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1. Lundin J, Hagberg H, Repp R, Cavallin-Ståhl E, Fredén S, Juliusson G, Rosenblad E, Tjønnfjord G, Wiklund T, Osterborg A: Phase 2 study of alemtuzumab (anti-CD52 monoclonal antibody) in patients with advanced mycosis fungoides/Sezary syndrome. Blood; 2003 Jun 1;101(11):4267-72
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  • [Title] Phase 2 study of alemtuzumab (anti-CD52 monoclonal antibody) in patients with advanced mycosis fungoides/Sezary syndrome.
  • This phase 2 study evaluated the safety and efficacy of alemtuzumab in 22 patients with advanced mycosis fungoides/Sézary syndrome (MF/SS).
  • Most patients had stage III or IV disease, reduced performance status, and severe itching.
  • Itching, self-assessed on a 0 to 10 visual analog scale, was reduced from a median of 8 before treatment to 2 at end of therapy.
  • Median time to treatment failure was 12 months (range, 5-32+ months).
  • [MeSH-major] Antibodies, Monoclonal / administration & dosage. Antibodies, Neoplasm / administration & dosage. Antineoplastic Agents / administration & dosage. Mycosis Fungoides / drug therapy. Sezary Syndrome / drug therapy
  • [MeSH-minor] Adult. Aged. Antibodies, Monoclonal, Humanized. Humans. Middle Aged. Opportunistic Infections / chemically induced. Pruritus / drug therapy. Remission Induction. Survival Analysis. Treatment Outcome

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  • (PMID = 12543862.001).
  • [ISSN] 0006-4971
  • [Journal-full-title] Blood
  • [ISO-abbreviation] Blood
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Humanized; 0 / Antibodies, Neoplasm; 0 / Antineoplastic Agents; 3A189DH42V / alemtuzumab
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2. Piekarz RL, Frye R, Turner M, Wright JJ, Allen SL, Kirschbaum MH, Zain J, Prince HM, Leonard JP, Geskin LJ, Reeder C, Joske D, Figg WD, Gardner ER, Steinberg SM, Jaffe ES, Stetler-Stevenson M, Lade S, Fojo AT, Bates SE: Phase II multi-institutional trial of the histone deacetylase inhibitor romidepsin as monotherapy for patients with cutaneous T-cell lymphoma. J Clin Oncol; 2009 Nov 10;27(32):5410-7
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  • [Title] Phase II multi-institutional trial of the histone deacetylase inhibitor romidepsin as monotherapy for patients with cutaneous T-cell lymphoma.
  • On the basis of observed responses in a phase I trial, a phase II trial of romidepsin in patients with T-cell lymphoma was initiated.
  • PATIENTS AND METHODS The initial cohort was limited to patients with cutaneous T-cell lymphoma (CTCL), or subtypes mycosis fungoides or Sézary syndrome, who had received no more than two prior cytotoxic regimens.
  • There were no limits on other types of therapy.
  • These patients had undergone a median of four prior treatments, and 62 patients (87%) had advanced-stage disease (stage IIB, n = 15; stage III, n= 6; or stage IV, n = 41).
  • [MeSH-major] Depsipeptides / therapeutic use. Histone Deacetylase Inhibitors / therapeutic use. Lymphoma, T-Cell, Cutaneous / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Antibiotics, Antineoplastic / adverse effects. Antibiotics, Antineoplastic / pharmacokinetics. Antibiotics, Antineoplastic / therapeutic use. Area Under Curve. Fatigue / chemically induced. Female. Humans. Leukemia / chemically induced. Male. Metabolic Clearance Rate. Middle Aged. Nausea / chemically induced. Thrombocytopenia / chemically induced. Treatment Outcome

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  • (PMID = 19826128.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / N01CO12400; United States / NCI NIH HHS / CO / N01-CO-12400; United States / Intramural NIH HHS / /
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, N.I.H., Intramural; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibiotics, Antineoplastic; 0 / Depsipeptides; 0 / Histone Deacetylase Inhibitors; CX3T89XQBK / romidepsin
  • [Other-IDs] NLM/ PMC2773225
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3. Marchi E, Alinari L, Tani M, Stefoni V, Pimpinelli N, Berti E, Pagano L, Bernengo MG, Zaja F, Rupoli S, Pileri S, Baccarani M, Zinzani PL: Gemcitabine as frontline treatment for cutaneous T-cell lymphoma: phase II study of 32 patients. Cancer; 2005 Dec 1;104(11):2437-41
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  • [Title] Gemcitabine as frontline treatment for cutaneous T-cell lymphoma: phase II study of 32 patients.
  • BACKGROUND: Based on the activity of gemcitabine in heavily pretreated patients with cutaneous T-cell lymphoma (CTCL), the objective of the current study was to determine the role of gemcitabine in the treatment of patients with advanced, untreated CTCL.
  • METHODS: Between June 2002 and February 2004, 32 untreated patients with mycosis fungoides (MF) (n = 26 patients); peripheral T-cell lymphoma, unspecified (PTCLU) with exclusive skin involvement (n = 5 patients); and Sezary syndrome (SS) (n = 1 patient) were enrolled in a 7-institution, Phase II trial and treated with gemcitabine.
  • This drug was given on Days 1, 8, and 15 of a 28-day schedule at a dose of 1200 mg/m2 intravenously over 30 minutes for a total of 6 cycles.
  • RESULTS: Of the 32 patients studied, 7 (22%) achieved a complete response (CR) and 17 (53%) achieved a partial response (PR), whereas the remaining 8 patients showed no benefit from the treatment.
  • Treatment appeared to be well tolerated; hematologic toxicity was mild and no nausea/emesis or organ toxicity was noted.
  • CONCLUSIONS: The results of the current Phase II study demonstrate the activity of gemcitabine as a single agent in untreated CTCL patients.
  • Further studies using gemcitabine in combination, either contemporary or sequentially, with other drugs in patients with advanced stage, untreated CTCL are needed.
  • [MeSH-major] Antimetabolites, Antineoplastic / therapeutic use. Antimetabolites, Antineoplastic / toxicity. Deoxycytidine / analogs & derivatives. Lymphoma, T-Cell, Cutaneous / drug therapy
  • [MeSH-minor] Adult. Aged. Female. Humans. Male. Middle Aged. Neoplasm Staging. Survival Analysis. Treatment Outcome

