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T-cell > Cutaneous (CTCL) / Mycosis Fungoides

Last update: 11/30/2015

TOPICS

Clinical Trials for Untreated | Relapsed CTCL 

Overview of Cutaneous T-cell Lymphoma (CTCL)

CTCL is a rare form of lymphoma of T cell origin* that affects the skinSee also about lymphomas

The most common type of CTCL is called mycosis fungoides (MF) and
the systemic stage of MF, Sézary syndrome

Skin manifestations of the disease include patches, plaques, tumors, and erythroderma (inflammation and redness of the skin).

Indolent CTCL is often confined to the skin and can be treated effectively. Aggressive forms can extend beyond the skin to the lymph nodes, blood, and internal organs."  


Comparing Cutaneous T-cell Lymphomas 
 
(by WHO-EORTC classification systems) 

Mycosis Fungoides

(most common) 
 
"Mycosis fungoides (MF) is the most common type of cutaneous T-cell lymphoma (CTCL). 

Indolent clinical behavior

 

Sézary syndrome

Medscape

 considered a late stage, leukemic form of mycosis fungoides 

Aggressive clinical behavior

Subcutaneous panniculitis-like

Medscape

 

 

Large cell types: 

Anaplastic large cell lymphoma

CD30+ Large cell lymphoma

Lymphomatoid Papulosis

Medscape

Primary cutaneous peripheral T-cell lymphoma, unspecified  

/ Pleomorphic cell lymphomas

Medscape

Primary Cutaneous Anaplastic Large Cell Lymphoma

Medscape


Review article, full text:
onlinelibrary.wiley
 

Extranodal NK/T-cell (CD56+) lymphoma, nasal type (WHO) / 

CD30- large cell lymphomas

Aggressive clinical behavior

Medscape

Lymphomatoid Granulomatosis  

Medscape

Granulomatous slack skin disease

Adult T-cell leukemia/lymphoma, 

Pagetoid Reticulosis 

clfoundation.org

Cutaneous T-cell Lymphomas
(Basics and Resources)

Mycosis Fungoides (MF) - most common CTCL 

"Mycosis fungoides is the most common type of cutaneous T-cell lymphoma (CTCL). 

The prevalence estimated at 16,000 to 20,000 in the US.  Unknown cause. Not contagious.  

Early phases of the disease often resemble eczema or psoriasis. 

Diagnosis is generally accomplished through a skin biopsy. Prognosis is related to stage. 

Stages are defined by areas of involvement or presentation as shown below. 

Disease Stage
 
Primary tumor (T)  | Nodal involvement (N) | Distant metastasis (M)

Stage

T N M

Description

IA

Patch phase

T1 N0 M0

Patches, plaques over < 10% of the body surface area

IB

T2 N0 M0

Patches, plaques over > 10% of body surface area

IIA

Skin tumors phase

T1-2 
N1 
M0

Patches, plaques

Clinically abnormal, histologically uninvolved lymph nodes

IIB

T3 
N0-1 
M0

Cutaneous tumors

Clinically normal or abnormal lymph nodes, histologically uninvolved

III

Skin redness  stage

T4 
N0-1 
M0

Generalized erythroderma

Clinically normal or abnormal lymph nodes, histologically uninvolved

IVA

Lymph node stage 

T1-4 
N2-3
M0

Patches, plaques, + tumors, + generalized erythroderma

Clinically normal or abnormal lymph nodes, histologically involved

IVB

T1-4 
N0-3 
M1

Patches, plaques, + tumors, + generalized erythroderma

Clinically normal or abnormal lymph nodes, histologically involved or uninvolved

Visceral (organ) involvement

Adapted from AJCC Cancer Staging Manual 2002:393

 

5 and 10 Year Survival with Mycosis Fungoides/Sezary Syndrome

Rate (%) of:

IA

IB

IIA

IIB

III

IVA

IVB

5-yr disease-specific survival*

100%

96

68

80

-

40

0

10-yr disease-specific survival

97-98

83

68

42

-

20

0

5-yr survival

96-100

73 - 86

49 - 73

40 - 65

40 - 57

15 - 40

0 - 15

10-yr survival

84 - 100

58-67

45-49

20-39

20-40

5-20

0-5

Whittaker, S.J., Foss, F.M., Cancer Treat Rev 2007 33:146

Disease-specific survival rate "The percentage of people in a study or treatment group who have not died from a specific disease in a defined period of time. The time period usually begins at the time of diagnosis or at the start of treatment and ends at the time of death. Patients who died from causes other than the disease being studied are not counted in this measurement" (NCI) 

Treatments: Early stage treatments such as topical therapies: steroid creams, chemotherapy applied to the skin, phototherapy, photopheresis or electron beam radiation may be used.   

