http://bit.ly/2IWXFUM 
 
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Impact of fatigue on quality of life in oncology patients - ScienceDirect http://bit.ly/2WtQs2m 
 
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Excellent background: Times Not to Forget Radiotherapy When Treating Patients With Lymphoma
Charles A. Enke, MD1 http://bit.ly/2PEsLSv 
 
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Rein in the four horsemen of irreproducibility
Dorothy Bishop describes how threats to reproducibility, recognized but unaddressed for decades, might finally be brought under control. https://go.nature.com/2GHeZvm
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Re-engineered CAR-T eliminates dangerous side effect in lymphoma study - Gilead Sciences, Inc. (NASDAQ:GILD) | Seeking Alpha http://bit.ly/2VoDy8E
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Case Reports in the Age of Twitter http://bit.ly/2KQ30Q6 
by Adam S Cifua,low asterisk,'Correspondence information about the author Adam S Cifulink, Andrae L Vandrossb,, Vinay Prasadc,
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Dear "Skeptics," Bash Homeopathy and Bigfoot Less, Mammograms and War More A science journalist takes a skeptical look at capital-S Skepticism
http://bit.ly/2Gzjkkm 
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Financial Toxicity is Hurting my Cancer Patients � The Health Care Blog http://bit.ly/2Pmbspa
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Oncologists Getting 6% of Drug Price Is 'Financial Conflict' https://wb.md/2vfooDS
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QOL Compromised in Caregivers of Older Cancer Patients | Medpage Today http://bit.ly/2WTySEA 
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Pembrolizumab (immune checkpoint inhibitor) Treatment for Progressive Multifocal Leukoencephalopathy (a rare & deadly Rituxan side effect) http://bit.ly/2P3gNRP Abstract
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Vaccine [with radiotherapy) Induces Remissions in Indolent Lymphoma | Medpage Today http://bit.ly/2IawSES
(pet peeve: with a single arm study you can�t know which (vaccine or radiotherapy) caused the effect.)
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What is Driving U.S. Health Care Spending - RWJF https://rwjf.ws/2UInGxp

Health care cost growth is currently projected to return to a rapid rate of increase in the near future, as illustrated by Figure 2. The Centers for Medicare and Medicaid Services (CMS) estimate that American health spending will reach nearly $5 trillion, or 20 percent of
GDP, by 2021.14
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Obamacare fight obscures America�s real health care crisis: Money - POLITICO https://politi.co/2CXR9JB
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CBO-certified Opinion | Health Care Lying Syndrome - The New York Times https://nyti.ms/2JWdbSV
 

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Refractoriness to rituximab-based therapy and elevated serum B2-microglobulin predict for inferior survival in marginal zone lymphoma. - PubMed - NCBI http://bit.ly/2I4vR15
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Neutropenic diets to prevent cancer infections: updated systematic review and meta-analysis | BMJ Supportive & Palliative Care http://bit.ly/2YPCAkw  
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PD-L1 gene alterations identify a subset of diffuse large B-cell lymphoma harboring a T cell-inflamed phenotype. - PubMed - NCBI http://bit.ly/2VlV0Y5
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CAR-T Cell Therapy - Patient Eligibility for Clinical Trials vs. Commercial Drugs | VuMedi http://bit.ly/2Uyrn8U
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Dose-Adjusted EPOCH-R Compared With R-CHOP as Frontline Therapy for Diffuse Large B-Cell Lymphoma: Clinical Outcomes of the Phase III Intergroup Trial Alliance/CALGB 50303 http://bit.ly/2K4oJUa
 
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#FridayThoughts to test lower dose CAR t-cell consolidation following initial R-CHOP for the double hit subtype of DLBCL?
 
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Dose-Adjusted EPOCH-R Compared With R-CHOP as Frontline Therapy for Diffuse Large B-Cell Lymphoma: Clinical Outcomes of the Phase III Intergroup Trial Alliance/CALGB 50303 http://bit.ly/2K4oJUa
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Encouraging but too little information and follow up to interpret: Single Agent Umbralisib Effective for Relapsed Slow-Growing Lymphoma  http://bit.ly/2YJVRnx
 
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Probiotics, touted as good for the gut, may be trouble for immune system http://bit.ly/2YSNRke
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CAR-T Cell Therapy in Diffuse Large B Cell Lymphoma: Hype and Hope: HemaSphere http://bit.ly/2YDV9bi
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David Maloney talk: CAR-T Cell Therapy - Patient Eligibility for Clinical Trials vs. Commercial Drugs | VuMedi http://bit.ly/2Uyrn8U
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AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma http://bit.ly/2Ox6JAv

Opinion: encouraging but more time is needed to see if the substantial PFS improvement leads to living longer.  The study did not compare quality of life.
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Effectiveness in the Absence of Efficacy: Cautionary Tales From
Real-World Evidence http://bit.ly/2TZ4rQt

==
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Pharmacologic control of CAR-T cell function using dasatinib | Blood Advances http://bit.ly/2tMvcIm
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First-Line Treatment of Patients With Indolent Non-Hodgkin Lymphoma or Mantle-Cell Lymphoma With Bendamustine Plus Rituximab Versus R-CHOP or R-CVP... - PubMed - NCBI http://bit.ly/2EqZXYj
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Oncologic Drugs Advisory Committee Meeting February 26, 2019
NDA 212306 Selinexor http://bit.ly/2tSRGaV
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Power of Attorney: When Do You Need One? http://bit.ly/2tI9Fk5 
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Rethinking the patient experience with mobile technology
| BioPharma Dive http://bit.ly/2U83nps
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Allowing participants to skip questions in PROs - DOES IT MATTER? https://c-path.org/wp-content/uploads/2017/12/2017_ISPOR-EU_Poster_Allowing_Skipping_FINAL.pdf  
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Life expectancy of follicular lymphoma patients in complete response at 30 months is similar to that of the Spanish general population. - PubMed - NCBI http://bit.ly/2TfK1BI
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The response to lymphodepletion impacts PFS in aggressive non-Hodgkin lymphoma patients treated with CD19 CAR-T cells. - PubMed - NCBI http://bit.ly/2SUjnip
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Long-term Survival and Cost-effectiveness Associated With Axicabtagene Ciloleucel vs Chemotherapy for Treatment of B-Cell Lymphoma. | Allergy and Clinical Immunology | JAMA Network Open | JAMA Network http://bit.ly/2IwibwR
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Unmet need: Short Survival and Frequent Transformation in Extranodal Marginal Zone Lymphoma with Multiple Mucosal Sites Presentation. - PubMed - NCBI http://bit.ly/2NptEx4 
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The Utility of Phosphohistone H3 (PHH3) in Follicular Lymphoma Grading. - PubMed - NCBI http://bit.ly/2EugADH
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Systematic Review and Meta-Analysis of the Magnitude of Structural, Clinical, and Physician and Patient Barriers to Cancer Clinical Trial Participation | JNCI: Journal of the National Cancer Institute | Oxford Academic http://bit.ly/2Iy3zNB
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Approaches to Phase 1 Clinical Trial Design Focused on Safety, Efficiency and Selected Patient Populations: A Report from the Clinical Trial Design Task Force of the National Cancer Institute Investigational Drug Steering Committee http://bit.ly/2BWvB0u
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Health policy data:
Unauthorized Immigrants Prolong the Life of Medicare�s Trust Fund http://bit.ly/2IfNhZC
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The U.S. Health System and Immigration: An Institutional Interpretation http://bit.ly/2MX4AgD
 
Keywords: "wallet biopsy" "Hippocratic bubble." #SocialJustice
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The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study - Full Text View - ClinicalTrials.gov http://bit.ly/2SfxMk0 
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Multi-center, accelerated titration dose design study of TG-1801 (anti-CD47/anti-CD19 bispecific antibody) in B-Cell Lymphoma - ClinicalTrials.gov http://bit.ly/2R8JY5o
 
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Studies testing cerdulatinib Syk\Jak Inhibitor (PRT062070) in Lymphoma OR CLL http://bit.ly/2R60dVC
 
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Obinutuzumab (cd20 mab) + Umbralisib (PI3K delta inhibitor),
OR Obinutuzumab + Umbralisib + Lenalidomide
OR Obinutuzumab -Chemotherapy for early (within 24 month)
Relapsed or Refractory Grade I-IIIa Follicular Lymphoma http://bit.ly/2QDhPTO 
 
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A Study of Zanubrutinib (btk inhibitor - BGB-3111) Versus Ibrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia - Full Text View - ClinicalTrials.gov http://bit.ly/2Hpeet6
 
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No Benefit of Adding Rituximab to Methotrexate-Based Chemo Regimen in CNS Lymphoma | Oncology Newswatch http://bit.ly/2MeP3bG
 
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Zanubrutinib (BTK inhibitor) Granted Breakthrough Designation for Mantle Cell Lymphoma http://bit.ly/2FFGcOP 
 
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List of [64] Completed Lymphoma Phase 1 Studies since 2008
WITH Results- ClinicalTrials.gov http://bit.ly/2QS6Gia 

List of [368] Completed Lymphoma Phase 1 Studies since 2008
WITHOUT Results - ClinicalTrials.gov http://bit.ly/2CkJT9C
 
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Is Marijuana as Safe [or medically useful] as We Think? | The New Yorker http://bit.ly/2Caaypl
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Randomized clinical trials have their place, but critics argue that researchers would get better results if they also embraced other methodologies.
http://bit.ly/2QIeKSE
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Status of lymphoma phase 3, 2, 1 trials posted since 2008
Click to enlarge.
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Myths About Cancer 
and
Conspiracy to suppress cancer cures?
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Mandating biopsies, an advocate's checklist PDF
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Center update: NY:
Weill Cornell Medicine/NewYork-Presbyterian Hospital Lymphoma Program
New York, NY 10021

John Allan, MD
Richard Furman, MD
John Leonard, MD
Peter Martin, MD
Kristy Richards, PhD, MD
Lisa Roth, MD
Jia Ruan, MD, PhD
Sarah Rutherford, MD


Make an appointment: (646) 962-2064
Visit our blog: cornell-lymphoma.org 
View our open clinical trials: jcto.weill.cornell.edu

 
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Conflict of interest in academic oncology: moving beyond the blame game and forging a path forward
V Prasad & S V Rajkumar
https://go.nature.com/2GHU1hZ
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Phase Ib trial of an ibrutinib-based combination therapy in recurrent/refractory CNS lymphoma. - PubMed - NCBI http://bit.ly/2QR6Qey
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The MMR vaccine and autism: Sensation, refutation, retraction, and fraud http://bit.ly/2AbkPBk
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Ibrutinib-Associated Atrial Fibrillation | MedPage Today http://bit.ly/2BHGZey
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Testing Tenalisib (RP6530) Given With Romidepsin in Relapsed/Refractory T-cell Lymphoma - - ClinicalTrials.gov http://bit.ly/2EM0ZR5

Tenalisib (RP6530) is a next generation, oral, selective, PI3Kδ/g inhibitor with nanomolar inhibitory potency. Besides its apoptotic and anti-proliferative activity, Tenalisib modulates the tumor microenvironment resulting in reprogramming of tumor associated-macrophages (TAMs) from a protumor M2 phenotype to an antitumor M1 phenotype and a marked reduction of angiogenesis in pre-clinical models. Tenalisib has demonstrated activity in patients with relapsed/refractory lymphoid malignancies (Carmelo, ASH 2016 and Oki, ASCO 2018).
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HLA epitope mismatch in haploidentical transplantation is associated with decreased relapse and delayed engraftment | Blood Advances http://bit.ly/2EHbG6O
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Making evidence-based approaches to autism accessible http://bit.ly/2PWBei4 
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Glucarpidase (Voraxaze), a Carboxypeptidase Enzyme for Methotrexate Toxicity http://bit.ly/2QFfUD2 

Testing Voraxaze following standard of care MTX and rituximab in patients with CNS lymphoma in Patients With Central Nervous System Lymphoma - ClinicalTrials.gov http://bit.ly/2T4F0It 

Unlike other therapies used to treat MTX toxicity, glucarpidase (Voraxaze, BTG International, Inc.), also known as carboxypeptidase-G2 (CPDG2), is an enzyme that rapidly metabolizes circulating (not intracellular) MTX to two inactive metabolites: glutamate and 2,4-diamino-N-10-methylpteroic acid (DAMPA).10

Although patients have been receiving CPDG2 since 1993 through the FDA�s compassionate use criteria, glucarpidase was formally approved by the FDA in January 2012.10�12 The drug has demonstrated considerable safety and efficacy through case reports and clinical trials, and it is likely to be incorporated in future protocols for reversing toxic MTX levels (above 1 μmol/L) in adults and in pediatric patients with renal dysfunction.10

 
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HHS Secretary Azar Just Doesn't Get It | Medpage Today http://bit.ly/2GEXONc  

His solution? Patients need to pay for a larger proportion of their care -- have more "skin in the game," it's usually said -- so they will be more prudent in seeking care, and better, "price-conscious consumers."
 
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The Continuing Unethical Conduct of Underpowered Clinical Trials. | Drug Development | JAMA | JAMA Network http://bit.ly/2BwR6mv
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Lymphoma / CLL Haematology
Professional Information Site
http://bit.ly/2EzRB2X 
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Opinion | Dr. Google Is a Liar - The New York Times https://nyti.ms/2Brc467
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Phase I Study of Single-Agent Utomilumab (PF-05082566), a 4-1BB/CD137 Agonist, in Patients with Advanced Cancer | Clinical Cancer Research http://bit.ly/2Ejlrbh 

Studies testing utomilumab | lymphoma OR CLL - ClinicalTrials.gov http://bit.ly/2BbPBde
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Fraud - Taking Advantage | Playing by the Rules: Ethics at Work | PBS https://to.pbs.org/2C6IHrd 
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Medicare-for-all: The design and costs for Democratic health care plans - Vox http://bit.ly/2QwqJqW
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Healthcare insurance Plan types for your consideration http://bit.ly/2QuoOn3
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Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial. - PubMed - NCBI http://bit.ly/2GcI2sC
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Improving readability of informed consents for research at an academic medical institution http://bit.ly/2RRAe0P 
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Radioimmunotherapy (RIT) for Follicular Lymphoma achieves long term lymphoma control in first line and at relapse: 8-year follow-up data of 281 patients from the international RIT-registry pat http://bit.ly/2EqigiA
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Doubling rituximab in high-risk patients with aggressive B-cell lymphoma -results of the DENSE-R-MegaCHOEP trial. - http://bit.ly/2EmPek4 
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ASH Paper: AUGMENT: A Phase III Randomized Study of Lenalidomide Plus Rituximab (R2) Vs Rituximab/Placebo in Patients with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma http://bit.ly/2EbWWgb 
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Anas Younes: two practice-changing abstracts at ASH 2018
(CLL and PTCL) - VJHemOnc http://bit.ly/2zMW3Yi
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Why Do Patients Withhold Information? | Medpage Today http://bit.ly/2rcutPq
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ASH Paper: A Phase I Study of Molibresib (GSK525762), a Selective Bromodomain (BRD) and Extra Terminal Protein (BET) Inhibitor: Results from Part 1 of a Phase I/II Open Label Single Agent Study in Subjects with Non-Hodgkin�s Lymphoma (NHL) http://bit.ly/2P9Dxyf
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Nation�s Progress on Children�s Health Coverage Reverses Course � Center For Children and Families http://bit.ly/2QoEhnO
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Does Turmeric (Curcumin) Really Reduce Inflammation? - Consumer Reports http://bit.ly/2SgrAbY
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Nodal staging http://bit.ly/2TLOLMN 
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Definitive radiotherapy for localized follicular lymphoma staged by 18F-FDG PET-CT: a collaborative study by ILROG. - PubMed - NCBI http://bit.ly/2Rdwpmf
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ASH Paper: Eligibility for Car-T Trials: An Analysis of Selection Criteria and Survival Outcomes in Chemorefractory DLBCL http://bit.ly/2FJltLL 
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ASH Paper: Bone Marrow Biopsy Impacts Response Assessment in a Minority of Patients with Follicular Lymphoma and Diffuse Large B-Cell Lymphoma Treated with Immunochemotherapy: Results from the Randomized Phase III GALLIUM and GOYA Trials http://bit.ly/2Qm9qIk 
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Genomic alterations important for the prognosis in patients with follicular lymphoma treated on SWOG study S0016 CHOP vs. CHOP + Rituximab vs. CHOP + bexxar) - PubMed - NCBI http://bit.ly/2AghEaW
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If Your Immune System Is Compromised, Can You Get Vaccinated? � Health Essentials from Cleveland Clinic https://cle.clinic/2DX8KDI 