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  • (PMID = 16216001.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antimetabolites, Antineoplastic; 0W860991D6 / Deoxycytidine; B76N6SBZ8R / gemcitabine
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4. Marschalkó M, Kovács J, Somlai B, Berecz M, Hídvégi B, Hársing J, Désaknai M, Horváth A: [Interferon-alpha and PUVA therapy for mycosis fungoides]. Orv Hetil; 2001 Sep 16;142(37):2021-3
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  • [Title] [Interferon-alpha and PUVA therapy for mycosis fungoides].
  • [Transliterated title] Mycosis fungoides interferon-alfa- és PUVA-kezelése.
  • 14 patients suffering from early stage mycosis fungoides were treated with interferon alpha 2-a and PUVA/1 patient in stage I a, 3 patients in stage I b, 4 patients in stage II a and 6 patients in stage II b/during 3-21 months time course.
  • Interferon alpha 2-a was administered 3 times a week, in escalating dose from 3 MU to 9 MU, determining the individual maximal tolerated dose.
  • All of the patients responded well to the treatment.
  • Partial remission was observed after 4-13 weeks of treatment.
  • Total remission developed in 8 cases, after 8 weeks- 9 months of the treatment.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Immunologic Factors / therapeutic use. Interferon-alpha / therapeutic use. Mycosis Fungoides / drug therapy. PUVA Therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Aged. Female. Humans. Male. Middle Aged. Neoplasm Staging. Treatment Outcome

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  • (PMID = 11582733.001).
  • [ISSN] 0030-6002
  • [Journal-full-title] Orvosi hetilap
  • [ISO-abbreviation] Orv Hetil
  • [Language] hun
  • [Publication-type] English Abstract; Journal Article
  • [Publication-country] Hungary
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Immunologic Factors; 0 / Interferon-alpha
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5. Pulini S, Rupoli S, Goteri G, Pimpinelli N, Alterini R, Tassetti A, Scortechini AR, Offidani M, Mulattieri S, Stronati A, Brandozzi G, Giacchetti A, Mozzicafreddo G, Ricotti G, Filosa G, Bettacchi A, Simonacci M, Novelli N, Leoni P: Pegylated liposomal doxorubicin in the treatment of primary cutaneous T-cell lymphomas. Haematologica; 2007 May;92(5):686-9
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  • [Title] Pegylated liposomal doxorubicin in the treatment of primary cutaneous T-cell lymphomas.
  • Pegylated liposomal doxorubicin (Peg-Doxo) is a promising drug for advanced/recalcitrant primary cutaneous T-cell lymphomas (CTCLs).
  • This prospective phase II trial enrolled 19 patients.
  • We observed overall and complete response rates of 84.2% and 42.1% (with no significant differences between stage I-IIA and IIB-IV patients), and 11% grade III/IV toxicity.
  • Peg-Doxo seems to be an active and safe principle that should be used in plurirelapsed, early stage-MF and in combination with other chemotherapeutic agents in advanced and aggressive CTCLs.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Doxorubicin / analogs & derivatives. Lymphoma, T-Cell, Cutaneous / drug therapy. Polyethylene Glycols / therapeutic use
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Combined Modality Therapy. Disease-Free Survival. Female. Follow-Up Studies. Humans. Kaplan-Meier Estimate. Liposomes / administration & dosage. Male. Middle Aged. Mycosis Fungoides / drug therapy. Prospective Studies. Remission Induction. Salvage Therapy. Sezary Syndrome / drug therapy. Survival Analysis. Survival Rate. Treatment Outcome

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  • (PMID = 17488695.001).
  • [ISSN] 1592-8721
  • [Journal-full-title] Haematologica
  • [ISO-abbreviation] Haematologica
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] Italy
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Liposomes; 0 / liposomal doxorubicin; 30IQX730WE / Polyethylene Glycols; 80168379AG / Doxorubicin
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6. Dueck G, Chua N, Prasad A, Finch D, Stewart D, White D, van der Jagt R, Johnston J, Belch A, Reiman T: Interim report of a phase 2 clinical trial of lenalidomide for T-cell non-Hodgkin lymphoma. Cancer; 2010 Oct 1;116(19):4541-8
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  • BACKGROUND: Novel therapies are needed to improve outcomes in T-cell lymphomas.
  • METHODS: Patients with recurrent and refractory T-cell lymphomas other than mycosis fungoides and untreated patients ineligible for combination chemotherapy were prescribed oral lenalidomide (25 mg daily) on Days 1 to 21 of each 28-day cycle until disease progression, death, or unacceptable toxicity.
  • The 2-stage design allows for up to 40 patients.
  • RESULTS: At the time of this interim analysis, 24 patients were enrolled in this study, and 23 were evaluable for response.
  • Rash correlated with response to therapy (P=.003).
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Lymphoma, T-Cell / drug therapy. Thalidomide / analogs & derivatives
  • [MeSH-minor] Administration, Oral. Adult. Aged. Aged, 80 and over. Disease-Free Survival. Drug Resistance, Neoplasm. Female. Humans. Male. Middle Aged. Recurrence

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  • [Copyright] Copyright © 2010 American Cancer Society.
  • (PMID = 20572046.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 4Z8R6ORS6L / Thalidomide; F0P408N6V4 / lenalidomide
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7. Chiarion-Sileni V, Bononi A, Fornasa CV, Soraru M, Alaibac M, Ferrazzi E, Redelotti R, Peserico A, Monfardini S, Salvagno L: Phase II trial of interferon-alpha-2a plus psolaren with ultraviolet light A in patients with cutaneous T-cell lymphoma. Cancer; 2002 Aug 1;95(3):569-75
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  • [Title] Phase II trial of interferon-alpha-2a plus psolaren with ultraviolet light A in patients with cutaneous T-cell lymphoma.
  • PURPOSE: To evaluate the efficacy and side effects of psolaren with ultraviolet light A (PUVA) and interferon-alpha-2a (IFN-alpha-2a) in patients with mycosis fungoides (MF) and Sézary syndrome (SS).
  • PATIENTS AND METHODS: From May 1993 to January 1999, 63 symptomatic patients with all stages of MF and SS were treated in a prospective Phase II trial with systemic escalating doses of IFN-alpha-2a combined with PUVA for 1 year, followed by indefinite PUVA maintenance in complete responding patients.
  • RESULTS: Sixty-three patients were enrolled (Stage IA, n = 6; IB, n = 37; IIA, n = 3; IIB, n = 3; III, n = 12; IVA, n = 2).
  • Ten patients had received previous therapy.
  • Of 63 patients, 51 achieved a complete response (CR; 74.6%) or partial response (PR; 6%) to therapy.
  • Five patients stopped IFN-alpha-2a therapy due to toxicity.
  • Eighty-four percent of the patients received more than 75% of the planned dose (12 million units three times a week).
  • CONCLUSIONS: This combination of IFN-alpha-2a and phototherapy is an effective and safe therapy for patients with symptomatic MF.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Interferon-alpha / therapeutic use. Lymphoma, T-Cell, Cutaneous / drug therapy. PUVA Therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Combined Modality Therapy. Disease-Free Survival. Female. Humans. Male. Recombinant Proteins. Time Factors. Treatment Outcome