MF may lead to extracutaneous (beyond skin) involvement, including blood, lymph nodes, and internal organs of the body (viscera), which can be treated with systemic therapies - chemotherapy 

Infection is an ongoing complication.


Recently approved systemic therapies:

bullet
Bexarotene (1999 for cutaneous CTCL)

Bexarotene gel is a retinoid X receptor agonist and is approved for early-stage mycosis fungoides.90 In clinical trials, it has been shown to have an overall response rate (ORR) of 54% and a complete response rate of 10% in patients with stages IA–IIA mycosis fungoides. It commonly causes skin irritation.  Source: http://1.usa.gov/1mSpyx3
 
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Denileukin diftitox (2008 for cd25+ CTCL),  
bullet
Vorinostat (2006 for cutaneous CTCL), 

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Sézary syndrome (SS)

A leukemic variant of CTCL characterized by 
 
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Blood involvement (Leukemic) with abnormal circulating T cells known as Sézary cells. 

bullet

Pruritic (severe itching) erythroderma - inflammatory skin disease with erythema and scaling that affects nearly the entire cutaneous surface) 

bullet

Enlarge lymph nodes 

Resources: 
 

bullet
Management of cutaneous T cell lymphoma:
new and emerging targets and treatment options http://1.usa.gov/1mSpyx3
bullet
Journal of Hematology & Oncology 2012

Novel therapeutic agents for cutaneous T-Cell lymphoma
Salvia Jain1, Jasmine Zain1 and Owen O’Connor2*  http://bit.ly/RkTRNK
 
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More on CTCL: Medscape | archderm.ama-assn.org | clfoundation.org 


In the News - Research News:

bullet
2015:
Cutaneous T-cell lymphoma: 2016 update on diagnosis, risk-stratification, and management. - PubMed - NCBI http://1.usa.gov/1OzVwZt
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* Youtube 2013:
Cutaneous Lymphomas: Diagnosis and Staging http://bit.ly/1axwlzO
 
bullet

Ontak (Denileukin Diftitox)

Phase III Placebo-Controlled Trial of Denileukin Diftitox for Patients With Cutaneous T-Cell Lymphoma http://bit.ly/1r4l1u1

Clin Lymphoma Myeloma Leuk. 2013
Duration of response in cutaneous T-cell lymphoma patients treated with denileukin Diftitox: results from 3 phase III studies. NCBI http://1.usa.gov/1zDd9kY

 
bullet The ASCO Post, 2013: FDA Approves Mechlorethamine Gel for Cutaneous T-Cell Lymphoma  http://bit.ly/18Ultxa

This gel is the first and only FDA-approved topical formulation of mechlorethamine, which is commonly known as nitrogen mustard. The gel is applied topically once a day and dries on the skin.

Mechlorethamine was approved previously for intravenous treatment of mycosis fungoides, the most common type of CTCL. Topical mechlorethamine preparations are currently recommended for the treatment of early-stage CTCL. Prior to approval of the gel, there were no FDA-approved topical mechlorethamine products; only non-standardized, pharmacy-compounded petroleum ointment or aqueous-based topical preparations were available.
 

bullet
News Medical: FDA grants Fast Track designation to Elorac's
 naloxone topical lotion http://bit.ly/ZleuKY

"topical lotion for the relief of pruritus in patients with cutaneous
T-cell lymphoma (CTCL). There are currently no approved therapeutic
treatment options available to patients and their physicians for pruritus in CTCL."
bullet
Journal of Hematology & Oncology 2012

Novel therapeutic agents for cutaneous T-Cell lymphoma
Salvia Jain1, Jasmine Zain1 and Owen O’Connor2*  http://bit.ly/RkTRNK

Patients with limited stage disease are effectively treated with skin-directed therapies; these include
topical nitrogen mustard, corticosteroids, bexarotene, localized radiotherapy or psoralen plus ultraviolet A therapy, as listed in the NCCN and EORTC guidelines. Most patients will achieve short-term clinical response but will have recurrent disease for many years but still have a normal life expectancy [5-7].