Q: Can Shingrix be administered to immunocompromised individuals?
Frequently Asked Questions About Shingrix http://bit.ly/2FF29PH 
 
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ASH Paper: Clinical Responses to CAR.CD30-T Cells in Patients with CD30+ Lymphomas Relapsed after Multiple Treatments Including Brentuximab Vedotin http://bit.ly/2SanOAU 

Interesting finding regarding the immune modulating effects of the combination of chemotherapy drugs (FLu and Benda) and the dose that so far are associated with better response to CART30.
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ASH Paper: The Combination of Duvelisib, a PI3K-δ,γ Inhibitor, and Romidepsin Is Highly Active in Relapsed/Refractory Peripheral T-Cell Lymphoma with Low Rates of Transaminitis: Results of Parallel Multicenter, Phase 1 Combination Studies with Expansion Cohorts http://bit.ly/2P24L9E 

Go to the chart to make heads or tails of it.
Duvelisib (D) given with
Romidepsin (R) OR given with Bortezomib (B).
DR is the clear winner to bring forward.
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Data Surrounding CAR T-Cell Therapy in NHL http://bit.ly/2FK5ygq 
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ASH Paper: Frontline Therapy with Bendamustine and Rituximab in Follicular Lymphoma: Prognosis Among Patients with Progression of Disease By 24 Months (POD24) Is Poor with Majority Having Transformed Lymphoma http://bit.ly/2R1Er1l 
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Animation: Immunology in the gut mucosa
https://go.nature.com/2QWHAzl 
==
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ASH Paper: CD47 Expression Defines the Efficacy of Rituximab in Non-Germinal Center B-Cell (non-GCB) Diffuse Large B-Cell Lymphoma (DLBCL) http://bit.ly/2PsjMXw 
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Placebo Effects in Oncology
Gisèle Chvetzoff Ian F. Tannock
JNCI: Journal of the National Cancer Institute, Volume 95, Issue 1, 1 January 2003, http://bit.ly/2AABIHT 

FDA Pushes Back on Placebo Inclusion in Some Cancer Trials - ACRP http://bit.ly/2Tfujng 
 
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Acid-Base Balance � Anatomy and Physiology http://bit.ly/2qSXZtw

"The buffer systems in the human body are extremely efficient, and different systems work at different rates. It takes only seconds for the chemical buffers in the blood to make adjustments to pH. The respiratory tract can adjust the blood pH upward in minutes by exhaling CO2 from the body. The renal system can also adjust blood pH through the excretion of hydrogen ions (H+) and the conservation of bicarbonate, but this process takes hours to days to have an effect."
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CD47 Blockade by Hu5F9-G4 and Rituximab in Non-Hodgkin's Lymphoma.http://bit.ly/2zvZgdE
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Liver Injury Caused by Drugs and Herbs - Liver and Gallbladder Disorders - Merck Manuals Consumer Version https://mrkmnls.co/2Du8ewD
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ASH abstracts
60th Annual Meeting and Exposition (December 1-4, 2018) http://bit.ly/2P5G3do
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Our Broken Healthcare System: How Scared Should We Be? | Medpage Today http://bit.ly/2DC9dem
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New Research Shows Vitamin D And Fish Oil Supplements May Not Be Worth It : Shots - Health News : NPR https://n.pr/2QFzGKV
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Gene expression profiling reveals a close relationship between follicular lymphoma grade 3A and 3B, but distinct profiles of follicular lymphoma grade 1 and 2 | Haematologica http://bit.ly/2PPSsBX
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ASH Paper: Patient Reported Financial Toxicity in Acute Leukemia http://bit.ly/2JU8ipQ
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ASH Paper: 2-Year Follow-up and High-Risk Subset Analysis of Zuma-1, the Pivotal Study of Axicabtagene Ciloleucel (Axi-Cel) in Patients with Refractory Large B Cell Lymphoma http://bit.ly/2PlNzAZ
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ASH Paper: Long Term Follow-up of a Phase 2 Study Examining Intratumoral G100 Alone and in Combination with Pembrolizumab in Patients with Follicular Lymphoma http://bit.ly/2AX9DJo
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ASH Paper: Outcomes of Follicular Lymphoma Patients Treated with Frontline Bendamustine and Rituximab: Impact of Histologic Grade and Early Progression on Overall Survival http://bit.ly/2Df2Ooq 

Results: 687 pts were included (616 G 1-2, 71 G 3A). Median age at diagnosis was 60 years (range 21-94) with 53% men. at 18 US cancer centers. This study included 101 patients who were a subgroup of a previously published cohort.

Bendamustine plus Rituximab Versus R-CHOP as First-Line Treatment for Patients with Follicular Lymphoma Grade 3A: Evidence from a Multicenter, Retrospective Study. http://bit.ly/2Imt1BE 

MATERIALS AND METHODS:

We retrospectively assessed 132 patients affected by FL grade 3A treated with either R-B or R-CHOP in the first line and evaluated outcome and toxicity according to the type of treatment. This study included 101 patients who were a subgroup of a previously published cohort.
 
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ASH Paper: Minimal Residual Disease Response at End of Induction and during Maintenance Correlates with Updated Outcome in the Phase III GALLIUM Study of Obinutuzumab- or Rituximab-Based Immunochemotherapy in Previously Untreated Follicular Lymphoma Patients http://bit.ly/2RAlW3Y #lymsm

 
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ASH Paper: Comparison of Efficacy and Safety of Biosimilar CT-P10 to Rituximab in Patients with Previously Untreated Low Tumor Burden Follicular Lymphoma (LTBFL): A Randomized Phase III Study http://bit.ly/2CY9IOo
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ASH Paper: Comparing
Venetoclax (Ven) + Rituximab (R) |
Ven + Bendamustine (B) + R Randomized |
B + R
in Patients with Relapsed/Refractory Follicular Lymphoma:
Final Analysis of Phase II CONTRALTO Study http://bit.ly/2SIxvHO 
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ASH Paper: Mosunetuzumab, a Full-Length Bispecific CD20/CD3 Antibody, Displays Clinical Activity in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (NHL): Interim Safety and Efficacy Results from a Phase 1 Study http://bit.ly/2yNOQa0
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40% of Americans believe alternative medicine can cure cancer
http://bit.ly/2qloK9u
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Diffuse large B-cell lymphoma in adults aged 75 years and older: a single institution analysis of cause-specific survival and prognostic factors http://bit.ly/2P8yDGn
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Drugmakers Funnel Millions To Lawmakers; A Few Dozen Get $100,000-Plus | Kaiser Health News http://bit.ly/2EWS00i
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Crunching Numbers: What Cancer Screening Statistics Really Tell Us http://bit.ly/2LicjIp 
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Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings | Complementary and Alternative Medicine | JAMA Network Open | JAMA Network http://bit.ly/2Su91Sl
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Has the Promise of Precision Medicine Been Oversold? - The ASCO Post http://bit.ly/2Rl81yJ
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People with preexisting conditions
It�s easy to SAY that you�re FOR protecting PEOPLE with PREEXISTING CONDITIONS.
Here�s what's needed to make it work:

-
Community rating
 (premiums based on selected plan, not your disease)

-
Everyone in 1 pool
 (spreads the risk and expense of rising healthcare costs broadly)
 (younger, fitter, and low income people also paying into the system)

-
Subsidies for lower income people
 helping people who would use the system for free on emergency basis
 (driving up costs for others) to contribute what they can

-
Essential Health Benefits covered.
 (protects against full range of essential health care needs)
 (critical for people with pre-existing conditions and the aging)
 (wise for everyone else � protects from financial ruin)

- Cap out-of-pocket expenses
-
No lifetime caps on claims
(especially important for people with chronic and serious disease)

-
Limit profits of insurance providers
 (competition on market with apples to apples plans)
 (rate increases must be justified � 80% rule)

Do the above policy features sound familiar?  
It�s the current law that GOP has been determined to repeal and sabotage   

~ Karl Schwartz, Patient advocate
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Study of interest: Comparing Bendamustine and Rituximab (BR) Alone to BR given with  Acalabrutinib (btk-inhibitor) in Patients over 65 years of age with Previously Untreated Mantle Cell Lymphoma - ClinicalTrials.gov http://bit.ly/2OBnYUw 
 
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Information about you ...  to bring to consults:

For advocates to share and patients to use - let's not wait for doctors to ask us about our QOL and key health domains: you can let them know by printing out and filling in this simple form.

PAL-QOL-over-time.pdf
 
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RELEVANCE study: questions, such as why the different time on treatment in the compared arms: R2 vs R-chemo 
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Next Steps in MCL Include Frontline Trials of BTK Inhibitors http://bit.ly/2NhYKsF
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Prospective study of brentuximab vedotin in relapsed/refractory Hodgkin lymphoma patients who are not suitable for stem cell transplant or multi-ag... - PubMed - NCBI http://bit.ly/2N6p6xO
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Early-Stage Follicular Lymphoma: What Is the Preferred Treatment Strategy? http://bit.ly/2wtf804
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In Situ Vaccination with a TLR 9 Agonist and Local Low Dose Radiation Induces Systemic... - Abstract - Europe PMC http://bit.ly/2PZiFLI
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ADME-tox issues for the elderly http://bit.ly/2MIZsj8
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Dose Finding of Small-Molecule Oncology Drugs: Optimization throughout the Development Life Cycle | Clinical Cancer Research http://bit.ly/2wuzvK3
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ADME of Biologics�What Have We Learned from Small Molecules? http://bit.ly/2NB75or 
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THE DIRT ON COMING CLEAN: THE PERVERSE EFFECTS OF DISCLOSING CONFLICTS OF INTEREST http://bit.ly/2oqBlYf 
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Is a glass of wine a day really unsafe? A new alcohol study, explained. - Vox http://bit.ly/2PjSWfT 
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Cancer patients - technical reasons why you can enjoy a desert: Understanding the processes behind the regulation of blood glucose | Clinical | Nursing Times http://bit.ly/2Mvdt3S
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Appropriately Diagnosing and Classifying MZL http://bit.ly/2wnDg4d 
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Global Patterns of Cancer Incidence and Mortality Rates and Trends | Cancer Epidemiology, Biomarkers & Prevention http://bit.ly/2LuIy2B
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Want to make better T-cell (CAR) therapies? First, figure out how they work. http://bit.ly/2MuhRQZ
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In mouse model:Natural killer cells engineered with chimeric antigen receptors demonstrated comparable efficacy as T cells but appeared less toxic, according to study results. http://bit.ly/2BwsTzZ 
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Dr. Maloney: CAR T Cell Therapy in Lymphoma - The ASCO Post http://bit.ly/2PjkBhL
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Owen O�Connor Issues in Immunotherapy - The ASCO Post http://bit.ly/2MCzPzP
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It's not just the uninsured � it's also the cost of health care - Axios http://bit.ly/2MroSSj
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Novel agents for primary central nervous system lymphoma: evidence and perspectives | Blood Journal http://bit.ly/2Po8Pm4
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Monitoring immune-checkpoint blockade: response evaluation and biomarker development
https://go.nature.com/2NMBj87

A subset of patients receiving immune-checkpoint inhibitor therapy develop unconventional response patterns (termed 'pseudoprogression'), in which tumour burden decreases after an initial increase, or during or after the appearance of new lesions
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The Health Care System Under French National Health Insurance: Lessons for Health Reform in the United States http://bit.ly/2N6MV8L 
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Health care in Germany: The German health care system - National Library of Medicine - PubMed Health http://bit.ly/2PntS7r
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Why a patient paid a $285 copay for a $40 drug | PBS NewsHour https://to.pbs.org/2vVfDjg

 
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Duvelisib, an oral dual PI3K-δ,γ inhibitor, shows clinical and pharmacodynamic activity in chronic lymphocytic leukemia and small lymphocytic lymph... - PubMed http://bit.ly/2L3ZbSc 
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Complementary Medicine, Refusal of Conventional Cancer Therapy, and Survival Among Patients With Curable Cancers | Oncology | JAMA Oncology | JAMA Network http://bit.ly/2JNe7Up 

Alternative medicine kills cancer patients, �complementary� edition � Science-Based Medicine http://bit.ly/2JPbpO3
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Combo of RT and Chemoimmunotherapy: Best for Early FL? https://wb.md/2PfXFzH
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Disparities in Follicular Lymphoma Survival Associated With Age, Insurance Status | Journal Of Clinical Pathways http://bit.ly/2MR4er1
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Non-invasive monitoring of diffuse large B-cell lymphoma by cell-free DNA high-throughput targeted sequencing: analysis of a prospective cohort https://go.nature.com/2MvIZOv
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Idelalisib has activity at clinically achievable drug concentrations in a subset of ABC and GCB diffuse large B-cell lymphoma and transformed follicular lymphoma cell lines | Cancer Research http://bit.ly/2nHxoOs
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Patients With DLBCL, FL Face Increasing Economic Burden http://bit.ly/2P9vKBo
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Dangerous Times: The FDA�s Role in
Information Production, Past and Future
Amy Kapczynski� pdf
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Explaining Odds Ratios http://bit.ly/2nvAYuX 
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Systematic review and meta-analysis of glyphosate exposure and risk of lymphohematopoietic cancers http://bit.ly/2nxJiKo 
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Cigarette smoking and lung cancer � relative risk estimates for the major histological types
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3296911/ 
 
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Mechanism by which a Low carb diet seems to boost the effectiveness of btk inhibitors https://go.nature.com/2KH4gQq
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CAR T Cells with Enhanced Sensitivity to B Cell Maturation Antigen for the Targeting of B Cell Non-Hodgkin�s Lymphoma and Multiple Myeloma http://bit.ly/2AOFDkX
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Genomics really gets personal: How exome and whole genome sequencing challenge the ethical framework of human genetics research http://bit.ly/2KBaSzB
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Screening and Laboratory Diagnosis
of Autoimmune Diseases Using Antinuclear Antibody
Immunofluorescence Assay and Specific Autoantibody Testing http://bit.ly/2JJra9
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Immune-related adverse events for anti-PD-1 and anti-PD-L1 drugs: systematic review and meta-analysis | The BMJ http://bit.ly/2LD4YPX 
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Hype, Fear of Failure Driving Immunotherapy 'Hail Mary' Treatments https://wb.md/2NPKR2w 
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A chimeric switch-receptor targeting PD1 augments the efficacy of second generation CAR T-Cells in advanced solid tumors http://bit.ly/2zxpfVn 
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Ibrutinib, First FDA-Approved Therapy for Marginal Zone Lymphoma | ESMO http://bit.ly/2maEJFe 
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Quality of life at diagnosis predicts overall survival in patients with aggressive lymphoma http://bit.ly/2L4sdlw 
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Regulatory requirements, experience and examples related to US Accelerated / EU Conditional Approval
http://cddf.org/files/2017/06/0850-Jan-Gross.pdf 
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Opinion | This Tweet Captures the State of Health Care in America Today - https://nyti.ms/2NnFveC
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Costs of relapsed diffuse large B-cell lymphoma among Medicare patients. - PubMed - NCBI http://bit.ly/2KpYIhX
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A Dose-Escalation Study of Venetoclax (ABT-199/GDC-0199) in Combination with Bendamustine and Rituximab in Patients with Relapsed or Refractory Non-Hodgkin's Lymphoma | Blood Journal http://bit.ly/2KliNVC
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Deferred treatment is a safe and viable option for selected patients with mantle cell lymphoma. - PubMed - NCBI http://bit.ly/2InYZvH
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Angioimmunoblastic T-cell lymphoma: a prognostic model from a retrospective study. - PubMed - NCBI http://bit.ly/2IkM9P2
 
prognostic factors for survival were bone marrow involvement, number of extranodal sites >1, and performance status >1. We categorized three risk groups: group 1, no adverse factor; group 2, one factor; and group 3, two or three factors. Five-year OS was 86.9% for Group 1, 46.3% for Group 2, and 16.2% for Group 3 (p < .0001).
 