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  • [Copyright] Copyright 2002 American Cancer Society.
  • (PMID = 12209749.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interferon-alpha; 0 / Recombinant Proteins; 76543-88-9 / interferon alfa-2a
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8. Lundin J, Osterborg A: Therapy for mycosis fungoides. Curr Treat Options Oncol; 2004 Jun;5(3):203-14
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  • [Title] Therapy for mycosis fungoides.
  • Treatment of mycosis fungoides (MF) is indicated to reduce symptoms, improve clinical appearance, prevent secondary complications, and prevent progression of disease, all of which may have an impact on survival.
  • Treatment of MF includes topical and systemic therapies, which can be administered alone or in combination.
  • Psoralen and ultraviolet A radiation is effective in early-stage MF, inducing complete remissions in most patients.
  • Psoralen and ultraviolet A radiation may also be combined with low doses of interferon (IFN)-alpha to treat stage I/II disease.
  • However, early aggressive therapy with radiation and chemotherapy does not improve the prognosis.
  • Once the disease becomes refractory to topical therapy, IFN-alpha single-agent or combination chemotherapy may be administered, but the duration of response is often less than 1 year and ultimately all patients will relapse and become refractory.
  • Response rates after combined modality therapy with total skin electron beam irradiation and chemotherapy/IFN-alpha appear similar to response rates of chemotherapy alone.
  • Therefore, there is a great need for the further development of novel emerging treatment modalities, such as retinoids (ie, bexarotene) and immunotherapeutic agents (ie, cytokines, tumor vaccines, and monoclonal antibodies), all of which appear to have significant therapeutic potential in patients with MF.
  • Biologically based therapies may reduce the need for genotoxic therapies, such as cytostatics and radiotherapy.
  • [MeSH-major] Mycosis Fungoides / therapy. Skin Neoplasms / therapy
  • [MeSH-minor] Combined Modality Therapy. Ficusin / administration & dosage. Humans. Interferon-alpha / administration & dosage. Neoplasm Staging. Photosensitizing Agents / administration & dosage. Ultraviolet Therapy

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  • (PMID = 15115649.001).
  • [ISSN] 1527-2729
  • [Journal-full-title] Current treatment options in oncology
  • [ISO-abbreviation] Curr Treat Options Oncol
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Interferon-alpha; 0 / Photosensitizing Agents; KTZ7ZCN2EX / Ficusin
  • [Number-of-references] 50
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9. Abbott RA, Whittaker SJ, Morris SL, Russell-Jones R, Hung T, Bashir SJ, Scarisbrick JJ: Bexarotene therapy for mycosis fungoides and Sézary syndrome. Br J Dermatol; 2009 Jun;160(6):1299-307
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Bexarotene therapy for mycosis fungoides and Sézary syndrome.
  • BACKGROUND: Bexarotene (Targretin) is a synthetic retinoid which is licensed for the treatment of advanced refractory cutaneous T-cell lymphoma (CTCL).
  • METHODS: A retrospective study of 66 patients (44 male, 22 female) with mycosis fungoides (40 patients) or Sézary syndrome (26 patients) who were commenced on bexarotene prior to August 2007 was carried out.
  • Nineteen patients had early-stage (IB-IIA) refractory mycosis fungoides and 47 patients had advanced-stage CTCL (IIB-IVB).
  • RESULTS: Fifty-two out of 66 (79%) patients completed over 1 month of therapy with an intention-to-treat response rate of 44% (29/66).
  • Median time to maximal response was 3 months (1-9 months).
  • Median time to progression was 9 months (3-44 months).
  • Fourteen patients (21%) did not complete a month of bexarotene therapy.
  • Adverse effects of the whole group included central hypothyroidism in 100% (all grade II and managed with thyroid replacement) and hyperlipidaemia in 100% (all managed with lipid-lowering therapy +/- dose reduction).
  • Responses were seen in all stages and were higher in advanced stages: 26% (five of 19) with early-stage and 51% (24/47) of advanced-stage disease.
  • Twenty-eight out of 66 patients were treated with bexarotene monotherapy and the remainder were on one or more additional anti-CTCL therapies.
  • [MeSH-major] Anticarcinogenic Agents / therapeutic use. Mycosis Fungoides / drug therapy. Sezary Syndrome / drug therapy. Skin Neoplasms / drug therapy. Tetrahydronaphthalenes / therapeutic use
  • [MeSH-minor] Adult. Age Factors. Aged. Aged, 80 and over. Cohort Studies. Female. Humans. Male. Middle Aged. Retrospective Studies. Sex Factors. Treatment Outcome

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  • (PMID = 19222457.001).
  • [ISSN] 1365-2133
  • [Journal-full-title] The British journal of dermatology
  • [ISO-abbreviation] Br. J. Dermatol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Anticarcinogenic Agents; 0 / Tetrahydronaphthalenes; A61RXM4375 / bexarotene
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10. Di Lorenzo G, Di Trolio R, Delfino M, De Placido S: Pegylated liposomal doxorubicin in stage IVB mycosis fungoides. Br J Dermatol; 2005 Jul;153(1):183-5
Hazardous Substances Data Bank. DOXORUBICIN .

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  • [Title] Pegylated liposomal doxorubicin in stage IVB mycosis fungoides.
  • BACKGROUND: Previous studies have shown that pegylated liposomal doxorubicin (LD) is effective in the treatment of relapsing or recalcitrant cutaneous T-cell lymphoma.
  • OBJECTIVES: To evaluate the activity and toxicity of LD in patients with stage IVB mycosis fungoides (MF).
  • CONCLUSIONS: This study demonstrates that LD is beneficial in terms of activity and toxicity in stage IVB MF.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Doxorubicin / therapeutic use. Mycosis Fungoides / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Aged. Drug Evaluation. Female. Humans. Lung Neoplasms / radiography. Lung Neoplasms / secondary. Male. Middle Aged. Neoplasm Staging. Polyethylene Glycols. Retrospective Studies. Tomography, X-Ray Computed. Treatment Outcome

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  • (PMID = 16029347.001).
  • [ISSN] 0007-0963
  • [Journal-full-title] The British journal of dermatology
  • [ISO-abbreviation] Br. J. Dermatol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 30IQX730WE / Polyethylene Glycols; 80168379AG / Doxorubicin
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11. Lain T, Talpur R, Duvic M: Long-term control of mycosis fungoides of the hands with topical bexarotene. Int J Dermatol; 2003 Mar;42(3):238-41
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  • [Title] Long-term control of mycosis fungoides of the hands with topical bexarotene.
  • BACKGROUND: Limited Stage IA mycosis fungoides (MF) is often treated with topical steroids, which can cause atrophy, or with nitrogen mustard, which imposes several limitations on the patient's lifestyle.
  • Topical bexarotene is a novel synthetic rexinoid with few side-effects that has shown efficacy for treatment of mycosis fungoides skin lesions in recent Phase II-III clinical trials.
  • The Phase I-II trial involving 67 stage IA-IIA MF patients demonstrated complete response (CR) in 21% and partial response (PR) in 42% of the patients.
  • The median time to response was approximately 20 weeks.
  • In the phase III trial of refractory stage IA, IB and IIA MF, the patients demonstrated a 44% response rate (8% CR).
  • Patients with no prior therapy for mycosis fungoides responded at a higher rate (75%) than those with prior topical therapies.
  • METHODS: Case report of a patient with MF limited to the hands treated with topical bexarotene 0.1% gel in a open label phase II clinical trial.
  • RESULTS: Partial response occurred after 2 weeks of topical bexarotene therapy and the lesions were well controlled for 5 years using bexarotene monotherapy, with only occasional mild local irritation.
  • CONCLUSIONS: Topical bexarotene is effective as long-term treatment monotherapy for limited MF lesions.
  • To our knowledge this is the longest use of the drug by any individual.
  • [MeSH-major] Anticarcinogenic Agents / administration & dosage. Hand. Mycosis Fungoides / drug therapy. Skin Neoplasms / drug therapy. Tetrahydronaphthalenes / administration & dosage

