Treatment statement for Health professionals

Mycosis Fungoides and the Sézary Syndrome Treatment (PDQ®)

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General Information
Cellular Classification
Stage Information
Treatment Option Overview
Stage I Mycosis Fungoides/Sézary Syndrome
Stage II Mycosis Fungoides/Sézary Syndrome
Stage III Mycosis Fungoides/Sézary Syndrome
Stage IV Mycosis Fungoides/Sézary Syndrome
Recurrent Mycosis Fungoides/Sézary Syndrome
Changes to This Summary (02/18/2010)
About This PDQ Summary
Get More Information From NCI

General Information

Mycosis fungoides and the Sézary syndrome (MF/SS) are neoplasias of malignant T lymphocytes that usually possess the helper/inducer cell surface phenotype. These kinds of neoplasms initially present as skin involvement and as such have been classified as cutaneous T-cell lymphomas. [1] These types of lymphomas are included in the Revised European-American Lymphoma classification as low grade T-cell lymphomas, which should be distinguished from other T-cell lymphomas that involve the skin, such as anaplastic large cell lymphoma (CD30 positive), peripheral T-cell lymphoma (CD30 negative, with no epidermal involvement), adult T-cell leukemia/lymphoma (usually with systemic involvement), or subcutaneous panniculitic T-cell lymphoma. [2] [3] These histologic types of T-cell lymphomas are discussed in another PDQ summary. (Refer to the PDQ summary on Adult Non-Hodgkin Lymphoma Treatment for more information.) In addition, a number of benign or very indolent conditions can be confused with mycosis fungoides. Consultation with a pathologist who has expertise in distinguishing these conditions is important. [4]

The prognosis of patients with MF/SS is based on the extent of disease at presentation (stage). [5] The presence of lymphadenopathy and involvement of peripheral blood and viscera increase in likelihood with worsening cutaneous involvement and define poor prognostic groups. [6] The median survival following diagnosis varies according to stage. Patients with stage IA disease have a median survival of 20 or more years. The majority of deaths for this group are not caused by, nor are they related to, MF. [7] In contrast, more than 50% of patients with stage III through stage IV disease die of MF, with a median survival of less than 5 years. [5] [6] [7] A report on 1,798 patients from the SEER database found an increase in second malignancies (standardized incidence ratio of 1.32; 95% confidence interval, 1.15–1.52), especially for Hodgkin and non-Hodgkin lymphoma and for myeloma. [8]

Typically, the natural history of MF is indolent. [9] Symptoms of the disease may present for long periods, an average of 2 to 10 years, as waxing and waning cutaneous eruptions prior to biopsy confirmation. MF/SS is treatable with available topical and/or systemic therapies. Curative modalities, however, have thus far proven elusive, with the possible exception of patients with minimal disease confined to the skin.

Cutaneous disease typically progresses from an eczematous patch/plaque stage covering less than 10% of the body surface (T1) to plaque stage covering 10% or more of the body surface (T2), and finally to tumors (T3) that frequently undergo necrotic ulceration. [4] [10] SS is an advanced form of MF with generalized erythroderma (T4) and peripheral blood involvement at presentation. Cytologic transformation from a low-grade lymphoma to a high-grade lymphoma sometimes occurs during the course of these diseases and is associated with a poor prognosis. [11] [12] A common cause of death during the tumor phase is sepsis from Pseudomonas aeruginosa or Staphylococcus aureus caused by chronic skin infection with staph species and subsequent systemic infections. [10]

References:

Cellular Classification

The histologic diagnosis of mycosis fungoides and the Sézary syndrome (MF/SS) is usually difficult to determine in the initial stages of the disease and may require the review of multiple biopsies by an experienced pathologist.

A definitive diagnosis from a skin biopsy requires the presence of MF/SS cells (convoluted lymphocytes), a band-like upper dermal infiltrate, and epidermal infiltrations with Pautrier abscesses (collections of neoplastic lymphocytes). A definitive diagnosis of SS may be made from a peripheral blood evaluation when skin biopsies are consistent with the diagnosis. Circulating Sézary cells can be confirmed by T-cell receptor gene analysis. [1]

References:

Fraser-Andrews EA, Russell-Jones R, Woolford AJ, et al.: Diagnostic and prognostic importance of T-cell receptor gene analysis in patients with Sézary syndrome. Cancer 92 (7): 1745-52, 2001.