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Clinical anti-lymphoma activity and toxicity of T cells expressing a novel anti-CD19 chimeric antigen receptor with fully-human variable regions. http://bit.ly/2yAREcL 
 
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Epizyme's tazemetostat shows positive effect in lymphoma study - http://bit.ly/2MdTxOy 
 
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FDA approves pembrolizumab for treatment of relapsed or refractory PMBCL http://bit.ly/2LQBNbY 
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Nordic Nanovector Announces Betalutin� has been Granted Fast Track Designation in the US for Follicular Lymphoma | Markets Insider https://read.bi/2y5tKGa 

Background from sponsor: nordicnanovector.com
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Patient Income Level and Cancer Clinical Trial Participation http://bit.ly/2xYgKSn 
 
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2018 ASCO Abstracts
Lymphoma http://bit.ly/2KCPbzy 
Follicular lymphoma http://bit.ly/2IzjIOf 
CLL http://bit.ly/2IzxeWk 
Marginal Zone (MALT / MZL) http://bit.ly/2IvGWVo 
Mantle Cell (MCL) http://bit.ly/2rRu2uO 
T-cell http://bit.ly/2wRRblK 
Hodgkin (HL) http://bit.ly/2rVLnm4
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Activity and tolerability of the first-in-class anti-CD47 anti *don�t eat me� antibody Hu5F9-G4 with rituximab tolerated in relapsed/refractory non-Hodgkin lymphoma: Initial phase 1b/2 results. | 2018 ASCO Annual Meeting Abstracts http://bit.ly/2xEVsJn

Given it's safety and early indications of efficacy, it's easy to imagine a future with 5F9 becoming part of standard therapy for FL and DLBCL
 
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R-CHOP preceded by blood-brain barrier permeabilization (BBBp) by NGR-tumor necrosis factor (NGR-hTNF) in patients with relapsed or refractory primary CNS lymphoma (rrPCNSL): First results of the �INGRID� phase II trial. | 2018 ASCO Annual Meeting Abstracts http://bit.ly/2LbFAA8 
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Molecular Monitoring With Circulating Tumor DNA and Nivolumab Maintenance  - ClinicalTrials.gov http://bit.ly/2wcXrnJ

Patients must have a tissue diagnosis of diffuse large B cell lymphoma, with a negative PET/CT scan performed within 28 days of study enrollment, with one of the following clinical features: high risk IPI, ABC-subtype DLBCL, Double hit/ triple hit DLBCL.

Patients can have any number of prior therapies and any amount of time period from the last therapy as long as they have complete response as seen in PET/CT at the time of enrolment.

 
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Medicaid Work Requirements: What�s the Point? http://bit.ly/2INh5I8
By Jeanne Lambrew, Senior Fellow
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Prognostic model for high tumor burden follicular lymphoma integrating baseline and end induction PET: a LYSA/FIL study
http://bit.ly/2HZmA6f
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Institute for Clinical and Economic Review Final Report on CAR-T Therapies Highlights Need for Systemwide Changes to Ensure Affordability and Access to Innovative, One-Time Therapies - ICER http://bit.ly/2pBC9K1 
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Brentuximab Vedotin an antibody-drug conjugate (given with chemotherapy) Approved by FDA for previously untreated Hodgkin Lymphoma http://bit.ly/2pstut7  - replacing the active but highly toxic bleomycin in the standard ABVD regimen.
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Personalized Medicine in a Phase I Clinical Trials Program: The MD Anderson Cancer Center Initiative | Clinical Cancer Research http://bit.ly/2HY1BR8
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Risk and surrogate benefit for pediatric Phase I trials in oncology: A systematic review with meta-analysis http://bit.ly/2CcSOfn
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Impact of novel therapies for mantle cell lymphoma in the real world setting: a report from the UK's Haematological Malignancy Research Network (HM... - PubMed - NCBI http://bit.ly/2tZ5zH9
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Testing PD-L1 Inhibitor Atezolizumab With or Without Low-dose, Local Radiation in Relapsed or Refractory Advanced Stage Follicular Lymphoma http://bit.ly/2FPLB3d 
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New concept:
Off-the-shelf anti-CD7 CAR T-cells for T-cell malignancies - 
www.youtube.com
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Study of Roflumilast (PDE-4 inhibitor) in Combination With Standard Chemotherapy for High-risk Diffuse Large B-cell Lymphoma - Full Text View - ClinicalTrials.gov http://bit.ly/2oZVQeR 

Background on study drug:
Phosphodiesterase 4 inhibitors have wide-ranging activity in B cell malignancies http://bit.ly/2HnFbJ7

Abstract

Phosphodiesterase 4 (PDE4) inhibition restores the suppressive effects of cyclic-AMP in lymphocytes. In this concise review, we detail how PDE4 inhibition downmodulates the B-cell receptor (BCR)-related kinases SYK and PI3K, inhibits VEGFA secretion by tumor cells, inducing cancer cell apoptosis and blocking angiogenesis in the microenvironment. We describe the successful clinical repurposing of PDE4 inhibitors in B-cell malignancies, and propose that given their antiinflammatory/immunomodulatory activity, these agents will suppress BCR signals without the toxicity associated with other targeted biological doublets.
 
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Zoledronic Acid for Prevention of Bone Loss in Patients Receiving Primary Therapy for Lymphomas: A Prospective, Randomized Controlled Phase III Trial http://bit.ly/2Fo43DP
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Serious Infections in Patients Receiving Ibrutinib for Treatment of Lymphoid Malignancies | Clinical Infectious Diseases | Oxford Academic http://bit.ly/2Fosr45
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2015 (still in effect) Strategic Priorities Lymphoma Steering Committee (LYSC) http://bit.ly/2oYCzcP  for cooperative group trials.
 
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Brentuximab vedotin prior to allogeneic stem cell transplantation in Hodgkin lymphoma: a report from the EBMT Lymphoma Working Party. - PubMed - NCBI http://bit.ly/2H0JVUQ
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A gene-expression profiling score for prediction of outcome in patients with follicular lymphoma: a retrospective training and validation analysis ... - PubMed - NCBI http://bit.ly/2tdLNYe
 
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Dr Bruce Cheson: Releasing Follicular Lymphoma From the Curse of Frankenstein - The ASCO Post http://bit.ly/2CMPzqY 
 
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Umbralisib Shows Early Promise in CLL and Lymphoma http://bit.ly/2GOQSbt 

Doctors, Revolt! - The New York Times http://nyti.ms/2F6FFWd 
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Vitamin D deficiency and supplementation in patients with aggressive B‐cell lymphomas treated with immunochemotherapy http://bit.ly/2CFfWPF
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Risk and surrogate benefit for pediatric Phase I trials in oncology: A systematic review with meta-analysis http://bit.ly/2CcSOfn
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Gastrointestinal follicular lymphoma: Current knowledge and future challenges. - Abstract - Europe PMC http://bit.ly/2oecWVP
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Full text: Gastrointestinal follicular lymphoma: using primary site as a predictor of survival http://bit.ly/2sPzeCm
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Allogeneic hematopoietic stem cell transplantation for relapsed follicular lymphoma: A combined analysis on behalf of the Lymphoma Working Party of... - PubMed - NCBI http://bit.ly/2o8MzRb
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Axi-Cel and Future of CAR T-Cell Therapy in Lymphoma
http://bit.ly/2EIBtMe
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ASH 2017: MURANO Trial: Venetoclax Found Superior to Standard Chemotherapy When Combined With Rituximab in CLL - The ASCO Post http://bit.ly/2EBdyOG
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Lymphoma highlights from ASCO annual meeting 2017. Lymphoma highlights from ASCO annual meeting 2017. Oncology videos for healthcare professionals - ecancer http://bit.ly/2EgS1ec
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ICML 2017: Phase II Trial of Tazemetostat (EZH2 inhibitor) in Relapsed or Refractory Follicular Lymphoma and DLBCL - The ASCO Post http://bit.ly/2FK0HXw 
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PI3K Inhibition With Copanlisib in Relapsed or Refractory Indolent Lymphoma (including Marginal Zone lymphoma) http://bit.ly/2F6hggE 
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ASH 2017: Targeted Antibody Mogamulizumab Superior to Vorinostat for Previously Treated CTCL in Phase III Trial - The ASCO Post http://bit.ly/2mv3NXc
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Therapeutic potential of SGN-CD19B, a PBD-based anti-CD19 drug conjugate, for treatment of B-cell malignancies http://bit.ly/2ja9h96 
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Brewing T-cell therapies for leukemia and lymphoma - VJHemOnc http://bit.ly/2ASFmNc
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Clinical equipoise and personal equipoise:
two necessary ingredients for reducing bias in manual therapy trials undefined http://bit.ly/2AHk3xS
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ASH 2017 abstract search http://bit.ly/2zcZrfr 
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ASH : Integration of Whole Exome and RNA Sequencing Identifies Neoepitope Vaccine Candidates in >90 Percent of Follicular Lymphoma Patients http://bit.ly/2zs1cW9
 
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The dual HDAC-PI3K inhibitor CUDC-907 as monotherapy and in combination with rituximab achieves responses and is tolerable in heavily pre-treated R/R DLBCL patients http://bit.ly/2yaenIN  Find trials http://1.usa.gov/20Qg4Gp

CUDC-907 is a first-in-class, oral small molecule inhibitor of both HDAC (class I and II) and PI3K (class Iα, β, and δ) enzymes, with demonstrated ....
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Maintenance Rituximab or Observation after Frontline Treatment with Bendamustine-Rituximab (BR) for Follicular Lymphoma: A Real World Analysis Across 13 US Cancer Centers http://bit.ly/2zamsQR
 
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Draft: urging PFS be discontinued and reported in its parts: An Advocate's Perspective on PFS endpoint
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Nov 2017: FDA Approves Acalabrutinib (btk inhibitor) for relapsed Mantle Cell Lymphoma http://bit.ly/2imGOM3 

At a median follow-up of 15.2 months, the ORR by independent review committee was 80% (95% CI, 72%-87%), which was comprised evenly of CR and PR rates of 40%. The median duration of response was not yet reached at the time of analysis, with responses ongoing at 20+ months. The median time to best response was 1.9 months.
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Interest, attitudes, and participation in clinical trials among lymphoma patients with online access
http://ascopubs.org/doi/abs/10.1200/jco.2009.27.15_suppl.e19514
 

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About Fully human CD19-specific chimeric antigen receptors for T-cell therapy http://bit.ly/2gTbQi5 

Trial: Testing T Cells Expressing a Fully-human AntiCD19 Chimeric Antigen Receptor for Treating B-cell Malignancies - reported to be near full accrual http://bit.ly/2xFmDzw
 
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Obinutuzumab (type 2 cd20 mab) for the First-Line Treatment of Follicular Lymphoma � NEJM http://bit.ly/2xsDBoE

New Response Evaluation Criteria for Lymphoma Clinical Trials: RECIL 2017 - The ASCO Post http://bit.ly/2yb45dm

Salk scientists find how cancer stops immune response - The San Diego Union-Tribune http://bit.ly/2xyrepx

Pembrolizumab in patients with CLL and Richter transformation or with relapsed CLL. - PubMed - NCBI http://bit.ly/2foIbwf

Whither Radioimmunotherapy: To Be or Not To Be? - PubMed - NCBI http://bit.ly/2w0XgY1

FDA approves new treatment for adults with relapsed follicular lymphoma http://bit.ly/2vXgNZr

Patient-reported outcomes: A new era in clinical research http://bit.ly/2wWI2qy

Progression-Free Survival: Meaningful or Simply Measurable?
Christopher M. Booth, Elizabeth A. Eisenhauer http://bit.ly/2gZvwQQ
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Predicting costs of stem-cell transplantation. - PubMed - NCBI http://bit.ly/2vG1ZOG
 
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Phase II RCT GA101 vs Rituximab in Untreated Low Tumor Burden
Indolent Non-Hodgkin's Lymphoma - Study Results - http://bit.ly/2gqcjHS
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Insurance denials for cancer clinical trial participation after the
Affordable Care Act mandate - Mackay - 2017 - Cancer - Wiley Online Library http://bit.ly/2wke7bB
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Maintenance Therapies in Indolent Lymphomas: should Recent Data Change the Standard of Care? http://bit.ly/2vUCPwx 
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Tissue Specimens in Clinical Trials: A Double-Edged Sword - The ASCO
Post http://bit.ly/2uMHm31
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SEER Non-Hodgkin Lymphoma - Cancer Stat Facts 1975-2014 http://bit.ly/2vI9Hel
SEER Hodgkin Lymphoma - Cancer Stat Facts - 2014 http://bit.ly/2fvgcL1
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Acalabrutinib received an FDA breakthrough designation for the treatment of Mantle Cell Lymphoma.

This designation is given when "preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development."

Here�s the (no-longer recruiting) study that�s the likely basis for the breakthrough designation:
https://clinicaltrials.gov/show/NCT02213926 

Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor | Journal of Hematology & Oncology | Full Text http://bit.ly/2vojqWv 

"Acalabrutinib (ACP-196) is a novel irreversible second-generation BTK inhibitor that was shown to be more potent and selective than ibrutinib. This review summarized the preclinical research and clinical data of acalabrutinib."

Comment: Acalabrutinib is in the same class as Ibrutinib (similar target, also an oral drug). Ibrutinib is already approved for use in MCL. So we might safely assume that the efficacy and/or safety appears to be substantially better for Acalabrutinib. However, I could not find an published reports on outcomes in the trial above - nor a statement by FDA on the basis for the decision. In any case, it's very big and good news.


Fact Sheet: FDA Breakthrough Therapies http://bit.ly/2uYNN3y 

 
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PROs in NCI clinical trials, Dr. Lori Minasian - CIRB-CPC-ePRO-2017-Lori-Minasian-MD,FACP.pdf
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Patient-Reported Outcome Alerts | Health Care Safety | The JAMA Network http://bit.ly/2f1ayQt 

The assessment of patient-reported outcomes (PROs) in clinical trials poses a number of potential problems. What happens when a patient reports a severe symptom and no one is monitoring that information; for example, when questionnaires are not reviewed until the end of a study? Do hospitals or researchers face liability if a patient reports suicidal thoughts on a questionnaire?
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Check this checkpoint inhibitor in lymphoma | Blood Journal http://bit.ly/2v3Ai5g

snip:  "The time is now ripe to devise a clinically relevant classification that would take into consideration biological features that have treatment implications. For instance, PDL-1�expressing lymphomas could be grouped together. Aside from HL and PMLBCL, this category would also include mediastinal gray zone lymphomas6 and Richter transformation of chronic lymphocytic leukemia.7 Potentially, other lymphomas could be included.

There is frequent overexpression of PD-L1 in Epstein-Barr virus as well as other virus-related lymphomas,8 which include Burkitt lymphoma, HIV-associated DLBCL, HIV-associated primary central nervous system lymphoma, Epstein-Barr virus+ posttransplant lymphoproliferative disorder, plasmablastic lymphomas, extranodal natural killer/T-cell lymphoma, angioimmunoblastic T-cell lymphoma, human herpesvirus 8-associated primary effusion lymphoma, and multicentric Castleman disease."
 