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  • (PMID = 12653924.001).
  • [ISSN] 0011-9059
  • [Journal-full-title] International journal of dermatology
  • [ISO-abbreviation] Int. J. Dermatol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA16672-22; United States / NCI NIH HHS / CA / K24 CA86815; United States / NCI NIH HHS / CA / R21-CA74117
  • [Publication-type] Case Reports; Clinical Trial; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Anticarcinogenic Agents; 0 / Tetrahydronaphthalenes; A61RXM4375 / bexarotene
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12. Demierre MF, Vachon L, Ho V, Sutton L, Cato A, Leyland-Jones B: Phase 1/2 pilot study of methotrexate-laurocapram topical gel for the treatment of patients with early-stage mycosis fungoides. Arch Dermatol; 2003 May;139(5):624-8
Hazardous Substances Data Bank. LAUROCAPRAM .

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  • [Title] Phase 1/2 pilot study of methotrexate-laurocapram topical gel for the treatment of patients with early-stage mycosis fungoides.
  • OBJECTIVES: To assess the safety and tolerability of a topical gel formulation combining methotrexate and laurocapram and to obtain preliminary information on the therapeutic potential of methotrexate-laurocapram in patients with early-stage mycosis fungoides (stage IA or IB).
  • PATIENTS: Ten patients 18 years or older with histologically confirmed stage IA or IB mycosis fungoides.
  • Based on the investigator's global evaluation at the end of the treatment phase (week 24), 7 (78%) of 9 patients demonstrated a slight-to-moderate response to treatment with methotrexate-laurocapram.
  • This treatment may represent a new therapeutic potential for patients with mycosis fungoides.
  • [MeSH-major] Azepines / therapeutic use. Dermatologic Agents / therapeutic use. Methotrexate / therapeutic use. Mycosis Fungoides / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Administration, Topical. Adult. Aged. Drug Combinations. Female. Follow-Up Studies. Gels. Humans. Male. Middle Aged. Neoplasm Staging. Pilot Projects. Time Factors. Treatment Outcome

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  • (PMID = 12756099.001).
  • [ISSN] 0003-987X
  • [Journal-full-title] Archives of dermatology
  • [ISO-abbreviation] Arch Dermatol
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Azepines; 0 / Dermatologic Agents; 0 / Drug Combinations; 0 / Gels; 1F3X9DRV9X / laurocapram; YL5FZ2Y5U1 / Methotrexate
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13. Kennedy GA, Seymour JF, Wolf M, Januszewicz H, Davison J, McCormack C, Ryan G, Prince HM: Treatment of patients with advanced mycosis fungoides and Sézary syndrome with alemtuzumab. Eur J Haematol; 2003 Oct;71(4):250-6
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  • [Title] Treatment of patients with advanced mycosis fungoides and Sézary syndrome with alemtuzumab.
  • OBJECTIVES: Alemtuzumab (anti-CD52, Campath-1H) has recently been shown to be effective in the treatment of a range of hematological malignancies, including B-cell chronic lymphocytic leukemia and T-cell prolymphocytic leukemia.
  • We undertook a phase II study to evaluate the safety, tolerability and efficacy of alemtuzumab in patients with relapsed or refractory advanced stage cutaneous T-cell lymphoma.
  • PATIENTS AND METHODS: A total of eight patients were enrolled, seven with mycosis fungoides/Sézary syndrome (MF/SS) and one with large-cell transformation of MF.
  • Seven patients had disease refractory to multiple previous therapies.
  • Alemzumab (30 mg) was administered intravenously three times per week for 12 wk or until maximum response.
  • RESULTS: The overall response rate was 38%, with three patients achieving partial remission, two patients with stable disease and three patients with progressive disease (PD) during treatment.
  • The time to progression was short, with all patients developing PD within 4 months of starting alemtuzumab.
  • CONCLUSIONS: Our findings suggest that in heavily pretreated, refractory, advanced stage MF/SS, although alemtuzumab has biological activity, it is associated with significant toxicity and only modest clinical utility.
  • [MeSH-major] Antibodies, Monoclonal / therapeutic use. Antibodies, Neoplasm / therapeutic use. Antineoplastic Agents / therapeutic use. Antirheumatic Agents / therapeutic use. Mycosis Fungoides / drug therapy. Sezary Syndrome / drug therapy
  • [MeSH-minor] Adult. Antibodies, Monoclonal, Humanized. Disease Progression. Humans. Middle Aged. Remission Induction. Time Factors. Treatment Outcome

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  • (PMID = 12950233.001).
  • [ISSN] 0902-4441
  • [Journal-full-title] European journal of haematology
  • [ISO-abbreviation] Eur. J. Haematol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article
  • [Publication-country] Denmark
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Humanized; 0 / Antibodies, Neoplasm; 0 / Antineoplastic Agents; 0 / Antirheumatic Agents; 3A189DH42V / alemtuzumab
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14. Rupoli S, Goteri G, Pulini S, Filosa A, Tassetti A, Offidani M, Filosa G, Mozzicafreddo G, Giacchetti A, Brandozzi G, Cataldi I, Barulli S, Ranaldi R, Scortechini AR, Capretti R, Fabris G, Leoni P, Marche Regional Multicentric Study Group of Cutaneous Lymphomas: Long-term experience with low-dose interferon-alpha and PUVA in the management of early mycosis fungoides. Eur J Haematol; 2005 Aug;75(2):136-45
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  • [Title] Long-term experience with low-dose interferon-alpha and PUVA in the management of early mycosis fungoides.
  • OBJECTIVES: Combined high-dose Interferon-alpha and psoralen plus ultraviolet A irradiation (PUVA) have been reported to be effective in the treatment of early mycosis fungoides (MF); however, our study is the first controlled prospective study in the literature exploring the activity and tolerability of the combination with low dosages and evaluating further clinical outcome of early-MF patients.
  • METHODS: We carried out a multicentric prospective Phase II clinical study on 89 patients with early-stage IA to IIA MF treated for 14 months with low-dose IFN-alpha2b (6-18 MU/wk) and PUVA.
  • Treatment success was analysed in terms of freedom from treatment failure.
  • We think that our combination therapy can be considered an alternative approach compared with other modalities.
  • Good immunological host surveillance in the skin lesions seems to be an optimal basis for the therapeutic success.
  • [MeSH-major] Interferon-alpha / administration & dosage. Mycosis Fungoides / drug therapy. PUVA Therapy
  • [MeSH-minor] Aged. CD8-Positive T-Lymphocytes. Dendritic Cells. Female. Humans. Male. Middle Aged. Recurrence. Remission Induction. Skin / immunology. Skin / microbiology. Survival Analysis. Treatment Outcome