Stage Information

Note: The American Joint Committee on Cancer has recently published a new edition of the AJCC Cancer Staging Manual, which includes revisions to the staging for this disease. The PDQ Adult Treatment Editorial Board, which is responsible for maintaining this summary, is currently reviewing the new staging to determine the changes that need to be made in the summary. In addition to updating this Stage Information section, additional changes may need to be made to other parts of this summary to ensure that it is up-to-date. The changes will be made as soon as possible.

The stages that follow are defined by TNM classification. Peripheral blood involvement with mycosis fungoides or Sézary syndrome (MF/SS) cells is correlated with more advanced skin stage, lymph node and visceral involvement, and shortened survival but probably provides no independent prognostic information beyond that associated with TNM staging. In a multivariate analysis, the two most important prognostic factors are the presence of visceral disease and type of skin involvement.

The American Joint Committee on Cancer (AJCC) has designated staging by TNM classification to define mycosis fungoides. [1]

TNM(B) Definitions

Primary tumor (T)

T1: Limited patch/plaque (<10% of skin surface involved)
T2: Generalized patch/plaque (≥10% of skin surface involved)
T3: Cutaneous tumors (one or more)
T4: Generalized erythroderma (with or without patches, plaques, or tumors)

Pathology of T1–T4 is diagnostic of cutaneous T-cell lymphoma (CTCL). When characteristics of more than one T-type tumor exist, both are recorded and the highest is used for staging, for example, T4(3).

Regional lymph nodes (N)

N0: Lymph nodes clinically uninvolved; the pathology is negative for CTCL
N1: Lymph nodes clinically enlarged, histologically uninvolved; the pathology is negative for CTCL
N2: Lymph nodes clinically unenlarged, histologically involved; the pathology is positive for CTCL
N3: Lymph nodes enlarged and histologically involved; the pathology is positive for CTCL

Distant metastasis (M)

M0: No visceral disease
M1: Visceral disease present

The TNM classification includes a subcategory for patients with CTCL:

Blood involvement (B)

B0: No circulating atypical cells (<1000 Sézary cells [CD4 + CD7-]/mL)
B1: Circulating atypical cells (≥1000 Sézary cells [CD4 + CD7-]/mL)

TNM Stage Groupings

Stage IA

T1, N0, M0

Stage IB

T2, N0, M0

Stage IIA

T1-T2, N1, M0

Stage IIB

T3, N0–N1, M0

Stage IIIA

T4, N0, M0

Stage IIIB

T4, N1, M0

Stage IVA

T1–T4, N2, M0
T1–T4, N3, M0

Stage IVB

T1–T4, N0, M1
T1–T4, N1, M1
T1–T4, N2, M1
T1–T4, N3, M1

References:

Lymphoid neoplasms. In: American Joint Committee on Cancer.: AJCC Cancer Staging Manual. 6th ed. New York, NY: Springer, 2002, pp 393-406.

Treatment Option Overview

Treatment options for patients with mycosis fungoides and the Sézary syndrome (MF/SS) include: [1] [2]

Topical corticosteroids.
Topical chemotherapy with mechlorethamine (nitrogen mustard) or carmustine (BCNU).
Psoralen and ultraviolet A radiation (PUVA).
Ultraviolet B radiation (UVB).
Total-skin electron-beam radiation (TSEB).
Radiation of symptomatic skin lesions.
Interferon-alpha alone or in combination with topical therapy.
Single-agent and multiagent chemotherapy.
Bexarotene (topical gel or oral); retinoids.
Denileukin diftitox (recombinant fusion protein of diptheria toxin fragments and interleukin-2 sequences).
Combined modality treatment.

These types of treatments produce remissions, but long-term remissions are uncommon. Treatment, therefore, is considered palliative for most patients, though major symptomatic improvement is regularly achieved. Survival in excess of 8 years, however, is common. All patients with MF/SS are candidates for clinical trials evaluating new approaches to treatment.