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Insurance approval rates for clinical trial participation rose under Affordable Care Act | Science News http://bit.ly/2gNJdBS
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7/14/17: Healthcare Bill -- update on BCRA by Slavitt
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Central nervous system relapse of diffuse large B-cell lymphoma in the rituximab era:
Results of the UK NCRI R-CHOP-14 versus 21 trial | Annals of Oncology | Oxford Academic http://bit.ly/2vFkhPE 

snip: Conclusion: Despite very limited use of IV MTX as prophylaxis, the incidence of CNS relapse following R-CHOP was very low (1.9%) confirming the reduced incidence in the rituximab era. The CNS-IPI identified patients at highest risk for CNS recurrence.
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JCO 2017: Lymphoma Remissions Caused by Anti-CD19 Chimeric Antigen Receptor T Cells Are Associated With High Serum Interleukin-15 Levels http://bit.ly/2ueiDH0  (full text)
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PD-1 Blockade in Mediastinal Gray-Zone Lymphoma � NEJM http://bit.ly/2sIKvjc

"The high frequency of 9p24.1 copy-number alterations across mediastinal lymphomas suggests a disease-specific, genetically determined dependence on PD-1 for survival. These cases provide early evidence for using PD-1 inhibition in relapsed or refractory mediastinal gray-zone lymphoma, which warrants further testing."
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2017, Splenic marginal zone lymphoma: from genetics to management
http://bit.ly/2tGnI8W 
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Incidence of marginal zone lymphoma in the United States, 2001�2009 with a focus on primary anatomic site
http://bit.ly/2sHpSnt 
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Bone marrow biopsies
do not impact response assessment for follicular lymphoma patients treated on clinical trials. abstract http://bit.ly/2u014Lj
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ADCT-301 � A Novel Antibody-drug Conjugate Against Lymphomas � Moves Into Phase I Clinical Trial ADC Review http://bit.ly/2sB0obj
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varlilumab
A human agonistic monoclonal antibody (MoAb) specific for CD27, with potential immunostimulating and antineoplastic activity. Upon administration of CDX-1127, this MoAb binds to CD27 and may potentiate the immune response by increasing the cytotoxic T-lymphocyte (CTL) response against CD27-expressing tumor cells. This may lead to growth inhibition of CD27-expressing tumor cells. In addition, this agent may increase the proliferation and activation of antigen-specific T lymphocytes upon co-administration of TAA-containing vaccines, such as dendritic cell vaccines. CD27, a co-stimulatory molecule and member of the tumor necrosis factor family overexpressed in certain tumor cell types, is constitutively expressed on mature T-lymphocytes, memory B cells and natural killer cells and plays an important role in NK cell mediated cytolytic activity and T and B lymphocyte proliferation and activation. Check for active clinical trials using this agent. (NCI Thesaurus)
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Ibrutinib - First Drug Approved for Marginal Zone Lymphoma http://wb.md/2u10bCf
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Background:

Immunotherapy: Using the Immune System to Treat Cancer - National Cancer Institute http://bit.ly/2tA44gT

Immune system - a video https://youtu.be/Lb-iMePZhLw

Crash course in three parts:
Immune System, part 1:
https://youtu.be/GIJK3dwCWCw 

Immune System, part 2:
https://youtu.be/2DFN4IBZ3rI

Immune System, part 3:
https://youtu.be/rd2cf5hValM
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MRD status at EOI was a sensitive marker of treatment efficacy, n the randomised GADOLIN study
http://onlinelibrary.wiley.com/doi/10.1002/hon.2438_80/full
Reminder: identifying a surrogate for benefit (viral load) fostered rapid progress against HIV.
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EZH2 alterations in follicular lymphoma: biological and clinical correlations - Europe PMC Article - full text http://bit.ly/2rP07QK
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Rituximab SC had similar efficacy and safety to the IV form
http://onlinelibrary.wiley.com/doi/10.1002/hon.2438_46/full
Grade =3 adverse events (58.3% SC; 54.3% IV)
Is safety really similar?
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Venetoclax Achieves Durable and Deep "treatment free" Remissions in CLL - The ASCO Post http://bit.ly/2tuyRcD 
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PROs: Collecting Patient-Reported Outcomes in Cancer Clinical Trials - National Cancer Institute http://bit.ly/2sIhqUs

ASCO17: Quickly reporting cancer complications (online PROs) may boost survival http://bit.ly/2rA1MLC  
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2017 ASCO Annual Meeting Abstracts http://bit.ly/2rFHX5a
Search tool
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2017: Dr. O'Brien on CLL updates at ASCO 17 https://youtu.be/OK2WMtotPws
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Survival outcomes for various treatment modalities in advanced-stage grade 3 follicular lymphoma (FL3):
A National Cancer Database (NCDB) study. | 2017 ASCO Annual Meeting Abstracts http://bit.ly/2qKJGHU
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Therapeutic CD94/NKG2A blockade improves natural killer cell dysfunction in CLL - PubMed #lymsm http://bit.ly/2pnlKqp

Studies testing Monalizumab (CD94/NKG2A checkpoint mab) for| CLL OR lymphoma http://bit.ly/2pcTCe4 

Monalizumab: anti-NKG2A mAb partnered with AstraZeneca and MedImmune | Innate Pharma http://bit.ly/2pMyom9

Monalizumab (previously IPH2201) is a checkpoint inhibitor, which is focused on re-establishing a broad anti-tumor response mediated by both NK and T cells.  Monalizumab is a first-in-class humanized IgG4 targeting NKG2A receptors expressed on tumor infiltrating cytotoxic NK and CD8 T lymphocytes.
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2017:
Targeting NK Cells for Anticancer Immunotherapy: Clinical and Preclinical Approaches. http://bit.ly/2pkoV6Y  (full text) 
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M7FLIPI: A Follicular Lymphoma Prognostic Model for the 21st Century
Ann S. LaCasce, MD, MSc  hematology.org
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Clinical Controversies of Double-Hit Lymphoma | Gotoper.com http://bit.ly/2qoLfex 
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Monalizumab (a checkpoint inhibitor):
anti-NKG2A mAb partnered with AstraZeneca and MedImmune | Innate Pharma
http://bit.ly/2pMyom9
 
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Impact of Expert Pathologic Review of Lymphoma Diagnosis:
Study of Patients From the French Lymphopath Network
full text: http://bit.ly/2oViQO7 
 
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Conflict of Interest in Medical Research, Education, and Practice - NCBI Bookshelf http://bit.ly/2pYGhlV
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What is the focus of lymphoma research in 2017?
Anas Younes
https://youtu.be/QgXcbfO_6sY 
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Production of Chimeric Antigen Receptor T cells
https://www.nature.com/nprot/posters/cart/cart_poster.pdf
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Testing Cirmtuzumab and Ibrutinib in Patients With B-Cell Lymphoma
B-cell Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Mantle Cell Lymphoma


ClinicalTrials.gov http://bit.ly/2o9dwFz 

About Cirmtuzumab
Targets ROR1 to Inhibit Ibrutinib-Resistant, Wnt5a-Induced Rac1 Activation in CLL | Blood Journal http://bit.ly/2oiiIV7
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Disparities in survival by insurance status in patients with Hodgkin lymphoma -
 Parikh - 2015 - Cancer - Wiley Online Library http://bit.ly/2k6Udsl
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Nivolumab (immune checkpoint MAb) + Brentuximab Vedotin (cd30-drug-conj)
After SCT for High-Risk Classical Hodgkin http://bit.ly/2mY9HD2
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Axicabtagene Ciloleucel (Kite CAR t-cell therapy targeting cd19)
Shows Response Rate of 76% in Aggressive Lymphoma http://bit.ly/2mEjHx2
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The number of extranodal sites assessed by PET/CT scan
predictor of CNS relapse for patients with diffuse large B-cell lymphoma: http://bit.ly/2lOsxsI
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Suboptimal dosing of rituximab in male and female patients with DLBCL. - PubMed - NCBI http://bit.ly/2kPfE34
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Clinico-biological characteristics and outcome of hepatitis C virus-positive DLBC Lymphoma http://bit.ly/2lotqXK
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CAR T-Cell Therapy KTE-C19 Appears Successful in Aggressive B-Cell Lymphoma - The ASCO Post http://bit.ly/2jLl6oJ
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Venetoclax (ABT-199) Studied in Relapsed or Refractory Non-Hodgkin Lymphoma - The ASCO Post http://bit.ly/2l4Z5Ow 
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Howard Burris, MD from Sarah Cannon, Nashville, TN discusses TGR-1202 for chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL). TGR-1202 is a PI3K delta inhibitor and Dr Burris discusses how it may be the third compound in this area that will be used in the clinic next to idelalisib and IPI-145. TGR-1202 is well tolerated and is used as a single agent and in combination. Recorded at the American Society of Oncology (ASCO) 2016 Annual Meeting held in Chicago, IL.
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Studies testing TGR-1202 (next gen PI3K delta inhibitor) for #Lymphoma or #CLL ClinicalTrials.gov http://bit.ly/2jg0Aep
Video: https://youtu.be/9By-u9FIbEM
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Dr Leonard: VIDEO: R-CHOP remains standard of care in DLBCL http://bit.ly/2hJbnd1
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KTE-C19 (anti-CD19 CAR T Cells) in Chemorefractory
Primary Mediastinal B-Cell Lymphoma & Transformed Follicular
http://bit.ly/2fDsqNk 

Ibrutinib-Lenalidomide-Rituximab in R/R Mantle Cell Lymphoma: First Results from the Nordic Group http://bit.ly/2fTTQxE 

Continued Excellent Outcomes in Previously Untreated Follicular Lymphoma Patients after Treatment with CHOP Plus Rituximab or CHOP Plus (131) Iodine-Tositumomab - Long Term Follow-up of Phase III Randomized Study SWOG S0016 http://bit.ly/2fsnuO7 

Intervention Versus Observation: What Is the Appropriate Endpoint?
Assessment of Endpoints in Patients with Advanced Stage Follicular Lymphoma Who Are Initially Observed http://bit.ly/2fGWonI 

Obinutuzumab-Based Induction and Maintenance Prolongs Progression-Free Survival (PFS) in Patients with Previously Untreated Follicular Lymphoma: Primary Results of the Randomized Phase 3 GALLIUM Study http://bit.ly/2fMEhMn 

Minimal Residual Disease in Patients with Follicular Lymphoma Treated with Obinutuzumab or Rituximab As First-Line Induction Immunochemotherapy and Maintenance in the Phase 3 GALLIUM Study http://bit.ly/2fqgRrP 

Polatuzumab Vedotin Combined with Obinutuzumab for Patients with Relapsed or Refractory Non-Hodgkin Lymphoma:
Preliminary Safety and Clinical Activity of a Phase Ib/II Study http://bit.ly/2fFG86e 

Paper: Rituximab Plus Lenalidomide Versus Rituximab Monotherapy in Untreated Follicular Lymphoma Patients in Need of Therapy. First Analysis of Survival Endpoints of the Randomized Phase-2 Trial SAKK 35/10 http://bit.ly/2eAp2UZ
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Medscape 2016
Bendamustine? Toxicity in FL Raises Eyebrows -- and Questions
http://wb.md/2hNXgEB
 
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Obinutuzumab-Based Induction and Maintenance Prolongs Progression-Free
Survival (PFS) in Patients with Previously Untreated Follicular Lymphoma: Primary
Results of the Randomized Phase 3 GALLIUM Study http://bit.ly/2fMEhMn

GAZYVA� (obinutuzumab) full prescribing document
https://www.gene.com/download/pdf/gazyva_prescribing.pdf
The GAZYVA dose for FL is 1000 mg

The Rituxan dose is 375 mg/m2
How do these compare - actual dose in average person?
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Obinutuzumab-Based Induction (given at 1000 mg) and Maintenance Prolongs Progression-Free
Survival (PFS) in Patients with Previously Untreated Follicular Lymphoma: Primary
Results of the Randomized Phase 3 GALLIUM Study http://bit.ly/2fMEhMn

Commentary search:
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Rituximab serum concentrations (given at 350 mg) during immuno-chemotherapy of follicular lymphoma
correlate with patient gender, bone marrow infiltration and clinical response http://bit.ly/2hiPiVd

The results of this pilot trial suggest that more differentiated dosing schedules based
on gender and bone marrow infiltration should be explored for rituximab therapy for lymphoma.
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*Medscape 2016
Bendamustine? Toxicity in FL Raises Eyebrows -- and Questions http://wb.md/2hNXgEB

(Important read for patients and oncologists)
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Positive Results from phase 2 study of rituximab, bendamustine and cytarabine (RBAC500)
as induction therapy in elderly patients with MCL | LymphomaHub http://bit.ly/2hCeRP2
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Results (encouraging) for phase II study of rituximab plus lenalidomide
for mucosa-associated lymphoid tissue Lymphoma (MALT)
... Europe PMC http://bit.ly/2hyuqqm 
 
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Financial Toxicity of Cancer
Challenges and Opportunities  EAB-financial toxicity-121316.pdf

Gary C. Doolittle, MD
Capitol Federal Masonic Professor of Oncology
Medical Director, Midwest Cancer Alliance
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The Open Notebook � Helen Ouyang Studies the Ethics of Compassionate Drug Use http://bit.ly/2hirxNl
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Our letter to ASCO Post: Limited Access to Radioimmunotherapy in Community Setting
May Lead to Extinction of a Unique Lymphoma Treatment http://bit.ly/2cOp48Z 
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Technical for scientists:
The current status of biomarkers for predicting toxicity - Europe PMC Article - Europe PMC http://bit.ly/2eoVOsT
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Why Care About the Caregivers? an underserved and undervalued group- The ASCO Post http://bit.ly/2eXcARd 
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Integrative systems to identify molecular targets in lymphoid malignancies http://bit.ly/2ctrDiS 
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ASH 15: Immunotherapy for Lymphoma Using T Cells Targeting Multiple Tumor Associated Antigens http://bit.ly/2ctiFSC
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Advocacy perspective: Ownership of Drugs Comes with Unique Responsibilities
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Refinement of the Lugano classification response criteria for lymphoma in era of immunomodulatory therapy http://bit.ly/2c61Koc

Posted to PAL topic: Response, Remission ... Terminology

Considering this finding as Progressing Disease (PD) could lead to patients being prematurely removed from a treatment from which they actually stand to benefit. This phenomenon has been well described with checkpoint blockade therapy in solid tumors, and anecdotally seen in lymphoma as well. To address this issue in the context of lymphoma immunomodulatory therapy, a workshop was convened to provide provisional recommendations to modify current response criteria in patients receiving these and future agents in clinical trials. The term "Indeterminate Response" (IR) was introduced in order to identify such lesions until confirmed as flare/pseudo-progression or true PD by either biopsy or subsequent imaging.
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Aug 2016: Dr. Julie, Brahmer,
Excellent presentation on Immunotherapy Biomarkers and Patient Selection -
YouTube http://bit.ly/2bMiIao  Posted to Biomarkers
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Scoop: Novartis disbands its pioneering cell and gene therapy unit � ENDPOINTS http://bit.ly/2bCDb2A

Sad.  Is this a marketing issue... like #radioimmunotherapy can CART be applied in community setting where 80% of patients are diagnosed and treated?
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Draft:  New PAL topic on mandating biopsies for research
Biopsies - perspective on mandating for research
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GADOLIN and the Perplexing Role of Obinutuzumab (cd20 antibody) in the Treatment of B-Cell Malignancies -
The ASCO Post http://bit.ly/2bzpkGW
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PAL topic updated Myths About Cancer
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Financial Toxicity and Cancer Treatment (PDQ�)�Health Professional Version -
National Cancer Institute http://bit.ly/2bxFhmW  posted to Financial Toxicity
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Poly(ADP-ribose) polymerase inhibitors combined with external beam and
radioimmunotherapy to treat aggressive lymphoma http://bit.ly/2bYNix2 

Posted to : Rationale for continued study of Radioimmunotherapy
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Testing safety of TGR-1202 (PI3K-delta Inhib) and
Ibrutinib (btk-inhib) for R&R Diffuse Large B-Cell Lymphoma http://bit.ly/2bRW6po
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PAL Topic updated: 
Encouragement for science- and evidence-based reasons to be hopeful.
 
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Cancer Vaccines: Are They the Wave of the Future? : Oncology Times http://bit.ly/2blp13O

Types of vaccines and challenges described
 
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2016 - stunning trend described, alarming
Medicare Part B Drug Reimbursement Program Distresses Pharmacy Players http://bit.ly/2aCFmpd

Medicare spent $22 billion on Part B drugs in 2015.
In 2007, the total payments were $11 billion; the average annual increase since 2007 has been 8.6%.