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  • [Copyright] Copyright Blackwell Munksgaard 2005.
  • (PMID = 16000130.001).
  • [ISSN] 0902-4441
  • [Journal-full-title] European journal of haematology
  • [ISO-abbreviation] Eur. J. Haematol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] Denmark
  • [Chemical-registry-number] 0 / Interferon-alpha
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15. Duvic M, Sherman ML, Wood GS, Kuzel TM, Olsen E, Foss F, Laliberté RJ, Ryan JL, Zonno K, Rook AH: A phase II open-label study of recombinant human interleukin-12 in patients with stage IA, IB, or IIA mycosis fungoides. J Am Acad Dermatol; 2006 Nov;55(5):807-13
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase II open-label study of recombinant human interleukin-12 in patients with stage IA, IB, or IIA mycosis fungoides.
  • BACKGROUND: Interleukin-12 (IL-12) increases Th(1) cytokines, natural killer (NK) cells, and cytotoxic T-cell activities.
  • Progression of mycosis fungoides is associated with Th(2) cytokines produced by a clonal proliferation of epidermotropic T-helper cells.
  • OBJECTIVE: To determine the safety and efficacy of subcutaneous recombinant human IL-12 (rhIL-12) in early mycosis fungoides (MF; stage IA-IIA) in a multi-center, open label clinical trial.
  • RESULTS: Twenty-three MF patients (stage IA, 12 patients; IB, 9; and IIA, 2) had previously received >3 therapies.
  • Twelve (52%) ultimately progressed with mean time to progressive disease of 57 days (range, 28-805).
  • Ten completed 6 months of therapy; 1 completed 24 months.
  • Of patients not completing 6 months of therapy, 6 progressed and 6 others discontinued because of adverse events or withdrew consent.
  • Seventeen patients had treatment-related adverse events that were generally mild or moderate in severity, including asthenia, headache, chills, fever, injection site reaction, pain, myalgia, arthralgia, elevated aspartate and alanine aminotransferase levels, anorexia, and sweating.
  • One patient in PR died of hemolytic anemia, possibly exacerbated by rhIL-12 treatment.
  • It was relatively well-tolerated in early-stage MF.
  • [MeSH-major] Adjuvants, Immunologic / therapeutic use. Interleukin-12 / therapeutic use. Mycosis Fungoides / drug therapy. Mycosis Fungoides / pathology. Skin Neoplasms / drug therapy. Skin Neoplasms / pathology
  • [MeSH-minor] Disease Progression. Drug Administration Schedule. Female. Humans. Injections, Subcutaneous. Male. Middle Aged. Neoplasm Staging. Recombinant Proteins / administration & dosage. Recombinant Proteins / adverse effects. Recombinant Proteins / therapeutic use. Treatment Outcome

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  • (PMID = 17052486.001).
  • [ISSN] 1097-6787
  • [Journal-full-title] Journal of the American Academy of Dermatology
  • [ISO-abbreviation] J. Am. Acad. Dermatol.
  • [Language] eng
  • [Grant] United States / NCRR NIH HHS / RR / M01RR00040
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Adjuvants, Immunologic; 0 / Recombinant Proteins; 187348-17-0 / Interleukin-12
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16. Roberge D, Muanza T, Blake G, Shustik C, Vuong T, Freeman CR: Does adjuvant alpha-interferon improve outcome when combined with total skin irradiation for mycosis fungoides? Br J Dermatol; 2007 Jan;156(1):57-61
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  • [Title] Does adjuvant alpha-interferon improve outcome when combined with total skin irradiation for mycosis fungoides?
  • BACKGROUND: Patients with mycosis fungoides (MF) experience frequent disease recurrences following total skin electron irradiation (TSEI) and may benefit from adjuvant therapy.
  • OBJECTIVES: To review the McGill experience with adjuvant alpha-interferon (IFN) in the treatment of MF.
  • Median TSEI dose was 35 Gy.
  • In the TSEI + IFN group, IFN was given subcutaneously at 3 x 10(6) units three times per week starting 2 weeks prior to start of TSEI, continued concurrently with the radiation and for an additional 12 months following TSEI.
  • Clinical stage was IA, IB, IIA, IIB, III and IVA in 2, 9, 4, 8, 1 and 7 patients of the TSEI group and 0, 3, 3, 7, 4 and 2 patients of the TSEI + IFN group.
  • All patients responded to treatment.
  • Acute grade II-III dermatitis was seen in all patients.
  • Even when controlling for disease stage, the addition of IFN did not appear to increase CR rate, disease-free survival or OS.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Interferon Type I / therapeutic use. Mycosis Fungoides / drug therapy. Mycosis Fungoides / radiotherapy. Skin Neoplasms / drug therapy. Skin Neoplasms / radiotherapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Chemotherapy, Adjuvant / methods. Cohort Studies. Combined Modality Therapy / methods. Disease-Free Survival. Drug Eruptions / etiology. Female. Humans. Male. Middle Aged. Neoplasm Recurrence, Local. Recombinant Proteins. Retrospective Studies. Treatment Outcome

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  • (PMID = 17199567.001).
  • [ISSN] 0007-0963
  • [Journal-full-title] The British journal of dermatology
  • [ISO-abbreviation] Br. J. Dermatol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interferon Type I; 0 / Recombinant Proteins
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17. Dueck GS, Chua N, Prasad A, Stewart D, White D, vanderJagt R, Johnston JB, Belch A, Reiman T: Activity of lenalidomide in a phase II trial for T-cell lymphoma: Report on the first 24 cases. J Clin Oncol; 2009 May 20;27(15_suppl):8524

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Activity of lenalidomide in a phase II trial for T-cell lymphoma: Report on the first 24 cases.
  • : 8524 Background: Novel therapies are needed to improve outcomes in T-cell lymphomas.
  • METHODS: Patients with relapsed and refractory T-cell lymphomas other than mycosis fungoides were prescribed oral lenalidomide (25mg daily) on days 1 to 21 of each 28 day cycle, with standardized dose reductions for toxicity.
  • Treatment continued until disease progression, death or unacceptable toxicity.
  • The two-stage design allows for up to 40 patients.
  • RESULTS: At the time of this interim analysis, 24 patients were enrolled in this study and 23 were evaluable for response.
  • Median number of prior therapies was 1 (range, 0-4), and three had prior autologous stem cell transplant.
  • Four patients were previously untreated and not candidates for combination chemotherapy.
  • Median time from completion of prior therapy to the start of lenalidomide was 8 months (range, 1-48 months).
  • The most common grade 3 adverse events were neutropenia (20.8%), febrile neutropenia (16.7%), and pain NOS (16.7%).