Current areas of interest in clinical trials for MF confined to the skin include combined modality therapies containing both topical and systemic agents such as TSEB combined with chemotherapy, topical mechlorethamine or PUVA combined with interferon, or wide-field radiation techniques with PUVA. Reports are available of activity for extracorporeal photochemotherapy using psoralen; interferon-gamma or interferon-alpha; pentostatin; retinoids; fludarabine; acyclovir; 2-chlorodeoxyadenosine; serotherapy with unlabeled, toxin-labeled, or radiolabeled monoclonal antibodies; cell surface receptor ligand-toxin fusion protein; and, methotrexate. [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] Antigen-specific vaccination using dendritic cells [13] and UVB are also under clinical evaluation.

References:

Stage I Mycosis Fungoides/Sézary Syndrome

Since several forms of treatment can produce complete resolution of skin lesions in this stage, the choice of therapy is dependent on local expertise and the facilities available. With therapy, the survival of patients with stage IA disease can be expected to be the same as age and gender-matched controls. [1] [2]

Treatment options: [3]

Psoralen and ultraviolet A radiation (PUVA). Therapeutic trials with PUVA have shown a 62% to 90% complete remission rate with early cutaneous stages achieving the best responses. Continued maintenance therapy with PUVA at more protracted intervals is generally required to prolong remission duration. [4] [5] [6] PUVA combined with interferon-alpha-2a is associated with a high response rate. [7]

Total-skin electron-beam radiation (TSEB). Electron radiation of appropriate energies will penetrate only to the dermis, and thus the skin alone can be treated without systemic effects. This therapy requires considerable technical expertise to deliver, can result in short- and long-term cutaneous toxic effects, and is not widely available. Based on the long-term survival of these early stage patients, electron-beam radiation therapy is sometimes used with curative intent. [8] [9] [10] Long-term disease-free survival can be achieved in patients with unilesional mycosis fungoides treated with local radiation therapy. [11]

Ultraviolet B radiation is under clinical evaluation.

Symptomatic management with topical corticosteroids.

Topical mechlorethamine (nitrogen mustard). Topical application of mechlorethamine has produced regression of cutaneous lesions, with particular efficacy in early stages of disease. The overall complete remission rate is related to skin stage; 50% to 80% of TNM classification T1, and 25% to 75% of T2 patients have complete responses. Treatments are usually continued for 2 to 3 years. Continuous 5-year disease-free survival may be possible in as many as 33% of T1 patients. [8] [12] [13] [14]

Local electron-beam radiation or orthovoltage radiation therapy may be used to palliate areas of bulky or symptomatic skin disease.

Interferon-alpha alone or in combination with topical therapy, as evidenced in the ECOG-1495 trial.

Bexarotene, an oral or topical retinoid. [15] [16]

Oral methotrexate. [17]

Pegylated liposomal doxorubicin. [18]

Vorinostat, an oral histone deacetylase inhibitor. [19]

Current Clinical Trials

Check for U.S. clinical trials from NCI's list of cancer clinical trials that are now accepting patients with stage I mycosis fungoides/Sezary syndrome. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

References:

Stage II Mycosis Fungoides/Sézary Syndrome

Note: Some citations in the text of this section are followed by a level of evidence. The PDQ editorial boards use a formal ranking system to help the reader judge the strength of evidence linked to the reported results of a therapeutic strategy. (Refer to the PDQ summary on Levels of Evidence for more information.)

No curative therapy exists for patients with stage II disease. The choice of initial palliative therapy is, therefore, dependent on the patient’s symptoms and the local expertise with each modality.