 
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PAL Update:
About Settings - our unique clinical circumstance
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Indolent B-cell and MCL: practical management of adverse events (AEs) -
induced by lenalidomide in monotherapy or in combination with rituximab (R2) | LymphomaHub http://bit.ly/2aj8EGA
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Dr. Vicki Morrison:
Assessment of Fitness, Function, and QOL Essential for Older Patients With CLL - The ASCO Post http://bit.ly/2aAWGpT 
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Roche - Roche provides update on phase III study of Gazyva/Gazyvaro in people with previously untreated diffuse large B-cell lymphoma http://bit.ly/2abwJAM 

CHOP-R apparently still on top for this indication.
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CHOP Chemotherapy Followed by (now extinct Bexxar)
Tositumomab and Iodine-131 Tositumomab for Previously Untreated DLBCL http://bit.ly/29RtvBs
 
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2016: Open questions in watchful waiting for follicular lymphoma - Sorigue - 2016 - BJH - http://bit.ly/29wtinq

Snip: "Admittedly, the information available (such as the intent of the treating physician) in retrospective series is often limited, but we believe that it is essential that different definitions of WW be kept in mind when comparing the results obtained in different series. At the same time, the fact that, despite different populations, no study has found an increased OS with any active treatment strategy over WW seems to make WW a very valid therapeutic option for asymptomatic patients with FL in the immunochemotherapy era."
 
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Jan 2016: Impact of the National Cancer Institute Community Cancer Centers Program on Clinical Trial
and Related Activities at a Community Cancer Center in Rural Nebraska.  http://1.usa.gov/1XtO3ke 

Although 85% of patients with cancer are diagnosed and treated in the community setting, only 3% are enrolled onto clinical trials. Lack of adequate time, infrastructure, resources, incentives, and reimbursement adversely affect clinical trial participation.
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Unmet need:
Open Studies for Richter's - ClinicalTrials.gov http://bit.ly/29AdEsg
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Continued Risk of Relapse Independent of Treatment Modality in Limited-Stage Diffuse Large B-Cell Lymphoma: Final and Long-Term Analysis of Southwest Oncology Group Study S8736 http://bit.ly/29BJaFW 

Question: Might late relapses be a second occurrence? Can original and relapse samples be evaluated to look for this?
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Dr. Zelenetz on use of Rituxan - For what indications? How much is too much?
https://youtu.be/LY9Ls64M-ak 
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study of interest - targeting a validated immune-pathway target in novel

Testing CA-170 (small molecule, Oral PD-L1, PD-L2 and VISTA Checkpoint Antagonist) for advanced cancer and #Lymphomas http://1.usa.gov/28W6he3 
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2016, June:
Adapted Treatment Guided by Interim PET-CT Scan in Advanced Hodgkin�s Lymphoma � NEJM http://bit.ly/2903YE7

The principal aim of this trial was to determine whether an interim FDG-PET scan could be used to guide the de-escalation of therapy for patients with a high probability of cure after ABVD therapy and escalation for those at higher risk for treatment failure. The intention was to reserve more intensive treatment for patients whose poor prognosis justified the added risk. The overall results of this approach appear favorable as compared with those of our previous studies that involved full-course ABVD and more consolidation radiotherapy.5,6 This trial population as a whole had a progression-free survival rate of 82.6% (83.7% among patients <60 years of age), and only 78 of the 1203 patients (6.5%) received radiotherapy, as compared with a progression-free survival rate of 75% and 80% in the two preceding trials, in which consolidation radiotherapy was given in 38% and 53% of patients, respectively. In all these studies, patients with stage II disease but systemic symptoms or other adverse features were included, because standard care is usually with a full course of chemotherapy, but it is evident that the results in this group are generally better than in patients with stage III and IV disease.
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Risk Factors and Outcomes for Patients With Follicular Lymphoma Who Had Histologic Transformation (HT) After Response to First-Line Immunochemotherapy (rituxan-chemo) in the PRIMA Trial PDF full report 

An important report with some surprising (to me) findings, such as CR response (judge by imaging) is not associated with a decreased risk of histologic transformation (HT) at recurrence, but early relapse is -- as is presentation in a new area.

The encouraging news is that this risk is low overall (among all who responded to r-chemo) at about 2% and that only 22% relapsed within 6 years (if I have it right); and that this is 1% less than incidence of HT previously reported ... perhaps an indication that Rituxan decreases the risk of HT.

Among those who relapse early (within 1 year), 36% had HT (among those who had a biopsy to determine this). Persons with HT can benefit from high dose chemo with auto transplant; but no advantage was seen for auto SCT for those with relapse to non-transformed (regular) FL. Among these persons (relapsed to regular FL), only 10% had radioimmunotherapy compared to 33% auto SCT. Will this finding lead to more RIT and less auto SCT for first relapse to regular FL?

An important take-home point is that a biopsy at relapse is highly recommended to inform next treatment on relapse of FL after first line R-chemo (immuno-chemotherapy)

KarlS

 
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URCC NCORP nationwide randomized controlled trial investigating the
effect of exercise on chemotherapy-induced peripheral neuropathy in 314 cancer patients.
2016 ASCO Annual Meeting | Abstracts | Meeting Library http://bit.ly/28J5ZS5 
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Market Forces Cited in Lymphoma Drugs� Disuse - The New York Times http://nyti.ms/1OunaeC

An effective treatment for lymphoma may vanish from the market - Yahoo Finance http://yhoo.it/1S97UOT
 
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Blood Journal | Ibrutinib enhances chimeric antigen receptor T-cell engraftment and efficacy in leukemia http://bit.ly/24QYmC7
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Blood Journal | The 2016 revision of the World Health Organization classification of lymphoid neoplasms http://bit.ly/20fQVjP
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Studies testing AGS67E (anti-cd37 antibody-drug conjugate) for lymphoma - - ClinicalTrials.gov Find Trials

A first in human report: anti-CD37 antibody-drug conjugate AGS67E in #lymphoma | 2016 ASCO http://bit.ly/25cvcQG 
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Switch-mediated activation and retargeting of CAR-T cells for B-cell malignancies -
Europe PMC Article - full text http://bit.ly/1TFgYML 

Snip:

Chimeric antigen receptor T (CAR-T) cell therapy has produced promising results in clinical trials but has been challenged by the inability to control engineered cells once infused into the patient. Here we present a generalizable method of controlling CAR-T cells using peptide-engrafted antibody-based molecular switches that act as a bridge between the target cell and CAR-T cell. We show that switches specific for CD19 govern the activity, tissue-homing, cytokine release, and phenotype of switchable CAR-T cells in a dose-titratable manner using xenograft mouse models of B-cell leukemia. We expect that this method of tuning CAR-T cell responses will provide improved safety and versatility of CAR�T-cell therapy in the clinic.
 
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Draft: What is true in clinical science?  What is true?
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Hodgkin
ABVD8 and BEACOPP4+4 resulted in similar EFS and OS in high-risk advanced-stage Hodgkin HL. http://bit.ly/1SCaAcD 
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Chemo brain article:
Study Finds No Association Between Anthracycline-Based Chemo and Cognitive Decline in Women With Breast Cancer - http://bit.ly/1rOU1Rk 
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Targeted agents for lymphoma
Testing agents targeting EZH2 for Lymphoma OR CLL - ClinicalTrials.gov http://1.usa.gov/1TphnlY 

Related article:
New investigational compound shows promise against melanoma, lymphoma http://bit.ly/24ufhgi 
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Health care reform?   See background articles and general (non-partisan) advice about how to inquire about policy proposals.
Articles on Health Care Reform in the US
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Saving Access to Zevalin in the Community Setting   Sign our Letter   

As a patient group we appreciate that  protecting your privacy is important to you: 
The names of persons endorsing our letter will be keep confidential and limited to being attached to the letter we will send to the Senate committee with oversight over the NRC.  The names will not be posted and will be deleted once the letters are sent.  We do not ask for your street address or email when showing your approval for our letter.  Guarantees of privacy, however cannot be given due to the limitations of the Internet. 
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Dual HDAC, PI3K Inhibitor (CUDC-907) Active in DLBC Lymphoma and Transformed http://bit.ly/1Vkeycp

snip: Five of 37 patients evaluable for response achieved an objective response to CUDC-907. There were two complete responses and three partial responses. According to the researchers, all five of these responses were in patients with DLBCL, three of which were in patients with transformed follicular lymphoma DLBCL. Fifty-seven percent of patients had stable disease, including patients with Hodgkin lymphoma and multiple myeloma.

PAL query:
CUDC-907 (dual inhibitor of PI3K and HDAC) Find Trials
 
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FL - circulating DNA testing for lymphoma

* Dynamic monitoring of circulating tumor DNA in non-Hodgkin lymphoma. - PubMed - NCBI http://1.usa.gov/1NfE53H abstract

We
have high hopes for this approach to monitoring -- that it can be more sensitive than imaging and less burdensome (a blood sample), and one day it can be used as a way to monitor disease status and duration of response to treatment - helping to assess and compare protocols with better accuracy.

* Related clinical trials http://1.usa.gov/1e5tulj

* Dynamic monitoring of circulating tumor DNA in non-Hodgkin lymphoma. - PubMed - NCBI http://1.usa.gov/1NfE53H abstract
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2 items for Hodgkins added to lymphomation

Balancing the Risk-Benefit Ratio in the Treatment of Patients With Advanced-Stage Hodgkin Lymphoma http://bit.ly/1qxVUAs 

"In summary, the SWOG S0816 study shows that treatment intensification with BEACOPP-e in patients with HL who are PET positive after two cycles of ABVD clearly improves PFS. This result will create new opportunities for risk-adapted treatment of patients with advanced-stage HL. Other future options in this setting include incorporating targeted drugs or checkpoint inhibitors. Smarter combinations of drugs along with PET-guided treatment will likely allow maintenance of high efficacy levels as has been observed with BEACOPP-e and improved tolerability. "

Response-Adapted Therapy for Stage III to IV Hodgkin Lymphoma Using Early Interim PET Imaging: SWOG S0816 http://bit.ly/1Se0Bqw
 full text JCO 

"Although the results of SWOG S0816 argue strongly for a response-adapted approach for advanced-stage HL using early interim FDG-PET/CT, it must be acknowledged that the outcomes are being compared with historical figures with their inherent limitations.

Longer follow-up is essential for confirming that the reported findings will stand the test of time. The results of ongoing, randomized, phase III trials testing this hypothesis are needed. Finally, some treatment failures were observed, even in PET2-negative patients, which indicates that interim PET is not a perfect test. We hope that in the future, molecular biomarker studies at initial diagnosis, or the combination of biomarkers and molecular imaging may define patients who require more intense therapy with eBEACOPP or other novel targeted drugs with greater accuracy than are achievable with current technology.20 Until that time, our results suggest that the response-adapted strategy of increasing treatment to eBEACOPP in PET2-positive patients is a reasonable option for advanced-stage HL therapy"
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Medscape 2016:
Venetoclax (abt-199) Approved in US for Certain CLL Patients http://wb.md/1qKFTIh 

Venetoclax (Venclexta, AbbVie and Genentech) is indicted for use in CLL patients with the chromosomal abnormality 17p deletion who have been treated with at least one previous therapy.

In this trial, conducted in 107 CLL patients harboring the 17p deletion, who have the worst prognoses, the new drug achieved an overall response rate of 79.4%. A year later, response was maintained in most patients (84.7%). "This is a very special population with the most dismal outcome," lead author Stephan Stilgenbauer, MD, from the University of Ulm, Germany, reported at the meeting.

Comment:  Good news!  Apparently an accelerated FDA approval (conditional) - based on a single-arm study in a population with an unmet need.
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Weill Cornell 2016:
Obinutuzumab Approved by the FDA for Combination Treatment of Patients with Follicular Lymphoma http://bit.ly/1oHqMNA 

This review describes a concern with the study design -- the control group protocol, which did not include Rituxan.
 
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Drug costs:
Medicare plan on payment for cancer drugs stirs battle - Chicago Tribune  http://trib.in/23EWmLL
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The Value of PET/CT in Detecting Bone Marrow Involvement
in Patients With Follicular Lymphoma http://1.usa.gov/1S2dw0T full text (a bit technical)
 
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Study of 3 drug combination (all from same sponsor)
For Relapsed / Refractory follicular lymphoma or DLBCL
Testing GAZYVA� (anti-cd20) with
Polatuzumab Vedotin (anti-CD79b Antibody-Drug Conjugate) with
Atezolizumab (anti-PDL1 - an immune checkpoint inhibitor)
http://1.usa.gov/1VFqAeU

Background: Safety, activity of anti-CD79B antibody�drug conjugate polatuzumab vedotin in
r/r B-cell lymphoma and CLL- The Lancet http://bit.ly/23kQSZO
 
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PAL pick - study of interest for Untreated Follicular Lymphoma, without a current need to treat
Testing Rituximab With or Without Zevalin Open  
Clicks as of 4/6/16:  New  Today: >


Related topic:  Radioimmunotherapy - a snapshot of its unique properties
advocating for routinely informing patients about this choice  PAL

Related advocacy:  Letter that you can endorse -- to educate Senators about
rule change that will limit access to radioimmunotherapy in community setting
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Pal Pick - study of interest:
Testing Sequential Intranodal Immunotherapy + Anti-PD1 (Pembrolizumab) in
Follicular Lymphoma http://1.usa.gov/22CxnbA

See also: PD-1/L immune checkpoint blockade Find trials
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Low Income Is a Barrier to Clinical Trial Enrollment,
Study Suggests - National Cancer Institute http://1.usa.gov/1RhXuwm
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Added to our Neuropathy resource:
Natural products & complementary therapies for chemo-induced peripheral neuropathy: -
Abstract - Europe PMC http://bit.ly/1UbldVg  | Full text - PDF 
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8-fold increase in required training (from 80 hours to 700) needed to authorize
the administration of Zevalin is a barrier to patient access. Print version - PDF
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Lymphomatous Meningitis in
Primary Central Nervous System Lymphoma http://wb.md/1SlZkBi
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To be added: Blood Journal 
How I treat adult T-cell leukemia/lymphoma http://bit.ly/1TD2DUv
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2013 report on RCT study of mogamulizumab (KW-0761) plus VCAP-AMP-VECP
for newly diagnosed aggressive adult ATL http://bit.ly/1p1jWU7
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Advanced Clinical Cell Processing Technologies for Adoptive Memory T Cell Therapy
(2016 AAAS February 2016)) http://bit.ly/1Kt6thv 

Media report: Memory cells enhance strategy for fighting blood cancers |
Science News http://bit.ly/1Kt6TV9 
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ENCOURAGING Report on YM155 (survivin inhibitor) plus rituximab
in relapsed aggressive B-cell lymphoma 1.usa.gov/212UvPB

See also YM155 (Survivin inhibitor)  Find Trials >
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Suggested Trial types by clinical circumstance - proposals for researchers

A | B | C | D | E | F | G | H | I | J | K | L | M | NO | P |
 Q | R | S | T | U | V | W | X | Y | Z

 
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Draft - recipe for progress - unsolicited advice from patients to the research community
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Is Shared Decision Making a Utopian Dream
or an Achievable Goal? - The Patient, Springer  - full text http://bit.ly/1PHGzDo
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Important paper:
Clinical impact of molecular features in diffuse large B-cell lymphoma and follicular lymphoma
Julia R. Pon1 and Marco A. Marra1,2

https://t.co/1vgm9l4YUE 
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PAL's Picks - of trials to consider - many new trials and queries added
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Dr. Saltz: The Value of Considering Cost, and the Cost of Not Considering Value http://bit.ly/1OqLOWz
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FACTIT.org PRO Questionnaires http://bit.ly/20IYCng
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Clinical trial reporting failures can harm research, patients bit.ly/1JKVteE
With comment by Karl Schwartz, president of PAL, included in the article
 

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Testing MDV9300 (anti-pd-1) in R/R Diffuse Large B-cell Lymphoma (DLBCL) including transformed 1.usa.gov/1JLqKy7
 

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Atezolizumab / MPDL3280A (is a pd1-antibody)
An immune checkpoint inhibitor that blocks the breaks on the immune system

Studies testing Atezolizumab - List Results - ClinicalTrials.gov Find Trials 

Testing Atezolizumab (pd-1 antibody) with Obinutuzumab (anti-cd20) with Lenalidomide in
Relapsed / Refractory Follicular Lymphoma Trial of Interest

A related article:
New on Cancer Currents: Checking in on Cancer Checkpoint Inhibitors http://1.usa.gov/1OoFtuB 


https://twitter.com/Lymphomation
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Testing JCAR017 (CART 19) in B-cell NH Lymphoma (NHL) - Biopsy-proven refractory after frontline chemo-immunotherapy http://1.usa.gov/1TScjZ9  

Relapsed or refractory B-cell NHL, including

Diffuse large B-cell lymphoma (DLBCL) and
DLBCL not otherwise specified (NOS)
Transformed DLBCL from indolent histology (tDLBCL) and

Follicular lymphoma Grade 3B.
 