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  • (PMID = 27960899.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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18. El-Mofty M, El-Darouty M, Salonas M, Bosseila M, Sobeih S, Leheta T, Nada H, Tawdy A, Amin I, El-Enany G: Narrow band UVB (311 nm), psoralen UVB (311 nm) and PUVA therapy in the treatment of early-stage mycosis fungoides: a right-left comparative study. Photodermatol Photoimmunol Photomed; 2005 Dec;21(6):281-6
Hazardous Substances Data Bank. PSORALEN .

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  • [Title] Narrow band UVB (311 nm), psoralen UVB (311 nm) and PUVA therapy in the treatment of early-stage mycosis fungoides: a right-left comparative study.
  • BACKGROUND: Psoralen ultraviolet A (PUVA) is a widely used first-line therapy for treatment of early cutaneous T-cell lymphoma.
  • Narrow band UVB (UVB-NB) (311 nm) has been recently introduced as another effective line of treatment.
  • AIM: The aim of the present work was to compare the clinical and histopathologic efficacy of PUVA and UVB-NB in the treatment of early-stage MF (stages IA, IB and IIA), and to evaluate whether psoralen adds to the efficacy of UVB-NB or not.
  • PATIENTS AND METHODS: Twenty patients (stage IA, IB or IIA) were divided into two equal groups: group I received UVB-NB on the right body half vs. PUVA on the left side of the body for 48 sessions, and group II received PUVB-NB on the right side of the body vs. PUVA on the left side for 36 sessions.
  • The sessions were administered three times weekly.
  • RESULTS: In group I, almost equal results were obtained on both sides, i.e., UVB-NB and PUVA were equally effective in the treatment of early stages of MF, both clinically and histopathologically.
  • In group II, PUVB-NB was found to be as effective as conventional PUVA in the treatment of early-stage mycosis fungoides, also on both clinical and histopathological grounds.
  • CONCLUSION: UVB-NB phototherapy should be included among the initial therapeutic options of mycosis fungoides in view of its efficacy, convenience, and likelihood of fewer long-term adverse effects.
  • Addition of psoralen does not seem to enhance its therapeutic efficacy.
  • [MeSH-major] Ficusin / administration & dosage. Mycosis Fungoides / drug therapy. PUVA Therapy. Photosensitizing Agents / administration & dosage

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  • (PMID = 16313238.001).
  • [ISSN] 0905-4383
  • [Journal-full-title] Photodermatology, photoimmunology & photomedicine
  • [ISO-abbreviation] Photodermatol Photoimmunol Photomed
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article
  • [Publication-country] Denmark
  • [Chemical-registry-number] 0 / Photosensitizing Agents; KTZ7ZCN2EX / Ficusin
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19. Quereux G, Marques S, Nguyen JM, Bedane C, D'incan M, Dereure O, Puzenat E, Claudy A, Martin L, Joly P, Delaunay M, Beylot-Barry M, Vabres P, Celerier P, Sasolas B, Grange F, Khammari A, Dreno B: Prospective multicenter study of pegylated liposomal doxorubicin treatment in patients with advanced or refractory mycosis fungoides or Sézary syndrome. Arch Dermatol; 2008 Jun;144(6):727-33
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  • [Title] Prospective multicenter study of pegylated liposomal doxorubicin treatment in patients with advanced or refractory mycosis fungoides or Sézary syndrome.
  • PATIENTS: Twenty-five patients with either (1) stage II to stage IV CTCL previously unsuccessfully treated with at least 2 lines of treatments or (2) histologically transformed epidermotropic CTCL requiring chemotherapy.
  • MAIN OUTCOME MEASURES: The response to treatment was evaluated by clinical evaluation.
  • RESULTS: At the end of treatment, we observed an objective response (primary end point) in 56% of the patients (14 of 25): 5 complete responses and 9 partial responses.
  • The median overall survival time was 43.7 months.
  • For the 14 patients who experienced an objective response, the median progression-free survival time after the end of treatment was 5 months.
  • CONCLUSIONS: This prospective study demonstrates the effectiveness of Caelyx in treating CTCL, with an overall response rate of 56% in spite of the high proportion of patients with advanced-stage disease.
  • [MeSH-major] Doxorubicin / analogs & derivatives. Mycosis Fungoides / drug therapy. Polyethylene Glycols / therapeutic use. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Dose-Response Relationship, Drug. Female. Follow-Up Studies. Humans. Injections, Intravenous. Male. Middle Aged. Neoplasm Staging. Prospective Studies. Syndrome. Treatment Outcome

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  • [CommentIn] Arch Dermatol. 2008 Jun;144(6):786-7 [18559771.001]
  • (PMID = 18559761.001).
  • [ISSN] 1538-3652
  • [Journal-full-title] Archives of dermatology
  • [ISO-abbreviation] Arch Dermatol
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / liposomal doxorubicin; 30IQX730WE / Polyethylene Glycols; 80168379AG / Doxorubicin
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20. Wollina U, Looks A, Meyer J, Knopf B, Koch HJ, Liebold K, Hipler UC: Treatment of stage II cutaneous T-cell lymphoma with interferon alfa-2a and extracorporeal photochemotherapy: a prospective controlled trial. J Am Acad Dermatol; 2001 Feb;44(2):253-60
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  • [Title] Treatment of stage II cutaneous T-cell lymphoma with interferon alfa-2a and extracorporeal photochemotherapy: a prospective controlled trial.
  • However, no prospective trial has been published on the combination of both treatments, although retrospective investigations suggested a better efficacy than for either interferon or extracorporeal photochemotherapy.
  • Fourteen patients (all male) aged 38 to 72 years with CTCL of the mycosis fungoides type, stage IIa/IIb, and a 72-year-old male patient with a Ki-1 lymphoma were treated twice a month for 6 months with extracorporeal photochemotherapy using oral 8-methoxypsoralen as photosensitizer in combination with interferon alfa-2a subcutaneously 3 times a week in the maximal tolerable dosage (ie, up to 18 x 10(6) U).
  • In responders the time to best response was 4.3 +/- 1.4 months.
  • The sIL-2R levels did not change significantly during the first 4 months of treatment.
  • Among patients of stage IIa the response rate was 60% in contrast to only 25% of those in stage IIb.
  • There was no need for additional therapy, but interferon dose was decreased because of side effects.
  • After 1 year of follow-up the total response rate was 46.2% (6 of 13 patients): 5 of 9 with stage IIa(55.6%) and 1 of 4 with stage IIb (25.0%).
  • CONCLUSION: These results indicate that patients with CTCL stage IIa can achieve a total response rate of 56% with combined interferon alfa-2a and extracorporeal photochemotherapy.
  • Responders seem to experience their best response within the first 6 months of treatment.
  • The treatment is well tolerated and does not cause severe side effects.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Interferon-alpha / therapeutic use. Lymphoma, T-Cell, Cutaneous / drug therapy. PUVA Therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Administration, Oral. Adult. Aged. Humans. Injections, Subcutaneous. Male. Methoxsalen / administration & dosage. Middle Aged. Mycosis Fungoides / drug therapy. Mycosis Fungoides / pathology. Prospective Studies. Recombinant Proteins