Novel therapeutic agents in cutaneous T-cell lymphoma While the lack of insight into the biology of CTCL has hindered the development of true ‘targeted therapies’, there is now an abundance of new drugs that have shown potentially significant activity either alone or in combination with conventional agents.
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Oncology Times: Photopheresis in the treatment of cutaneous T-cell lymphoma: current status

CTCL - Extracorporeal photopheresis (ECP), an immunomodulating procedure involving treatment of blood with a photoactive agent, was given regulatory approval by FDA as a medical device for the treatment of cutaneous T-cell lymphoma (CTCL) in 1988 [1]. It is one of many treatment options for CTCL.
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Dr. John Zic of Vanderbilt University discusses controversies in cutaneous T cell lymphomas, particularly the difficulties in diagnosis.  Diagnostic Challenges in Cutaneous T-Cell Lymphoma
bullet
Cutaneous T Cell - Brit J Dermatology:
Low-Dose Total Skin Electron Beam Therapy as a Debulking Agent:
An open-label prospective phase II study
bullet
Clinical efficacy of zanolimumab (HuMax-CD4): two phase 2 studies in refractory cutaneous T-cell lymphoma http://bloodjournal.hematologylibrary.org/content/109/11/4655.long
bullet
Phase 2 trial of oral vorinostat  (SAHA) for refractory cutaneous T-cell lymphoma (CTCL) ncbi.nlm.nih.gov

bullet
Clinical efficacy of zanolimumab (HuMax-CD4): two phase 2 studies in refractory cutaneous T-cell lymphoma http://bloodjournal.hematologylibrary.org/content/109/11/4655.long
bullet
Efficacy and tolerability of currently available therapies for the mycosis fungoides and Sezary syndrome variants of cutaneous T-cell lymphoma. Whittaker SJ, Foss FM. Cancer Treat Rev. 2007 Apr;33(2):146-60. Epub 2007 Feb 1. Review. PMID: 17275192
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Pegylated liposomal doxorubicin effective in poor prognosis CTCL medwire-news

Of the 10 patients with Sézary syndrome, six (60%) patients achieved an objective response at the end of treatment, including one complete response and five partial responses. Five (50%) of 10 patients with transformed CTCL achieved an objective response, including one patient who achieved a complete response and was still disease-free after 3 years.
bullet
Phase 2 Data for Romidepsin Showing Durable Response in Refractory CTCL businesswire.com 

"Romidepsin is a novel, cyclic peptide, pan-HDAC inhibitor under investigation for hematologic malignancies"
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ASH: Forodesine HCl active single oral agent for advanced refractory CTCL  abstracts2view.com  | ClinicalTrials.gov

Forodesine is a rationally designed, potent inhibitor of purine nucleoside phosphorylase (PNP) that leads to intracellular accumulation of dGTP and then apoptosis. ... Conclusion: Oral forodesine demonstrates clinical activity in subjects with refractory CTCL, including those with SS, with minimal toxicity to date. 
bullet
Treatment of mycosis fungoides using a 308-nm excimer laser: two case studies.
Dermatol Online J. 2006 Dec 10;12(7):11. PMID: 17459297 
bullet
506U78 (Nelarabine) Results of a phase II study of 506U78 in cutaneous T-cell lymphoma and peripheral T-cell lymphoma: CALGB 59901. Leuk Lymphoma. 2007 Jan;48(1):97-103. PMID: 17325852 | ClinicalTrials.gov
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Anti-cd2 (Siplizumab) antibody (investigational)  ash05 | ClinicalTrials.gov

Siplizumab is a humanized IgG1κ class monoclonal antibody that binds to the CD2 receptor on 
human T- and NK-cells
bullet
Anti-cd30 (SGN-30) antibodies (investigational)  PubMed articles | ClinicalTrials.gov  

CD30 is a promising target for antibody-based immunotherapy of Hodgkin lymphoma (HL) and anaplastic large cell lymphoma.   PMID: 12881320 
bullet
Bexarotene  PubMed articles | ClinicalTrials.gov  
 