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Programming T-cells to fight lymphoma and CLL  PAL
We've added a Trial Finding query to include CARS that target other antigens (cd20, cd22 and cd19)
We've added links to recent reports at ASH and a review article published Dec 2015
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Top institutions not reporting clinical trial results as required http://bit.ly/1RmvwnY

�Stanford University, Memorial Sloan Kettering Cancer Center, and other prestigious medical research institutions have flagrantly violated a federal law requiring public reporting of study results, depriving patients and doctors of complete data to gauge the safety and benefits of treatments, a STAT investigation has found.
The violations have left gaping holes in a federal database used by millions of patients, their relatives, and medical professionals, often to compare the effectiveness and side effects of treatments for deadly diseases such as advanced breast cancer.
The worst offenders included four of the top 10 recipients of federal medical research funding from the National Institutes of Health: Stanford, the University of Pennsylvania, the University of Pittsburgh, and the University of California, San Diego. All disclosed research results late or not at all at least 95 percent of the time since reporting became mandatory in 2008.�

Comment:  Wishing these tidings were glad. Hopefully, providing sunlight on the problem will lead to better adherence. Publishing trial results is an important rule as can inform patient decision making and the conduct of future research. Publishing the results also shows respect to the participants of the clinical trials.

 
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Acalabrutinib (ACP-196) in Relapsed Chronic Lymphocytic Leukemia � NEJM http://bit.ly/1IHaePm
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EZH2 inhibitors  Dr. Melnick describes in video (epigenetic)   Find Trials
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New query added to Trials of Interest - PAL's Picks
Open controlled (potentially practice changing) studies for:
All Lymphoma OR CLL | CLL | Follicular | DLBCL | MCL| MZL | T-cell | WM
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DRAFT:
Proposing reimbursement for study participation
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DRAFT: 
An Advocate's Perspective on Participation in Phase I Trials  
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Incidence of Hypogammaglobulinemia in Pts Receiving Rituximab and Use of IV Immunoglobulin for Recurrent Infections http://1.usa.gov/1I0ihGA
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ASH: Ublituximab (anti-cd20) + TGR-1202 (PI3Kδ inhibitor) Demonstrates Activity and a Favorable Safety Profile in Relapsed/Refractory B-Cell NHL and High-Risk CLL: Phase I Results http://bit.ly/1Ygo0vX  

Related study of interest:
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ASH: Phase II Trial of Ofatumumab (next gen cd20 antibody- GA-101 or Gazyva) in
Previously Untreated Follicular Lymphoma CALGB 50901 (Alliance) http://bit.ly/1HKbgnL

Comment: Important finding, but not what was hoped for. Ofatumumab was expected to be a significant improvement over Rituxan. This study does not support this ... at least for follicular lymphoma. The silver lining is that this finding might serve to hold down the cost of Rituxan which remains the standard and is soon to be off-patent.  The findings will also guide future research.
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Study of interest
Testing KTE-C19 (CAR t19) in Relapsed/Refractory Mantle Cell Lymphoma (MCL) http://1.usa.gov/1M4Nebh  
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PAL topic: Settings (indications):  our unique clinical circumstance
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Nov 2015: 
NEPA
Added to ASCO Guidelines on Antiemetic (anti-nausea) Use http://wb.md/1HwV0Xj
 
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A phase I/II multicenter, open-label study of the oral histone deacetylase inhibitor Abexinostat in relapsed/refractory lymphoma. - PubMed | Full report | Results | Find trials

Very encouraging results, particularly for follicular lymphoma
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Trial of interest:
Testing Duvelisib (IPI-145) With Rituximab (R) & Bendamustine (B) vs BR +Placebo relapsed Indolent NH #Lymphoma - http://1.usa.gov/1GksTzo
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Melnick:
Figuring out how a genetic mutation implicated in non-Hodgkin lymphoma drives disease ow.ly/SryUL #lymsm
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PAL update:
Quality of Life and other Patient Reported Outcomes
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Novel new study drug:
Testing IPH2201 (checkpoint inhibitor) With Ibrutinib for Relapse or Refractory CLL 1.usa.gov/1QK56sM

Background:
checkpoint inhibitor - IPH2201: first-in-class anti-NKG2A mAb | Innate Pharma bit.ly/1O0BckD
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PAL study of interest:
Testing Pembrolizumab (pd1 antibody)with R-CHOP for Previously Untreated DLBC #Lymphoma -1.usa.gov/1V988b2
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PAL study of interest:
Testing Idelalisib With BI 836826 (anti-cd37) in #CLL 1.usa.gov/1LqF3Y4
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PAL study of interest:
Testing Selinexor and Ibrutinib in Relapsed or Refractory Chronic #CLL or Aggressive NH #Lymphoma - 1.usa.gov/1NQXYeS  (transformed FL are also eligible)
 
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Selinexor, a selective inhibitor of nuclear export (SINE), is enhanced through combination with standard therapies bit.ly/1Qz0BBg
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Farrukh T. Awan, MD
How I Manage Relapsed Chronic Lymphocytic Leukemia #CLL http://bit.ly/1QvkY2I
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Role of consolidation with yttrium-90 ibritumomab tiuxetan (Zevalin) in patients with advanced-stage follicular lymphoma http://1.usa.gov/1UQFGQB 
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Rational for sequential targeting of Bruton tyrosine kinase and Bcl-2 to overcome resistance in mantle cell lymphoma http://1.usa.gov/1FCSZb9
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Troubling: NHS England to De-List More Blood Cancer Agents in Preparation for New Drug Provision System in 2016 http://bit.ly/1VQWX9a
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Background and video on Selective BCL-2 Inhibitor (venetoclax) | BioOncology http://bit.ly/1O122KO
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Immune Response, Toll Like Receptors (TLR) Pathway - animation http://bit.ly/1JQFwOJ
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DLBCL patients who are event-free at 24 months after treatment
have a normal life expectancy. http://1.usa.gov/1UHvDb8 
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Alvarez et al. CLML 2014
What Determines Therapeutic Choices for Elderly DLBCL Pts? [Portugal]  ow.ly/Rv5PF

CONCLUSION:  This was the first characterization of the clinical care of elderly Portuguese patients with DLBCL. We showed that R-CHOP is effective even in patients > 79 years, emphasizing that treatment decisions based on age alone can compromise treatment efficacy and outcome in fit patients.
 
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NCI
Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events
brochure PRO-CTCAE.pdf
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2015, technical:
Blood Cancer Journal - Whole-exome analysis reveals novel somatic genomic alterations associated with outcome in immunochemotherapy-treated diffuse large B-cell lymphoma http://bit.ly/1JHlxB1 (full paper)
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United States #Cancer Statistics released 1.usa.gov/1NBD5FC
You can find interesting relationship between state versus national averages for various cancer types.
 
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Randomized Trial of Lenalidomide Alone Versus Lenalidomide Plus Rituximab in Patients With Recurrent Follicular Lymphoma: CALGB 50401 (Alliance) http://bit.ly/1hfqhXU 
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2015 Blood Journal
Engineered T cells CAN fight malignant T cells http://bit.ly/1Udu30z  more study needed however.
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CAR T-cell therapy:
The role of physical barriers and immunosuppression in #lymphoma: http://ow.ly/RjiUT 
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Aug 2015:
Blood Journal | Cell-of-origin of transformed follicular lymphoma http://bit.ly/1fGoVnS

We report that the expression of IRF4 is an independent predictor of early transformation (hazard ratio 13.3, P < .001). We also show that composite histology at the time of transformation predicts favourable prognosis.
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Update:  Research Advocacy topic
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Testing Anti-ICOS (MEDI-570) in Peripheral T-cell Lymphoma Follicular Variant or Angioimmunoblastic T-cell #Lymphoma http://1.usa.gov/1MwTcCu

Related background: B Cells in Health and Disease � Leveraging Flow Cytometry to Evaluate Disease Phenotype and the Impact of Treatment with Immunomodulatory Therapeutics http://bit.ly/1EAIe8L

Recent advances in T cell immunology have identified a specialized subset of CD4 T cells that provide help to B cells attempting to form a germinal center. This population has been called T follicular helper cells (TFH) (Crotty, 2011). Na�ve CD4 T cells become activated in the T cell zone of the secondary lymphoid organ. The inducible costimulator, ICOS, is expressed, and ICOS engagement drives the upregulation of CXCR5 and BcL6, migration toward the B cell zone and differentiation into a TFH (Choi et al., 2011).
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Aug 2015 - from Lancet:
Integration of gene mutations in risk prognostication for follicular lymphoma: a retrospective analysis of a prospective clinical trial and validation in population-based registry - http://bit.ly/1Jfpnp8

authors comment: "a promising approach to identify the subset at highest risk of treatment failure."

We established a clinicogenetic risk model (termed m7-FLIPI) that included the mutation status of seven genes (EZH2, ARID1A, MEF2B, EP300, FOXO1, CREBBP, and CARD11), the Follicular Lymphoma International Prognostic Index (FLIPI), and Eastern Cooperative Oncology Group (ECOG) performance status.

In the training cohort, m7-FLIPI defined a high-risk group (28%, 43/151) with 5-year failure-free survival of
38�29% (95% CI 25�31�57�95) versus
77�21% (95% CI 69�21�86�14) for the low-risk group
(hazard ratio [HR] 4�14, 95% CI 2�47�6�93; p<0�0001

Put another way (if we have it right): 
1 in 3 patients in the high risk group (defined by m7-FLIPI) did well at 5-years, compared to
3/4 in the low risk group.  This finding, if validated or accepted as reproducible can be used to select patient with high risk FL for tests of novel treatments as initial treatment ... with the goal of changing the natural history of high risk FL (previously defined after relapse).
 
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Study of interest for CNS Lymphoma, primary
Testing: Ibrutinib and Immuno-Chemotherapy Using
Dose-Adjusted Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, Rituximab (DA-TEDDI-R)

Patients Summary | Trial Summary (PDF)

Location: National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892 |  call
888-624-1937      

Clicks as of 8/14/15: 
New Today: >

 

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PAL update
limitations of Animal models in predicting successful new treatments
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PAL update to Patient Reported Outcomes topic:
Placebo effect on patient reported outcomes in cancer trials
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PD1 ligand associated with poor overall survival in patients with diffuse large B-cell #lymphoma. - PubMed - NCBI http://1.usa.gov/1gmMumj added to topic page
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The ASCO Post:
Study Finds Exercise in Adolescence Linked to Reduced Mortality From Cancer and All Causes http://bit.ly/1gIlFtA 

Comment:  A complementary practice to endorse, wholeheartedly. I can�t think of another besides a healthful and varied diet. The rub, there is nothing to buy or make a profit from � no side effects to treat, if done within our limits. In this case, no hype about magical natural formulae.
 
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Study of interest - relapsed indolent lymphoma:
Testing Ibrutinib / placebo With Either Bendamustine-R or CHOP-R for Previously Treated Indolent non-Hodgkin lymphoma http://1.usa.gov/1Ht0c2L

From protocol: "This is a randomized (individuals assigned to study treatment by chance), double-blind (individuals and study personnel will not know the identity of study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study in approximately 400 adult participants with follicular lymphoma or marginal zone lymphoma.

... All participants will receive 6 cycles of background immune-chemotherapy with either BR or R-CHOP in combination with either placebo (Arm A) or ibrutinib (Arm B). Selection of background immune-chemotherapy will be based on prior treatment history and cardiac function.

After completion of background immune-chemotherapy, study drug (ibrutinib or placebo) will continue until disease progression, unacceptable toxicity, or study end, whichever comes first. Assessment of tumor response and progression will be conducted in accordance with the Revised Response Criteria for Malignant Lymphoma. Serial pharmacokinetic (study of what a drug does to the body) blood samples will be collected. Safety will be assessed throughout the study.
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Study of interest for previously untreated follicular lymphoma
Efficacy of Response-adapted Strategy in Follicular Lymphoma - ClinicalTrials.gov http://1.usa.gov/1h7MjMr
Purpose: "Recently, the availability of Rituxan has substantially changed therapeutic approach to FL patients, since its combination with chemotherapy has improved response rates, progression free survival (PFS) and overall survival (OS). Based on the results of recently completed randomized studies the standard treatment for patients with FL should consist of an initial therapy with R-CHOP combination followed by two-year maintenance with R. Although results of randomized trials confirmed that this approach results in an improved patients' outcome and made a step forward in the management of patients with FL, one important question that can be raised is if this approach is really needed for all patients with FL or if some of them could benefit from a reduced intensity treatment achieving the same results in terms of outcome and survival . This question is of particular interest for newly diagnosed patients for whom maintenance does not affect OS.   More recent data demonstrated that the outcome of patients with FL can be further predicted by evaluating the quality of response to therapy studying minimal residual disease (MRD). This project addresses the objective of evaluating if combining clinical response assessed on FDG-PET scan and molecular response measured through MRD detection could permit to single out groups of patients at different risk of progression and to consequently modulate maintenance therapies, with the aim to provide clinicians a more rational use of the available diagnostic and therapeutic resources."
 
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Comments on chemo PAL
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PAL update:
Red flags and free speech - tips on identifying implausible claims about cures for cancer   | PDF version
 
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Testing Lirilumab With Rituximab for Relapsed, Refractory or High-risk Untreated Chronic Lymphocytic Leukemia (CLL) http://1.usa.gov/1Djdng9

Search of: Lirilumab | lymphoma OR CLL - List Results - ClinicalTrials.gov http://1.usa.gov/1LcQMtK

Poster: Phase 1 dose-escalation study of lirilumab (IPH2102, BMS-986015, LIRI),
a fully human anti-KIR monoclonal antibody in patients with various hematologic (HEM) or solid (SOL) malignancies
http://bit.ly/1TFc9Fl

"The blockade of KIR by LIRI fosters the activation of NK cells, selectively enhancing the cytotoxicity of NK cells against tumor cells without affecting healthy tissues."
 
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Updated: Considerations at relapse of indolent lymphoma
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Patient-reported outcomes (PRO) in| lymphoma studies - ClinicalTrials.gov http://1.usa.gov/1QZgCEX
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Patient-reported outcomes (PRO) in cancer - ClinicalTrials.gov http://1.usa.gov/1dsBRfU
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Early-Stage Nodular Lymphocyte-Predominant Hodgkin Lymphoma: The Impact of Radiotherapy on Overall Survival. http://1.usa.gov/1RHhCJ0
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Belinostat for Relapsed or Refractory Peripheral T-Cell Lymphoma: Results of the Pivotal Phase II BELIEF Study http://bit.ly/1Ikqsf6
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Skeptical Raptor 2015:
Marijuana and cancer � what are facts and what�s just smoke  http://bit.ly/1e80VcE

Smoke ... I mean the assertion is just smoke.
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A Surprising Match: Cancer Immunotherapy and Mismatch Repair | NIH Director's Blog http://1.usa.gov/1BH8mCG

snip: ... it supports the hypothesis that immunotherapy may be most effective against tumors with many mutations. (In the new study, the tumor cells deficient in mismatch repair contained more than 20 times as many mutations, on average, than tumor cells proficient in mismatch repair.) The idea is that the greater the number of DNA glitches in a tumor cell, the more abnormal proteins it will produce�and the more abnormal proteins that are generated, the greater the odds that the body�s immune cells will regard the tumor cells as �foreign� and target them for destruction.
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PAL study of interest:

Testing engineered t-cells (CART19 /KTE-C19) in chemo-refractory Aggressive Lymphoma (NHL) � including transformed FL - ClinicalTrials.gov http://1.usa.gov/1HWFk4v  
Related report: *OncLive 2015:
AR-Modified T-Cell Therapy Shows Durable Response in Non-Hodgkin Lymphoma http://bit.ly/1QJGDbf
 
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PAL study of interest:

Relapsed aggressive lymphoma: KPT-330 + RICE for Relapsed/Refractory Aggressive B-Cell #Lymphoma, including transformed FL http://1.usa.gov/1HMlyqV

Technical Background on KPT-330 and related agents: Selective inhibitors of nuclear export for the treatment of non-Hodgkin�s lymphomas
http://1.usa.gov/1lVKX7u

Tumor suppressor genes are genes that begin the cell death process when defects develop in a cell ... to protect against cancer. The tumor suppressor genes are de-activated in cancer cells ... allowing the cells to persist and to be resistant to cancer drugs. Drugs that activate tumor suppressor genes have the potential to overcome drug resistance.
 