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  • (PMID = 11174383.001).
  • [ISSN] 0190-9622
  • [Journal-full-title] Journal of the American Academy of Dermatology
  • [ISO-abbreviation] J. Am. Acad. Dermatol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Controlled Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interferon-alpha; 0 / Recombinant Proteins; 76543-88-9 / interferon alfa-2a; U4VJ29L7BQ / Methoxsalen
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21. Duvic M, Talpur R, Wen S, Kurzrock R, David CL, Apisarnthanarax N: Phase II evaluation of gemcitabine monotherapy for cutaneous T-cell lymphoma. Clin Lymphoma Myeloma; 2006 Jul;7(1):51-8
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II evaluation of gemcitabine monotherapy for cutaneous T-cell lymphoma.
  • PATIENTS AND METHODS: Twenty-five patients with CTCL on a phase II open-label trial and 8 patients off study received intravenous gemcitabine (1000 mg/m2) on day 1, 8, and 15 for > or = 6 cycles.
  • RESULTS: Two patients with CD30+ anaplastic large T-cell lymphoma and 31 with mycosis fungoides (stage IB [T2, n = 2], stage IIA [T2, n = 1], stage IIB [T3, n = 13], stage IVA [T3 N3, n = 3; T4b2, n = 2; T4b2 N3, n = 2], and stage IVB [T4b2 N1, n = 6; T4 N3b2 M1, n = 1; T3 N3 M1, n = 1]) had received a median of 5 previous therapies (range, 1-13 therapies).
  • Seven of 13 patients with mycosis fungoides (T3) responded, 10 had tumor burden reductions, and 8 of 11 patients with Sezary syndrome responded.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Deoxycytidine / analogs & derivatives. Lymphoma, T-Cell, Cutaneous / drug therapy. Sezary Syndrome / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Female. Humans. Infusions, Intravenous. Male. Middle Aged. Mycosis Fungoides / complications. Receptors, Interleukin-2 / blood. Treatment Outcome

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  • (PMID = 16879770.001).
  • [ISSN] 1557-9190
  • [Journal-full-title] Clinical lymphoma & myeloma
  • [ISO-abbreviation] Clin Lymphoma Myeloma
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA16672-22; United States / NCI NIH HHS / CA / K24 CA 86815
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Receptors, Interleukin-2; 0W860991D6 / Deoxycytidine; B76N6SBZ8R / gemcitabine
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22. Talpur R, Ward S, Apisarnthanarax N, Breuer-Mcham J, Duvic M: Optimizing bexarotene therapy for cutaneous T-cell lymphoma. J Am Acad Dermatol; 2002 Nov;47(5):672-84
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  • [Title] Optimizing bexarotene therapy for cutaneous T-cell lymphoma.
  • Statins (inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A reductase) may modulate class II major histocompatibility class expression and T-cell responses.
  • Thirteen had stage IA-IIA disease (RR = 53%, 1 complete response [CR]); 41 had stage IIB-IVB disease (RR = 46%, 2 CRs).
  • Sixteen patients with advanced disease treated with bexarotene (225-750 mg/d) in combination with other CTCL therapies achieved an overall RR of 69% (11/16) with concomitant statin therapy.
  • CONCLUSION: This single-center study supports the safety and efficacy of bexarotene as both a monotherapy and a combination therapy for CTCL.
  • When bexarotene is combined with other active CTCL therapies, higher RRs were achieved in patients with advanced disease, without unacceptable side effects.
  • [MeSH-major] Anticarcinogenic Agents / therapeutic use. Mycosis Fungoides / drug therapy. Skin Neoplasms / drug therapy. Tetrahydronaphthalenes / therapeutic use
  • [MeSH-minor] Algorithms. Dermatitis, Exfoliative / complications. Dermatitis, Exfoliative / therapy. Drug Therapy, Combination. Female. Humans. Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use. Hypertriglyceridemia / complications. Hypertriglyceridemia / drug therapy. Hypothyroidism / chemically induced. Middle Aged. Photopheresis. Prospective Studies. Treatment Outcome

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  • [CommentIn] J Am Acad Dermatol. 2004 Jun;50(6):e16; author reply e17 [15153920.001]
  • [CommentIn] J Am Acad Dermatol. 2004 Sep;51(3):482; author reply 482-3 [15338005.001]
  • (PMID = 12399758.001).
  • [ISSN] 0190-9622
  • [Journal-full-title] Journal of the American Academy of Dermatology
  • [ISO-abbreviation] J. Am. Acad. Dermatol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA16672-22; United States / NCI NIH HHS / CA / K24 CA 86815; United States / NCI NIH HHS / CA / R21-CA74117
  • [Publication-type] Case Reports; Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Anticarcinogenic Agents; 0 / Hydroxymethylglutaryl-CoA Reductase Inhibitors; 0 / Tetrahydronaphthalenes; A61RXM4375 / bexarotene
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23. Olsen EA, Kim YH, Kuzel TM, Pacheco TR, Foss FM, Parker S, Frankel SR, Chen C, Ricker JL, Arduino JM, Duvic M: Phase IIb multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous T-cell lymphoma. J Clin Oncol; 2007 Jul 20;25(21):3109-15
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  • [Title] Phase IIb multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous T-cell lymphoma.
  • PURPOSE: To evaluate the activity and safety of the histone deacetylase inhibitor vorinostat (suberoylanilide hydroxamic acid) in persistent, progressive, or recurrent mycosis fungoides or Sézary syndrome (MF/SS) cutaneous t-cell lymphoma (CTCL) subtypes.
  • PATIENTS AND METHODS: Patients with stage IB-IVA MF/SS were treated with 400 mg of oral vorinostat daily until disease progression or intolerable toxicity in this open-label phase IIb trial (NCT00091559).
  • Patients must have received at least two prior systemic therapies at least one of which included bexarotene unless intolerable.
  • The primary end point was the objective response rate (ORR) measured by the modified severity weighted assessment tool and secondary end points were time to response (TTR), time to progression (TTP), duration of response (DOR), and pruritus relief ( > or = 3-point improvement on a 10-point visual analog scale).
  • RESULTS: Seventy-four patients were enrolled, including 61 with at least stage IIB disease.
  • The ORR was 29.7% overall; 29.5% in stage IIB or higher patients.
  • Median TTR in stage IIB or higher patients was 56 days.
  • Median TTP was 4.9 months overall, and 9.8 months for stage IIB or higher responders.
  • The most common drug-related adverse experiences (AE) were diarrhea (49%), fatigue (46%), nausea (43%), and anorexia (26%); most were grade 2 or lower but those grade 3 or higher included fatigue (5%), pulmonary embolism (5%), thrombocytopenia (5%), and nausea (4%).
  • CONCLUSION: Oral vorinostat was effective in treatment refractory MF/SS with an acceptable safety profile.
  • [MeSH-major] Hydroxamic Acids / therapeutic use. Lymphoma, T-Cell, Cutaneous / drug therapy. Salvage Therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Administration, Oral. Adult. Aged. Aged, 80 and over. Confidence Intervals. Dose-Response Relationship, Drug. Drug Administration Schedule. Drug Resistance, Neoplasm. Female. Follow-Up Studies. Humans. Male. Maximum Tolerated Dose. Middle Aged. Neoplasm Staging. Probability. Survival Analysis. Treatment Outcome