( beks-AIR-oh-teen) a retinoids (RET-i-noyds), applied to the skin Acts by interfering with the growth of cells of the tumor. It may be used after other drugs have been tried, and the tumor is still a problem. - MedlinePlus

Dose may be limited by cholesterol/TG elevations. Pretreatment with anti-lipid agents may be needed
bullet
Bexarotene with ONTAK  PubMed articles | ClinicalTrials.gov  
bullet
Extracorporeal photopheresis  PubMed articles | ClinicalTrials.gov
Is thought to induce antigen processing cell activation and apoptosis of CTCL cells
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HDAC inhibitor: Depsipeptide  PubMed articles | ClinicalTrials.gov 

"Depsipeptide, FR901228, has demonstrated potent in vitro and in vivo cytotoxic activity against murine and human tumor cell lines. In the laboratory, it has been shown to be a histone deacetylase (HDAC) inhibitor. In a phase I trial of depsipeptide conducted at the National Cancer Institute, 3 patients with cutaneous T-cell lymphoma had a partial response, and 1 patient with peripheral T-cell lymphoma, unspecified, had a complete response. Sezary cells isolated from patients after treatment had increased histone acetylation. These results suggest that inhibition of HDAC is a novel and potentially effective therapy for patients with T-cell lymphoma."  PMID: 11675364 
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Interleukin 12 Active in Mycosis Fungoides (a T-cell lymphoma)  cancerconsultants.com 

The current study involved 23 patients with mycosis fungoides, all of whom had received more than three prior therapies. These authors reported that 10 patients achieved a partial response (PR), 30% had minor responses and 22% had stable disease.
bullet
Immune modulation  PubMed articles | ClinicalTrials.gov
 
Immune therapy and immune modulation is likely most appropriate as an early treatment; 
not in advanced disease
bullet
Immune therapy  PubMed articles | ClinicalTrials.gov 
 
Improves durability of response in responders to combination therapy.
bullet
Lenalidomide / Revlimid  (investigational)  PubMed articles | ClinicalTrials.gov
 
A potent immune modulating agent. 
bullet
ONTAK (denileukin diftitox)  PubMed articles | ClinicalTrials.gov
bullet
Transimmunization (immune therapy)  Clinical trial: med.yale.edu 

"Transimmunization was developed after years of laboratory research advanced the understanding of the underlying principles of ECP (Extracorporeal, photochemotherapy, or photopheresis). 

The scientific basis of ECP is the ability to stimulate the development of powerful stimulators of the immune system called dendritic cells. Transimmunization is a more efficient means by which to bring these dendritic cells in contact with target cancer cells, before they are returned to the body to stimulate an anti-tumor immune response."

Assessment

bullet
2002
Assessment of tumor burden and treatment response by 18F-fluorodeoxyglucose injection and positron emission tomography in patients with cutaneous T- and B-cell lymphomas. J Am Acad Dermatol. 2002 Oct;47(4):623-8. PMID: 12271315

Treatment

bullet
2006
Treatment of mycosis fungoides using a 308-nm excimer laser: two case studies.
Dermatol Online J. 2006 Dec 10;12(7):11. PMID: 17459297 

Our findings confirm previous observations that the 308-nm excimer laser is a safe, effective, and well-tolerated therapy for early stage MF.
bullet
Phase II Trial of Oral Vorinostat (Suberoylanilide Hydroxamic Acid, SAHA) for Refractory Cutaneous T-cell Lymphoma (CTCL). Blood. 2006 Sep 7; PMID: 16960145 | Related articles 

Eight (of 31) patients achieved a PR, including 7 with advanced disease and 4 with Sezary syndrome. The median Time to Response, Duration of Response, and Time to Progression for responders were 11.9, 15.1, and 30.2 weeks, respectively. Fourteen of 31 evaluable patients had pruritus relief. The most common drug-related AE were fatigue, thrombocytopenia, diarrhea, and nausea.
bullet
International multicenter phase II study of the HDAC inhibitor (HDACi) depsipeptide (FK228) in cutaneous T-cell lymphoma (CTCL): Interim report.  ASCO 2006 