A randomized study of 103 patients compared combined total-skin electron-beam radiation (TSEB) plus combination chemotherapy with conservation therapy consisting of sequential topical therapies. [1] In the latter group, combination chemotherapy was reserved for symptomatic extracutaneous disease or for disease refractory to topical therapies. Patients of any stage were eligible. Although the complete response rate was higher with combined therapy, toxic effects were considerably greater, and no difference was seen in disease-free or overall survival between the two groups. [1][Level of evidence: 1iiA]

Treatment options: [2]

Psoralen and ultraviolet A radiation (PUVA). Therapeutic trials with PUVA have shown a 62% to 90% complete remission rate with early cutaneous stages achieving the best responses. Maintenance therapy with PUVA is generally required to prolong remission duration. [3] [4] PUVA combined with interferon-alpha-2a is associated with a high response rate. [5]

TSEB. Electron radiation of appropriate energies will penetrate only to the dermis, and the skin alone can be treated without systemic effects. This therapy requires a radiation therapy facility with physics support, considerable technical expertise, and precise dosimetry. The therapy can provide excellent palliation with complete response rates of as much as 80%. [6] [7] [8]

Ultraviolet B radiation is under clinical evaluation.

Symptomatic management with topical corticosteroids.

Topical mechlorethamine (nitrogen mustard). Topical application of mechlorethamine has produced regression of cutaneous lesions with particular efficacy in early stages of the disease. The overall complete remission rate is related to skin stage; 25% to 75% of TNM classification T2, and as many as 50% of T3 patients have complete responses. Treatments are usually continued for 2 to 3 years. [6] [9] [10] [11]

Local electron-beam radiation or orthovoltage radiation therapy may also be used to palliate areas of bulky or symptomatic disease.

Interferon-alpha alone or in combination with topical therapy, as evidenced in the ECOG-1495 trial. [12]

Bexarotene, an oral or topical retinoid. [13] [14]

Oral methotrexate. [15]

Pegylated liposomal doxorubicin. [16] [17]

Vorinostat, an oral histone deacetylase inhibitor. [18]

Current Clinical Trials

Check for U.S. clinical trials from NCI's list of cancer clinical trials that are now accepting patients with stage II mycosis fungoides/Sezary syndrome. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

References:

Stage III Mycosis Fungoides/Sézary Syndrome

No curative treatment exists for patients with stage III disease. The initial choice of palliative therapy is, therefore, dependent on the local expertise with each modality. In patients with the Sézary syndrome (SS), a high probability of extracutaneous involvement exists, and therefore systemic chemotherapy is often given, though no proof is available that this affects survival.

Treatment options (note that in this clinical setting, the skin is easily injured; any of the topical therapies must be administered with extreme caution): [2]

Psoralen and ultraviolet A radiation (PUVA). Therapeutic trials with PUVA have shown a 62% to 90% complete remission rate with early cutaneous stages achieving the best responses. PUVA may be used in conjunction with systemic treatment. Maintenance therapy with PUVA is generally required to prolong remission duration. [3] PUVA combined with interferon-alpha-2a is associated with a high response rate. [4]

TSEB. Electron radiation of appropriate energies will penetrate only to the dermis, and thus the skin alone can be treated without systemic effects. This therapy requires an excellent radiation therapy facility with physics support, considerable technical expertise, and precise dosimetry. The therapy can produce excellent palliation with complete response rates of as much as 80%. [5] [6]

Ultraviolet B radiation is under clinical evaluation.

Symptomatic management with topical corticosteroids.

Local electron-beam radiation or orthovoltage radiation therapy may also be used to palliate areas of bulky or symptomatic disease.

Fludarabine, 2-chlorodeoxyadenosine, and pentostatin are active agents for mycosis fungoides (MF) and SS. [7] [8] [9] [10]

Interferon-alpha alone or in combination with topical therapy, as evidenced in ECOG-1495. [8] [11]

Denileukin diftitox (interleukin-2 fusion toxin) for CD25 and MF. [12] [13]

Systemic chemotherapy (single agent or combination) often combined with treatment directed at the skin. [1] [14] [15]

Extracorporeal photochemotherapy. [16] [17] [18]

Topical mechlorethamine (nitrogen mustard). This form of treatment may be used palliatively or to supplement therapeutic approaches directed against nodal or visceral disease. The overall complete remission rate of TNM classification T4 patients is 20% to 40%. Treatments are usually continued for 2 to 3 years. [19] [20]

Bexarotene, an oral or topical retinoid. [21] [22]

Pegylated liposomal doxorubicin. [23] [24]

Vorinostat, an oral histone deacetylase inhibitor. [25]