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Trial Talk ... experts you can consult for second opinions and also ask about clinical trials
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Highlighting Agents that Target Disease Pathways
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Dose - the importance of getting it right
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DLBCL page
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T-cell page
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Hodgkins Lymphoma page
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Medscape 2015:
For Refractory CLL, Venetoclax's (ABT 199) CR rate Is Tops http://wb.md/1BiYM8M 

snip: Dr Barr said, again, that this degree of MRD negativity is "unparalleled." Six patients were able to interrupt venetoclax after achieving a complete response or CRi, and while all six remained free of recurrence after a median time of 12 months (0-21) off the therapy, one MRD-positive patient had asymptomatic progression at 23.7 months after stopping therapy.

PAL query to find ABT 199 trials: http://1.usa.gov/SRZotl
 
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Polatuzumab Vedotin (PoV) is an antibody that binds to cd79b that delivers a drug payload.

* ASCO 2015: Durable responses: polatuzumab vedotin (CD79b antibody-drug conjugate) in relapsed/refractory follicular lymphoma http://bit.ly/1K6TuPM 

* PAL query for Polatuzumab Vedotin (PoV)
For trials see: http://1.usa.gov/1sd80LK 
 
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DLBCL Study of interest:  Rituximab and Combination Chemotherapy With or Without Lenalidomide for Newly Diagnosed Stage II-IV DLBC Lymphoma http://1.usa.gov/1BKHM6a
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Costs page

New Push Ties Cost of Drugs to How Well They Work - WSJ http://on.wsj.com/1GEYvhm  Your thoughts?

Comment:  What is worse than getting no treatment effect, lots of side effects, and having to sell your house to pay for it?

Pay for performance is an interesting idea. Among the deviling details would be how to define performance and if it can/should be based on individual vs. aggregate outcomes? Not to mention how you attribute good or bad performance to parts of combination therapy? It seems doable, however � that prices for drugs on patent can be scaled in some ways to make the system fair to patients and sustainable for the healthcare system � without trashing incentives to develop and test new drugs.

A performance-based system, might help to focus research on achieving bigger clinically meaningful gains and on identifying and validating predictive biomarkers � to limit unproductive toxicities � physical and financial.  KarlS

 
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Medicare Plan Finder
for Health, Prescription Drug and Medigap plans http://1.usa.gov/1Eo9LbH 
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Medicare & You | Medicare.gov http://1.usa.gov/1IPWPTV
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CLL - Weill Cornell 2015:
FDA Grants Breakthrough Therapy Designation to Venetoclax (ABT-199)
for Patients with Relapsed/Refractory CLL with 17P Deletion http://bit.ly/1cmRGoX
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* The ASCO Post:
Researchers Discuss Pilot Study on Hallucinogenic Therapies for Cancer Anxiety http://bit.ly/1J7nTwN 

* PAL recommended - Medpage Today 2015:
Follicular Lymphoma: Watch/Wait Appropriate but Not Simple: Many patients can safely delay treatment, some cannot or maybe should not. http://bit.ly/1H52pBk

* Medpage Today 2015:
Expanding Options for Follicular Lymphoma Patients in Relapse; Studies of the microenvironment and immune system spark enthusiasm. http://bit.ly/1Eln0v5

*OncLive 2015:
Improving Outcomes in Mantle Cell Lymphoma http://bit.ly/1IsPAPO

* Science Daily 2015:
New treatment option for subtype of aggressive lymphoma ALCL http://bit.ly/1RwMwGC

* Eureka 2015:
'Dr. Google' doesn't know best -- search engine self-diagnosis and 'cyberchondria' http://bit.ly/1IO0sIP

* Medpage Today 2015:
Follicular Lymphoma: Watch/Wait Appropriate but Not Simple: Many patients can safely delay treatment, some cannot or maybe should not. http://bit.ly/1H52pBk

 
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This looks to be a registration trial based on the size (n=400) and that it's a controlled study with standard rituxan as the reference group. Registration studies are of particular importance to us patients and caregivers because they can be the basis for changing practice if the study is positive.

Testing IPI-145 (Duvelisib) With Rituximab vs Rituximab in Previously Treated Follicular Lymphoma - ClinicalTrials.gov http://1.usa.gov/1niDlai

Here's a technical article on the signaling target of this agent.
DEVELOPMENT OF DRUGS TARGETING THE PI3K SIGNALLING PATHWAY IN LEUKAEMIAS AND LYMPHOMAS http://bit.ly/1QqrurX


snip: "The PI3K family of signalling enzymes play a key role in the transduction of signals from activated cell surface receptors controlling cell growth and proliferation, survival, metabolism, and migration.

The intracellular signalling pathway from activated receptors to PI3K and its downstream targets v-akt murine thymoma viral oncogene homolog (Akt) and mechanistic target of rapamycin (mTOR) is very frequently deregulated by genetic and epigenetic mechanisms in human cancer, including leukaemia and lymphoma."
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Daratumumab
(immune-modulating antibody - targeting cell surface receptor cd38)

A fully human monoclonal antibody directed against the cell surface glycoprotein CD-38 with potential antineoplastic activity. The binding of daratumumab to natural killer (NK) cells mimics the normal CD38-CD31 interaction on the NK cell surface.

CD38 is also present on multiple myeloma (MM) cells and plasma leukemia cells; this agent may preferentially bind these cells, triggering antitumoral antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). CD38, a cell surface glycoprotein, is present on various immune cells and has been shown to regulate the cytotoxic response of activated NK cells.

Preclinical report: Daratumumab, a Novel Human Anti-CD38 Monoclonal Antibody for the Treatment of CLL and B-Cell Non�Hodgkin Lymphoma http://bit.ly/1coqc22 

Testing Daratumumab in Relapsed/Refractory b-cell lymphoma - ClinicalTrials.gov http://1.usa.gov/1EviaPN 

Search of: lymphoma OR CLL | Daratumumab - List Results - ClinicalTrials.gov http://1.usa.gov/1Js2nRj
 
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Testing Mocetinostat (HDAC inhib) w Brentuximab Vedotin in Patients With Relapsed or Refractory #Hodgkin #Lymphoma http://1.usa.gov/1Q6Wf4W 

mocetinostat
A rationally designed, orally available, Class 1-selective, small molecule, 2-aminobenzamide HDAC inhibitor with potential antineoplastic activity. Mocetinostat binds to and inhibits Class 1 isoforms of HDAC, specifically HDAC 1, 2 and 3, which may result in epigenetic changes in tumor cells and so tumor cell death; although the exact mechanism has yet to be defined, tumor cell death may occur through the induction of apoptosis, differentiation, cell cycle arrest, inhibition of DNA repair, upregulation of tumor suppressors, down regulation of growth factors, oxidative stress, and autophagy, among others. Overexpression of Class I HDACs 1, 2 and 3 has been found in many tumors and has been correlated with a poor prognosis.

NCI Drug dictionary - cancer.gov 
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PubMed
Disease characteristics, treatment patterns, prognosis, outcomes and lymphoma-related mortality in elderly follicular lymphoma in US http://1.usa.gov/1DOWg5T

Data from the National LymphoCare Study (a prospective, multicentre registry that enrolled follicular lymphoma (FL) patients from 2004 to 2007) were used to determine disease characteristics, treatment patterns, outcomes and prognosis for elderly FL (eFL) patients. Of 2650 FL patients, 209 (8%) were aged >80 years; these eFL patients more commonly had grade 3 disease, less frequently received chemoimmunotherapy and anthracyclines, ....

 
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Frontline rituximab monotherapy induction versus a watch and wait approach for asymptomatic advanced-stage follicular lymphoma: A cost-effectiveness analysis - Prica - 2015 - Cancer - Wiley Online Library http://bit.ly/1IrU3Th

Comment: from the summation and abstract it's not possible to judge the quality of the study methods. One would hope that the abstract would mention the number of patients studied ... to at least begin to estimate the significance of the findings. It seems counter-intuitive that a cost finding could be made ahead of a survival finding (for w&w vs. Rituxan when there is no need to treat.) Another consideration is if those on w&w will necessarily need a chemo-based therapy when treatment is needed. Also important to know is if the sponsor of R sponsored the study.

So I would not take this report as direct or indirect evidence of a practice-changing finding without having much more information. Perhaps expert commentary based on the full text of the report will follow and assist.  (KarlS)

 
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PAL subtopic: Epigenetics and diet as treatment for cancer?
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New topic: Hepatitis C and lymphoma
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2011 - full text:
Hepatitis C virus-related B cell subtypes in non Hodgkin's lymphoma http://1.usa.gov/1Givglc
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2015 - abstract:
Antiviral therapy: better survival in patients with hepatitis C virus and B-cell non-Hodgkin lymphomas, http://1.usa.gov/1J6fzOO
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Lancet 2015:
Carcinogenicity of tetrachlorvinphos, parathion, malathion, diazinon, and glyphosate http://bit.ly/1HrIt9W
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WALDENSTROM'S

*Medscape 2015:
'New Era' in the Treatment of Rare Lymphoma http://bit.ly/1FnZGN6

*Dana Farber 2015:
New Waldenstrom's drug shows sustained benefit at two years http://bit.ly/1Og9HCz
 
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Vitamin D � Health Professional Fact Sheet https://bitly.com/1xRsO1D
 
Information for health professionals about Vitamin D, recommended intakes, sources, intake status, risks of inadequacy or excess, current research on Vitamin...
 
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DAJHO 2015
Clinical Applications and Limitations of Next-Generation Sequencing http://bit.ly/19RAl5n
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JAMA 2015:
Potential chemoresistance after consuming fatty acid in fish, fish oil http://bit.ly/1G7ZuH0 
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Find a Doctor, Specialist oncologist,
Dentist or Hospital Reviews, UCompareHealthCare http://bit.ly/1MbxVjZ
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PAL update:
Risk factors for lymphoma - autoimmune
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Jennifer R. Brown, MD, PhD
How I Manage Deletion 17p Chronic Lymphocytic Leukemia http://bit.ly/1MLTnZE

An important article (often technical) on a validated risk factor for high risk CLL . It includes her recommendations for treatment and how this has changed for this high risk group.
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Safety and efficacy of temsirolimus with Bendamustine in relapsed MCL and Follicular lymphoma - PubMed - NCBI http://1.usa.gov/19IQJpA

Snip:  An objective response was observed in 14/15 patients (93%), including 5 CR (33% all MCL). After a median follow-up of 19 months, 67% of patients are without signs of progression. Temsirolimus can be safely added to BR with promising preliminary activity.

temsirolimus (NCI Dictionary)
An ester analog of rapamycin. Temsirolimus binds to and inhibits the mammalian target of rapamycin (mTOR), resulting in decreased expression of mRNAs necessary for cell cycle progression and arresting cells in the G1 phase of the cell cycle. mTOR is a serine/threonine kinase which plays a role in the PI3K/AKT pathway that is upregulated in some tumors.   cancer.gov

 
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Blood 2015: Casulo, Burack, Friedberg
Transformed follicular non-Hodgkin lymphoma bit.ly/149RgNW

HT (Histologic Transformed FL) is an important cause of morbidity and mortality in patients with FL. Given the biological heterogeneity of HT, and the relative rarity of the event, it is unlikely we will have prospective, randomized trials to guide management of this complication. However, anticipating rapid translation of genomic insights into clinical practice, the implementation of targeted DNA sequencing approaches, and a plethora of novel, targeted therapeutic agents in development, we look forward to a day soon when a molecularly defined, precision therapy approach will replace our current empiricism in the approach to HT.
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An easy way to weigh in from GovTrack.us:
H.R. 460 (113th): Patients� Access to Treatments Act of 2013� http://bit.ly/1LeTZcW

Text of H.R. 460: Patients� Access to Treatments Act of 2013 -  http://bit.ly/1x6bLsB

Key snip: A [plan] that provides coverage for prescription drugs and uses a formulary or other tiered cost-sharing structure shall not impose cost-sharing requirements applicable to prescription drugs in a specialty drug tier that exceed the dollar amount (or its equivalent) of cost-sharing requirements applicable to prescription drugs in a non-preferred brand drug tier (or prescription drugs in a brand drug tier if there is no non-preferred brand drug tier).
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study drug: copanlisib

Copanlisib inhibits the activation of a signaling pathway, which may result in inhibition of tumor cell growth and tumor cell survival NCI

Testing Copanlisib (PI3Kα/β inhibitor) and Rituxan
in Relapsed Indolent B-cell NH Lymphoma (iNHL) - ClinicalTrials.gov http://1.usa.gov/1Ca0eKE
 
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PAL update:
Agents that target disease pathways:  Terminology
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PubMed:
Geographic clustering for cutaneous t-cell lymphoma - PubMed - NCBI http://1.usa.gov/1F0MFMT
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Medscape 2015: (free registration / login required)
Does This Cause Cancer? http://bit.ly/1aLYxHk


Experts discuss evidence for and against BPA, Cell Phones, Artificial Sweeteners, Pesticides, Power Lines ... then give interesting verdicts

Comment: Environment exposures are typically associated with specific types of cancer. The strongest association is between cigarette smoking and lung cancer � which is striking and validated as a causal factor. Here the exposure to carcinogens in the smoke is at a very high level � often over long periods of time.   Unlike many other medical conditions, such as diabetes, limiting our exposure to what caused the condition will not help to reverse a malignant process once it has started � which, in short, is caused by genetic mutations causing the damaged cells to persist and grow abnormally.

� Giving up cigarettes or minimizing exposure to pesticides (good ideas for other reasons) will not undo the damage that was done to the genes in the malignant cells.

Why might this matter?  If I have it right, it means our focus can be on considering science-based approaches to treatment � that target what drives the underlying biology of the disease. (For lymphoma there are many!)  � We can otherwise live normal lives � taking part in a variety of wholesome foods and pleasures without worry about its effect on this medical condition.  KS
 
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MCL - biomarker for high risk:
miR-18b overexpression identifies mantle cell lymphoma patients w poor outcome and improves the MIPI-B prognosticator http://1.usa.gov/1EGKa21
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Welcoming Dr. Michael Bishop as a new scientific advisor to PAL

Thank you Dr. Bishop!
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ASCO Post:
Inotuzumab Ozogamicin (drug-antibody conjugate) Plus Low-Intensity Chemo:
A Winner in Older Patients With Leukemia http://bit.ly/1wnZIGP

PAL query:
inotuzumab ozogamicin trials for lymphoma http://bit.ly/8Bzg5Z

Measuring our impact and interest in this agent:
so far there have been 216 clicks on this query. See https://bitly.com/8Bzg5Z+ )
 
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The ASCO Post, 2015:
Radiotherapy in Good prognosis DLBC Lymphoma? http://bit.ly/1A6adZZ

�In this prospective study, the results demonstrate that in nonbulky limited-stage DLBCL, R-CHOP alone for 4 to 6 cycles induces very high complete response rates, with a very good overall survival and a very low relapse rate,�
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Dr Sharman's Blog 2015;
Syk not Sick http://bit.ly/1z5fvVz 

Dr Sharman discusses yet another pathway targeting drug: "Entospletinib looks to have pretty good efficacy in CLL. It is a twice daily pill. You really cannot compare across studies, but some of the early numbers look a lot like idelalisib. Lots of work left to be done and the trial is still recruiting patients with CLL (trial link here). Talk to your own doctor or seek an opinion at one of the centers offering the trial."