Conclusions: The previously reported efficacy of depsipeptide in CTCL has also been seen in the present study. Duration of response is encouraging. Toxicity is manageable and the study continues to accrue.
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About PUVA - Photopheresis is a process where your white blood cells are separated from the rest of your blood. The white blood cells are exposed the methoxsalen and UV light and then reinfused back into you.  rmhonline.com 
bullet
T-Cell Lymphoma Successfully Treated with Psoralen Plus UV-A Therapy  cancerconsultants.com
According to a recent article in the Archives of Dermatology, Psoralen plus UV-A (PUVA) is an effective treatment for patients with mycosis fungoides (MF), inducing long-term remissions and in some cases, disease cure.
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Immunophenotypic and molecular features, clinical outcomes, treatments, and prognostic factors associated with subcutaneous panniculitis-like T-cell lymphoma: a systematic analysis of 156 patients reported in the literature. Cancer. 2004 Sep 15;101(6):1404-13.  PMID: 15368328 
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HuMax-CD4 Phase II cutaneous T-cell lymphoma (CTCL) studies - 55% of Higher Dose Patients Achieve a Clinical Response in Primary Indication  prnewswire Apr 2004
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Multicenter study of pegylated liposomal doxorubicin in patients with cutaneous T-cell lymphoma. Cancer. 2003 Sep 1;98(5):993-1001. PMID: 12942567
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A complete and durable response to denileukin diftitox in a patient with mycosis fungoides. J Am Acad Dermatol. 2003 Feb;48(2):275-6. PMID: 12582402  PubMed
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Enhanced expression of T-cell activation and natural killer cell antigens indicates systemic anti-tumor response in early primary cutaneous T-cell lymphoma. J Invest Dermatol. 1997 May;108(5):743-7. PMID: 9129226 PubMed
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EPOCH for refractory T-cell NHL Chemotherapy with etoposide, vincristine, doxorubicin, bolus cyclophosphamide, and oral prednisone in patients with refractory cutaneous T-cell lymphoma. Cancer. 1999 Oct 1;86(7):1368-76. PMID: 10506727  PubMed
bullet
Inhibitor of histone deacetylation, depsipeptide (FR901228), in the treatment of peripheral and cutaneous T-cell lymphoma: a case report.  Blood. 2001 Nov 1;98(9):2865-8. PMID: 11675364  PubMed
bullet
Phase II trial of interferon-alpha-2a plus psolaren with ultraviolet light A in patients with cutaneous T-cell lymphoma. Cancer 2002; 95: 569-75.   PubMed
bullet
Treatment of relapsing or recalcitrant cutaneous T-cell lymphoma with pegylated liposomal doxorubicin. J Am Acad Dermatol. 2000 Jan;42(1 Pt 1):40-6. PMID: 10607318  PubMed
bullet
Treatment of cutaneous T cell lymphoma: current status and future directions. 
Am J Clin Dermatol. 2002;3(3):193-215. Review. PMID: 11978140  PubMed
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Treatment of advanced mycosis fungoides by allogeneic stem-cell transplantation with a nonmyeloablative regimen. Bone Marrow Transplant. 2003 Apr;31(8):663-6. PMID: 12692606  PubMed
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Treatment of cutaneous T cell lymphoma: current status and future directions. Am J Clin Dermatol. 2002;3(3):193-215. Review. PMID: 11978140  PubMed  
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 Other Cutaneous lymphomas of t-cell origin

Under construction 


 
bullet

Subcutaneous panniculitis-like (WHO and EORTC)
 
bullet

About Medscape 
 


 
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Anaplastic large cell lymphoma (WHO) - PC CD30+ lymphoproliferative disorders, LyP/PCALCL
/ CD30+ Large cell lymphoma (EORTC) / Lymphomatoid Papulosis (EORTC)
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About Medscape
 


 
bullet

Primary cutaneous peripheral T-cell lymphoma, unspecified (WHO) 
/ Pleomorphic cell lymphomas (EORTC)
 
bullet

About Medscape
 


 
bullet

Primary Cutaneous Anaplastic Large Cell Lymphoma
 
bullet

About Medscape
 


 
bullet

Extranodal NK/T-cell (CD56+) lymphoma, nasal type (WHO) / CD30- large cell lymphomas (EORTC)
 