Current Clinical Trials

Check for U.S. clinical trials from NCI's list of cancer clinical trials that are now accepting patients with stage III mycosis fungoides/Sezary syndrome. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

References:

Stage IV Mycosis Fungoides/Sézary Syndrome

The use of single alkylating agents has produced objective responses in 60% of patients with a duration of less than 6 months. One of the alkylating agents (e.g., mechlorethamine, cyclophosphamide, or chlorambucil), or the antimetabolite methotrexate is the most frequently used. Single agents have not been shown to cure any patients, and insufficient data exist to determine if these agents prolong survival. Combination chemotherapy is not definitely superior to single agents. Even in stage IV disease, treatments directed at the skin may provide significant palliation.

Treatment options: [2]

Psoralen and ultraviolet A radiation (PUVA). Therapeutic trials with PUVA have shown a 62% to 90% complete remission rate with early cutaneous stages achieving the best responses. PUVA may be used in conjunction with systemic treatment. Maintenance therapy with PUVA is generally required to prolong remission duration. [3] PUVA combined with interferon-alpha-2a is associated with a high response rate. [4]

TSEB. Electron radiation of appropriate energies will penetrate only to the dermis, and the skin alone can be treated without systemic effects. This therapy requires an excellent radiation therapy facility with physics support, considerable technical expertise, and precise dosimetry. This therapy can produce excellent palliation and may be combined with systemic treatment. [5]

Ultraviolet B radiation is under clinical evaluation.

Symptomatic management with topical corticosteroids.

Local electron-beam radiation or orthovoltage radiation therapy may also be used to palliate areas of bulky or symptomatic disease.

Fludarabine, 2-chlorodeoxyadenosine, and pentostatin are active agents for mycosis fungoides (MF) and Sézary syndrome. [6] [7] [8]

Interferon-alpha alone or in combination with topical therapy, as evidenced in the ECOG-1495 trial. [7] [9]

Denileukin diftitox (interleukin-2 fusion toxin) for CD25 and MF. [10] [11]

Systemic chemotherapy: chlorambucil plus prednisone, mechlorethamine, cyclophosphamide, methotrexate, and combination chemotherapy. [1] [12] [13]

Topical mechlorethamine (nitrogen mustard). This form of treatment may be used palliatively or to supplement therapeutic approaches directed against nodal or visceral disease. The overall complete remission rate in 243 patients was 64% and was related to stage; as many as 35% of stage IV patients had complete responses. Treatments are usually continued for 2 to 3 years. [14] [15]

Extracorporeal photochemotherapy alone [16] [17] [18] [19] or in combination with TSEB. [20]

Serotherapy with monoclonal antibodies. [21] [22]

Bexarotene, an oral or topical retinoid. [23] [24]

Pegylated liposomal doxorubicin. [25] [26]

Vorinostat, an oral histone deacetylase inhibitor. [27]

Current Clinical Trials

Check for U.S. clinical trials from NCI's list of cancer clinical trials that are now accepting patients with stage IV mycosis fungoides/Sezary syndrome. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

References:

Recurrent Mycosis Fungoides/Sézary Syndrome

The treatment of relapsed patients with cutaneous T-cell lymphomas involves the joint decisions of the dermatologist, medical oncologist, and radiation oncologist. It may be possible to re-treat localized areas of relapse in the skin with additional electron-beam radiation or possibly to repeat total-skin electron-beam radiation therapy (TSEB). [1] Photon radiation to bulky skin or nodal masses may prove beneficial. If these options are not possible, then continued topical treatment with other modalities such as mechlorethamine or psoralen and ultraviolet A radiation (PUVA) may be warranted to relieve cutaneous symptoms.