Entospletinib studies in lymphoma or CLL - ClinicalTrials.gov http://1.usa.gov/1ENLgqR 
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The Washington Post
Scientists just made the first map of the human epigenome.  http://wapo.st/17joH2e

See also background on
epigenome http://www.genome.gov/27532724 

Each person's body contains trillions of cells, all of which have essentially the same genome. Yet some cells are optimized for use in muscles, others for bones, the brain, the stomach and the rest of your body. What makes these cells different?

The protein-coding parts of your genome, called genes, do not make proteins all of the time in all of your cells. Instead, different sets of genes are turned on or off in various kinds of cells at different points in time. Differences in the types and amounts of proteins produced determine how cells look, grow and act. The epigenome influences which genes are active - and which proteins are produced - in a particular cell.

PAL topic updates: Epigenetics and HDAC inhibitors
 
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Low-dose pre-phase before conventional-dose chemotherapy for ulcerative gastric diffuse large B-cell lymphoma http://1.usa.gov/1DiNRMf
 
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Cancer. 2015 :  Elderly patients
Disease characteristics, patterns of care, and survival in very elderly patients with DLB-cell lymphoma http://1.usa.gov/1vQwPms 

Abstract conclusion statement: Although patients with DLBCL who were aged >80 years were less likely to receive R-CHOP, this regimen conferred the longest survival and should be considered for this population. Further studies are needed to characterize the impact of treatment of DLBCL on quality of life among patients in this age group.
 
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2015 Recommended Immunizations for Adults:
By Age and By Health Condition  CDC .gov PDF  http://1.usa.gov/19kzESt

Handy, two-page printable tables. 
 
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Measles and Measles Vaccine:
National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention 03/12 http://1.usa.gov/1BfMY6h 

Comprehensive overview and key facts � such as attenuated versus live versions of vaccines.
Live vaccines may be contraindicated in lymphoma and CLL patients.
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10 Ways Doctors and Patients Can Avoid Hating Each Other | Cancer Network http://bit.ly/1CsaVoF
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Being Mortal | FRONTLINE | PBS http://to.pbs.org/1CiCtNg

 ... Many positive comments coming in on this
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PAL update:
Agents that target disease pathways  (a printable brochure)
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Cell Death & Disease:
Potent and selective small-molecule MCL-1 inhibitors demonstrate on-target cancer cell killing http://bit.ly/1E4sTNU

Early but very interesting.  Not yet known if these potent agents can be given safely at therapeutic doses.

See also for background on
Dose - the importance of getting it right
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Being Mortal | FRONTLINE | PBS http://to.pbs.org/1CiCtNg

Many positive comments coming in on this
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PR release 2015:
Genentech (RHHBY) Shows Off Positive Phase III Lymphoma Data From Late-Stage Study http://bit.ly/1F6QJJO

GADOLIN (NCT01059630; GA04753g) is a Phase III open-label, multicenter, randomized two-arm study evaluating Gazyva plus bendamustine followed by Gazyva alone for up to two years compared to bendamustine alone in 413 patients with indolent non-Hodgkin�s lymphoma whose disease progressed during or following Rituxan-based therapy. The primary endpoint of the study is PFS, with secondary endpoints including response rate (RR), best response and overall survival (OS).

Comment:  Well I see to be eligible you had to be found refractory to Rituxan.
https://clinicaltrials.gov/ct2/show/NCT01059630  "Refractory to any previous regimen containing rituximab"

It will be interesting to see how many participants were deemed refractory to Rituxan based on the use of Rituxan as a single agent.
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Clin Cancer Res. 2015 Jan 28. pii: clincanres.2221.2014.

Combination of lenalidomide and rituximab overcomes rituximab-resistance in patients with indolent B-cell and mantle cell lymphomas. http://1.usa.gov/1ztj507

Comments: Interesting and encouraging ... but there are reasons to be cautious about basing conclusions (made by study authors in the title) on this or any single center, single-arm study. Notably it was open only to Rituxan-resistant indolent b-cell lymphoma and MCL. Without a control group it' not known how continued Lenalidomide without Rituxan would have compared to the study combination of continuous Lenalidomide given with standard Rituxan x 4. The study protocol describes also the use of low dos Dexamethasone .. oddly, not described in the abstract. https://clinicaltrials.gov/ct2/show/NCT00783367
 
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Study drug of interest:
Testing Procaspase Activating Compound-1 (PAC-1) in Advanced Malignancies - lymphoma -- ClinicalTrials.gov http://1.usa.gov/1zXsWvV

* Cell Death Dis. 2013 Dec; 4(12): e968.
Procaspase-activating compound-1 (PAC-1) a direct caspase-activating compound� http://1.usa.gov/1zp1pTi 

SNIP:  Procaspase-activating compound-1 (PAC-1) is the first small compound reported to convert procaspase-3 to active caspase-3, in vitro, by chelating inhibitory zinc ions from procaspase-3, thereby inducing effective cell death in tumor cells as well as mouse xenograft models.8, 9 This compound recently received increased attention because of its selective activity on cancer cells and promising antitumor activity in the canine lymphoma model.

Comment:  Very early (its' not known yet if the drug can be given safely at the active dose) but it's very interesting and potentially groundbreaking because it would be a new class of drug targeting a key pathway involved in treatment resistance.
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Youtube 2015:
Experts discuss Initiation and Discontinuation of Ibrutinib From  http://bit.ly/1uYT1EH 
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Onclive 2015;
FDA Expands Approval of Ibrutinib to Waldenstr�m�s Macroglobulinemia  http://bit.ly/1zbBezU
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Notes on the importance of the dose  PAL
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Science Daily 2015:
Added benefit of idelalisib is not proven http://bit.ly/1AvcxNq

Snip:  The Federal Joint Committee (G-BA) specified "best supportive care" (BSC) as appropriate comparator therapy for the assessment of idelalisib in patients with refractory follicular lymphoma. BSC means a therapy that provides the patient with the best possible, individually optimized, supportive treatment to alleviate symptoms and improve quality of life.
 
See PAL's topic page on idelalisib  -
providing background on the accelerated approval of this agent by FDA PAL
 
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Login Req: Dunleavy, Wilson on
Molecular Subtypes of Diffuse Large B-Cell Lymphoma | Cancer Network http://bit.ly/1zIfRSE
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PAL Updates to Guidelines at Diagnosis:
 The biopsy and the Pathology Report
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A study of interest:
Rituximab With or Without Zevalin in Treating Patients With Untreated, Asymptomatic Follicular Lymphoma http://1.usa.gov/1xhtOvA 

One of the comparisons we proposed in the draft survey. What is missing is a w&w control arm, which is a competing standard for untreated, asymptomatic FL. Similarly, the study uses GELF to determine eligibility (no need to treat) with a minimum tumor size of 1.5 cm. It does not include rigorous molecular analysis, which could be especially informative if compared to tumors in an untreated control group.

Strengths include the random allocation, and the good sample size ... and that it compares immunotherapy to immunotherapy (minus immune suppressing chemotherapy pretreatment). I don't expect that QOL will vary significantly. Time to any treatment and Time to Chemotherapy are "soft" longer-term endpoints of interest. By "soft" I mean difficult to interpret because such decisions will be based on physician and patient opinion and not on objective predefined measures.

It will be interesting to see if this study accrues patients - given that either approach can be used off-study. So the key to accrual will be if there is there is genuine uncertainty about the benefit/risk comparison. Patients or physicians with a strong preference for either will do so off study. Here the risks of Zevalin may be perceived as being higher than for Rituxan - especially in the long term. This might be mitigated by a better anticipated CR rate and durations of remissions for Zevalin (the hypothesis) and that the safety of RIT is better (as for other treatments) in treatment-naive patients.

 
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Frontline Brentuximab vedotin in patients with CD30+ peripheral T-cell lymphomas: results of a phase I study. http://1.usa.gov/16DhbPz
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Autologous stem cell transplantation with in vivo purged progenitor cells in relapsed follicular lymphoma, abstract http://1.usa.gov/1GF2pob

After a median f-up of 6.7 years (range 1.5-13.6), 53% are still in CR. These data show that prolonged PFS is achievable in relapsed/refractory patients with high dose autologous transplantation of in vivo purged progenitor cells.

On this: "Preliminary studies using rituximab as in vivo purging during mobilization were effective in collecting lymphoma-free progenitor cells [11�16]. It has also been shown that the efficiency of harvested peripheral blood stem cell (PBSC) is not adversely affected by rituximab, and that engraftment and hematopoietic recovery are not compromised [17, 18].

*
Immunochemotherapy with in vivo purging and autoSCT induces long clinical & molecular remission follicular lymphoma http://bit.ly/13nsnxB
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PAL update:
Questions for your doctor
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Drug-resistant follicular lymphoma cancer stem cells interacts with follicular dendritic cells http://1.usa.gov/1zAB8RG 

snip: In summary, we identified a novel CSC (cancer stem cell) population in FL and its signalling mechanism of interaction with the niche cells. Current treatments for FL are not curative for the majority of patients and were designed and deemed successful based on the response of the bulk population of tumour cells (Reya, et al 2001). Effects on a rare CSC population or on cells in the supportive microenvironment are unknown but presumed to be inadequate given the rates of relapse in FL. Understanding the essential signals for tumour chemoresistance and survival produced by FDC in FL may help develop novel therapeutic strategies (Burger, et al 2009). FL-SC biomarkers may also serve as prognostic markers to classify patients at higher risk of transformation or suggest alternative treatments.

The overall limitation of the current study is the considerable reliance on cell line-based studies with confirmation of the results using patient specimens. Given the limited availability of clinical specimens and the rare CSC population, it is a reasonable strategy to use a cell line model for exploratory experiments but requiring confirmation in clinical specimens. In future studies of FL, a much larger effort would be required to perform lymph node biopsies rather than fine needle aspirations in FL patients in order to collect a larger number of cancer cells to perform FL-SC studies. We believe that our studies, which identify and characterize the FL-SC and its interactions with the tumour microenvironment, are an important step in the development of biologically-based, curative treatments for FL.
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Medscape 2014 with video and text:
Double-Hit Lymphomas Explained, With Surprising EPOCH-R Data http://bit.ly/137qRzI


Cheson and Zelenetz on surprising reports at ASH
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TCGA Updates ‏@TCGAupdates
Insights into cancer biology through next-generation sequencing by Dr S Nik Zainal http://ow.ly/FBCNv 
 
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Consumer Reports News
Why is the health insurance Out-of-Pocket Maximum such a big deal? -  http://bit.ly/1GylTsI 

Especially important to consider for anyone with a chronic medical condition!
 
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Blood 2014: Transformed follicular non Hodgkin lymphoma http://bit.ly/1Gwptn4

Technical in large sections, but also contains therapeutic approaches of importance to patients - and encouraging news on improved outcomes in the Rituxan era.
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Science Based Medicine 2014:
Risks of CAM Treatments for Cancer http://bit.ly/1DaAsGx 
 
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Lymphoma SEER Statistics 1975-2011
5-Year Relative Survival (Percent)  by Age at Diagnosis 2004-2010 SEER
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Lymphoma Statistics - Rate, Count, and Annual Percentage Change - by subtype
Prepared by PAL from SEER database 2014  PDF

Surprising/alarming rise in Mediastinal large B-cell lymphoma
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Event-Free Survival at 12 Months (EFS12) from Diagnosis Is a Robust Endpoint for Disease-Related Survival in Patients with Follicular Lymphoma in the Immunochemotherapy Era 

Important milestone at 12 months helps to predict favorable outcomes.
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Patient to patient guidance from CT (wise words):
About finding, evaluating, choosing clinical trials About finding, evaluating, choosing clinical trials
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Updated December 2014:
"Giving" Tissue and Blood for Research - an advocate's perspective Giving-blood-and-tissue-2014.pdf
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New Research in Follicular Lymphoma http://bit.ly/1BtrUsA 

Dr. Wilson on the importance of new classes of agent (such as targeting b-cell signaling ... with comment on how we appear to be curing FL in some cases ... without using the C word.
 
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Added to PAL's trials of interest
Selinexor and Ibrutinib in Treating Patients With relapsed or refractory CLL or Aggressive Non Hodgkins Lymphoma - ClinicalTrials.gov http://1.usa.gov/1AvkvFV

Selinexor (KPT-330) lymphoma trial query - ClinicalTrials.gov http://1.usa.gov/1xs0cJv
Report ASH 2014: The Oral Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) Demonstrates Broad and Durable Clinical Activity in Relapsed / Refractory Non Hodgkin�s Lymphoma (NHL)

 
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Blinatumomab wins accelerated approval for Ph-negative relapsed or refractory ALL - 12/3/14 http://ln.is/ow.ly/d6XpY 

Comment: This agent targets cd19 and therefore might be used off-label for b-cell lymphoma in cases where there are no effective options (noting that biTE also has significant risks). The accelerated approval (based on a single-arm study) could also spur additional study in high-risk NHL. A report I've copied further below describes clinical experience in other b-cell malignancies. 

The approval was based on the achievement of durable complete remission (CR) and response with a reduction in minimal residual disease (MRD) to less than 10-4 in a multicenter single-arm trial (Protocol MT103-211) that enrolled 185 patients with R/R ALL. Blinatumomab was administered by continuous infusion for 4 weeks of a 6-week cycle. Up to two cycles were used for induction and three cycles for consolidation.



Paper on this agent: Unleashing the clinical power of T cells: CD19/CD3 Bispecific T cell engager (BiTE�)
antibody Blinatumomab as a potential therapy http://bit.ly/1yUZPYo 

Clinical responses were seen at doses of 15 μg/m2/day and higher. At 60 μg/m2/day, the overall response rate (ORR) was 75% across indolent lymphoma subtypes (18 out of 24 patients) with the highest response rate in follicular lymphoma (80%). Additionally, clearance of tumor infiltrate in the bone marrow was seen in 5 out of 6 patients with bone marrow involvement. No objective responses were seen below the 15 μg/m2/day dose (27).
 
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Biomarker update:
Elevated serum levels of IL-2R, IL-1RA and CXCL9 are associated with poor survival in follicular lymphoma http://1.usa.gov/1v6K8wt
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ASH: R-Benda Vs R-CHOP As Initial Treatment for Advanced Stage Low Grade Follicular Lymphoma:
A Matched-Pair Analysis http://bit.ly/1y3JPTT

An interesting approach to comparing outcomes in different studies - showing differences in the populations receiving one or the the other treatments, such as differences in SUV or meeting GELF criteria for need to treat.
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ASH: T Cells Expressing CD19-Specific Chimeric Antigen Receptors Inhibited By
Indoleamine 2,3-Dioxygenase in Tumors http://bit.ly/1y3crwK


Targeting a mechanism of resistance to CART19
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Bexxar revisited - comments on it's discontinuation by GSK
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ASH 2014 oral session abstracts on follicular lymphoma  - compiled 
DLBCL oral sessions added today
Paper: Quality of Life at Diagnosis Independently Predicts Survival in Patients with Aggressive Lymphoma http://bit.ly/1qPcHZN
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PAL update:
Kidney toxicity - background on treatment related risks and how to manage  PAL
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NEJM ,
Changes in Medical Errors after Implementation of a Handoff Program � http://bit.ly/1sjdmTu

Preventable adverse events � injuries due to medical errors � are a major cause of death among Americans. Although some progress has been made in reducing certain types of adverse events,1-3 overall rates of errors remain extremely high.4 Failures of communication, including miscommunication during handoffs of patient care from one resident to another, are a leading cause of errors; such miscommunications contribute to two of every three �sentinel events,� the most serious events reported to the Joint Commission.5 The omission of critical information and the transfer of erroneous information during handoffs are common.6 As resident work hours have been reduced, handoffs between residents have increased in frequency.7

 

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