 

OTHER TYPES:

 

bullet

lymphomatoid granulomatosis 

bullet

About Medscape 

Granulomatous slack skin disease | Adult T-cell leukemia/lymphoma | Pagetoid Reticulosis 

Source: clfoundation.org

CLINICAL TRIALS

Cutaneous T-cell Types:
bullet

Trials for Untreated CTCL | Relapsed CTCL


CTCL Staging Systems

Tumor Burden Index in Cutaneous T-Cell Lymphoma Medal.org

Primary tumor (T) 

T1:  Eczematous patches, papules, or limited plaques covering less than 10% of the skin surface 

T2:  Erythematous patches, papules, or generalized plaques covering 10% or more of the skin surface 

T3: Tumors, one or more 

T4: Generalized erythroderma 

When characteristics of more than one T exist, 
both are recorded and the highest is used for staging,  for example, T3(2). 

Nodal involvement (N):

N0: No clinically abnormal peripheral lymph nodes, pathology negative for CTCL 

N1: Clinically abnormal peripheral lymph nodes, pathology negative for CTCL 

N2: No clinically abnormal peripheral lymph nodes, pathology positive for CTCL 

N3: Clinically abnormal peripheral lymph nodes, pathology positive for CTCL 

Distant metastasis (M)

M0: No involvement of visceral organs 

M1: Visceral involvement (must have confirmation of pathology; organ involved should be specified) 

Other Staging Terminology:

Early stage (T1 and T2)
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IA : < 10% patch/plaque

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IB: > 10% BSA patch/plaque

bullet

IIA: palpable adenopathy

Intermediate stage
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IIB: Cutaneous tumors (T3)

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III: Erythroderma (T4)

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IVA: Node biopsy positive

Advanced state

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Visceral involvement - "referring to the viscera, the internal organs of the body, specifically those within the chest (as the heart or lungs) or abdomen (as the liver, pancreas or intestines)." http://www.medterms.com 

Resources on Staging: http://www.meds.com/pdq/tcell_pro.html#3 

 

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Resources on Cutaneous t-cell lymphomas

bullet
About cutaneous lymphomas 
bullet
eMedicine
bullet
dermnetnz.org
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clfoundation.org
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NCI PDQ
bullet
Dermatology Channel
bullet
Review Article 
bullet
Resources on Staging: http://www.meds.com/pdq/tcell_pro.html#3 
bullet
Cutaneous T cell lymphoma Neeraj Srivastava MD, Nitin Mishra MBBS, Sanjay Singh MD DNB PhD Dermatology Online Journal 14 (8): 16  dermatology.cdlib.org 

Excellent overview but the graphic image of the condition might be disturbing to some ... which may not be typical.  
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Cutaneous T-cell lymphoma dermnetnz.org 

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Treatment Overview

Skin-directed treatments 
(2006 CAC NYC - Foss presentation)

Lesional skin only
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High potency topical steriods

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Bexaratene gel

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Other: Excision; Imiquimod; Photdynamic; UVB laser

Lesional skin only
bullet

UVB

bullet

Topical HN2 or BCNU

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Photochemotherapy

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Radiotherapy

Related treatment resources:

bullet
Protocols for Refractory Disease  PAL

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Resources 

bullet
* Youtube 2013:
Cutaneous Lymphomas: Diagnosis and Staging http://bit.ly/1axwlzO
 
bullet
Clinical abstracts  CTCLconsult.com
bullet
Lymphoma of the Skin (Nov_28_02) 
 
Joseph M. Connors, Eric D. Hsi and Francine M. Foss Abstract  asheducationbook.org
Scroll down to Section III for Cutaneous T-Cell Lymphoma
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Photopheresis Followed by Immunotherapy Improves Responses in Cutaneous T-Cell Lymphoma www.ufscc.ufl.edu 
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About Photopheresis  PAL

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T-Cell Lymphoma Presenting as Benign Dermatoses - includes images  aafp.org
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PDQ -- for Health Professionals NIH
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PubMed Queries on This Subtype of Lymphoma

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 Diagnosis | Review | Therapies | Prognosis
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Clinical Trials

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ClinicalTrials.gov studies for T-cell lymphomas
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For all medical concerns,  you should always consult your doctor. 
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