Clinical trials, if possible, should be considered as the next therapeutic option. Options under clinical evaluation include: [2]

Additional electron-beam radiation or a repeat of TSEB.
Photon radiation to bulky skin or nodal masses.
Topical treatment with mechlorethamine or PUVA.
PUVA combined with interferon-alpha-2a is associated with a high response rate. [3]
Ultraviolet B radiation.
Symptomatic management with topical corticosteroids.
Extracorporeal photochemotherapy has produced tumor regression in patients resistant to other therapies. [4] [5]
Radioimmunotherapy using an I-131-labeled monoclonal antibody directed against a T-cell antigen has produced brief responses in a clinical trial. [6]
The interleukin-2 fusion toxin, denileukin diftitox, is given monthly with response rates of about 30% to 40% for patients with CD25 and mycosis fungoides (MF). [7]
Bexarotene is a retinoid available in an oral or topical form with activity in patients with recurrent MF, as evidenced in the LIGAND-L1069-20 trial. [8] [9]
New purine nucleoside phosphorylase inhibitors such as peldesine. [10]
Allogeneic or autologous bone marrow transplantation. [11]

Current Clinical Trials

Check for U.S. clinical trials from NCI's list of cancer clinical trials that are now accepting patients with recurrent mycosis fungoides/Sezary syndrome. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

References:

Changes to This Summary (02/18/2010)

The PDQ cancer information summaries are reviewed regularly and updated as new information becomes available. This section describes the latest changes made to this summary as of the date above.

General Information

Added Arulogun et al. as reference 12.

Stage I Mycosis Fungoides/Sézary Syndrome

Added text to include ultraviolet B radiation is under clinical evaluation as the third standard treatment option and symptomatic management with topical corticosteroids as the fourth standard treatment option.

Added Olsen et al. as reference 19.

Stage II Mycosis Fungoides/Sézary Syndrome

Added Quereux et al. as reference 17 and Olsen et al. as reference 18.

Stage III Mycosis Fungoides/Sézary Syndrome

Added Scarisbrick et al. as reference 18, Quereux et al. as reference 24, and Olsen et al. as reference 25.

Stage IV Mycosis Fungoides/Sézary Syndrome

Added Scarisbrick et al. as reference 19, Quereux et al. as reference 26, and Olsen et al. as reference 27.

Recurrent Mycosis Fungoides/Sézary Syndrome

Added text to include additional electron-beam radiation or a repeat of total-skin electron-beam radiation therapy; photon radiation to bulky skin or nodal masses; topical treatment with mechlorethamine or psoralen and ultraviolet A radiation; ultraviolet B radiation and symptomatic management with topical corticosteroids as treatment options under clinical evaluation.

About This PDQ Summary

Purpose of This Summary

This PDQ cancer information summary for health professionals provides comprehensive, peer-reviewed, evidence-based information about the treatment of mycosis fungoides and the Sézary Syndrome. It is intended as a resource to inform and assist clinicians who care for cancer patients. It does not provide formal guidelines or recommendations for making health care decisions.

Reviewers and Updates

This summary is reviewed regularly and updated as necessary by the PDQ Adult Treatment Editorial Board. Board members review recently published articles each month to determine whether an article should:

be discussed at a meeting,
be cited with text, or
replace or update an existing article that is already cited.

Changes to the summaries are made through a consensus process in which Board members evaluate the strength of the evidence in the published articles and determine how the article should be included in the summary.

The lead reviewers for Mycosis Fungoides and the Sézary Syndrome Treatment are:

Barnett S. Kramer, MD (National Institutes of Health)
Eric J. Seifter, MD (Johns Hopkins University)

Any comments or questions about the summary content should be submitted to Cancer.gov through the Web site's Contact Form. Do not contact the individual Board Members with questions or comments about the summaries. Board members will not respond to individual inquiries.

Levels of Evidence

Some of the reference citations in this summary are accompanied by a level-of-evidence designation. These designations are intended to help readers assess the strength of the evidence supporting the use of specific interventions or approaches. The PDQ Adult Treatment Editorial Board uses a formal evidence ranking system in developing its level-of-evidence designations.

Permission to Use This Summary

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The preferred citation for this PDQ summary is:

National Cancer Institute: PDQ® Mycosis Fungoides and the Sézary Syndrome Treatment. Bethesda, MD: National Cancer Institute. Date last modified <MM/DD/YYYY>. Available at: http://cancer.gov/cancertopics/pdq/treatment/mycosisfungoides/HealthProfessional. Accessed <MM/DD/YYYY>.

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