24. Breneman D, Duvic M, Kuzel T, Yocum R, Truglia J, Stevens VJ: Phase 1 and 2 trial of bexarotene gel for skin-directed treatment of patients with cutaneous T-cell lymphoma. Arch Dermatol; 2002 Mar;138(3):325-32
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  • [Title] Phase 1 and 2 trial of bexarotene gel for skin-directed treatment of patients with cutaneous T-cell lymphoma.
  • OBJECTIVE: To evaluate the safety, dose tolerance, and efficacy of topical bexarotene gel in patients with early-stage cutaneous T-cell lymphoma (CTCL).
  • PARTICIPANTS: Sixty-seven adults with early-stage (TNM stages IA-IIA) CTCL.
  • INTERVENTIONS: Bexarotene gel, 0.1%, 0.5%, and 1.0%, applied in incremental dose adjustments from 0.1% gel every day to 1.0% gel 4 times daily or the maximal tolerated dose.
  • MAIN OUTCOME MEASURES: Patients were followed for efficacy and safety, and treatment continued as long as they benefited.
  • Adverse events were generally mild to moderate in severity and were confined to treatment sites.
  • Treatment-limiting toxic effects were associated with skin irritation and increased with gel exposure.
  • Median projected time to onset of response was 20.1 weeks (range, 4.0-86.0 weeks), and the estimated median response duration from the start of therapy was 99 weeks.
  • Patients with no previous therapy for mycosis fungoides responded at a higher rate (75%) than those who previously underwent topical therapies (67%).
  • CONCLUSIONS: Bexarotene gel was well tolerated, was easily self-applied, and had a substantial response rate in treating patients with early-stage CTCL.
  • [MeSH-major] Anticarcinogenic Agents / administration & dosage. Lymphoma, T-Cell / drug therapy. Skin Neoplasms / drug therapy. Tetrahydronaphthalenes / administration & dosage
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Female. Gels. Humans. Male. Middle Aged. Neoplasm Staging. Safety. Treatment Outcome

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  • [CommentIn] Arch Dermatol. 2002 Mar;138(3):398-9 [11902993.001]
  • [ErratumIn] Arch Dermatol 2002 Oct;138(10):1386
  • (PMID = 11902983.001).
  • [ISSN] 0003-987X
  • [Journal-full-title] Archives of dermatology
  • [ISO-abbreviation] Arch Dermatol
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Anticarcinogenic Agents; 0 / Gels; 0 / Tetrahydronaphthalenes; A61RXM4375 / bexarotene
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25. Duvic M, Olsen EA, Breneman D, Pacheco TR, Parker S, Vonderheid EC, Abuav R, Ricker JL, Rizvi S, Chen C, Boileau K, Gunchenko A, Sanz-Rodriguez C, Geskin LJ: Evaluation of the long-term tolerability and clinical benefit of vorinostat in patients with advanced cutaneous T-cell lymphoma. Clin Lymphoma Myeloma; 2009 Dec;9(6):412-6
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  • INTRODUCTION: Vorinostat, an orally active histone deacetylase inhibitor, was approved in October 2006 by the US Food and Drug Administration for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL) in patients with progressive, persistent, or recurrent disease during or after treatment with 2 systemic therapies.
  • PATIENTS AND METHODS: A multicenter, open-label phase IIb trial evaluated the activity and safety of vorinostat 400 mg orally daily in patients with > or = stage IB, persistent, progressive, or treatment-refractory mycosis fungoides or Sézary syndrome CTCL subtypes.
  • We report the safety and tolerability of long-term vorinostat therapy in patients who experienced clinical benefit in the previous phase IIb study.
  • RESULTS: As of December 11, 2008, 6 of 74 patients enrolled in the original study had received vorinostat for > or = 2 years: median age, 65 years; median number of previous therapies, 2.5; median time from diagnosis to enrollment, 1.8 years.
  • During the follow-up study, the most common drug-related grade 1-4 adverse events (AEs) were diarrhea, nausea, fatigue, and alopecia (6, 5, 4, and 3 patients, respectively).
  • Five patients have discontinued the study drug, and 1 patient is continuing therapy.
  • CONCLUSION: This post hoc subset analysis provides evidence for the long-term safety and clinical benefit of vorinostat in heavily pretreated patients with CTCL, regardless of previous treatment failures.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Histone Deacetylase Inhibitors / therapeutic use. Hydroxamic Acids / therapeutic use. Lymphoma, T-Cell, Cutaneous / drug therapy. Skin Neoplasms / drug therapy

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  • (PMID = 19951879.001).
  • [ISSN] 1938-0712
  • [Journal-full-title] Clinical lymphoma & myeloma
  • [ISO-abbreviation] Clin Lymphoma Myeloma
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Histone Deacetylase Inhibitors; 0 / Hydroxamic Acids; 58IFB293JI / vorinostat
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26. Ishihara K, Saida T, Otsuka F, Yamazaki N, Prognosis and Statistical Investigation Committee of the Japanese Skin Cancer Society: Statistical profiles of malignant melanoma and other skin cancers in Japan: 2007 update. Int J Clin Oncol; 2008 Feb;13(1):33-41
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  • Because the International Union Against Cancer (UICC) TNM and stage classifications for malignant melanoma were changed substantially in 2002, analyses in the present investigation were performed according to the new classifications.
  • In addition, the numbers of patients with various kinds of skin malignancies, including not only malignant melanoma but also basal cell carcinoma, squamous cell carcinoma, mycosis fungoides, actinic keratosis, Bowen's disease, and Paget's disease, registered at approximately 100 medical institutions in Japan from 1987 to 2001, were also investigated and data were tabulated.
  • The following results were obtained from the data for melanoma patients registered at major institutions from 1987 to 2001. (1) The overall 10-year survival rates for melanoma patients in each chronological group were ranked as: group C > B > A, although only the difference between groups C and A was statistically significant. (2) The male-to-female ratio ranged from 1: 0.97 to 1: 1.14, and the survival rate of female patients was higher than that of male patients (the 140-month survival rate was 70.6% in females and 60% in males). (3) Assessment of the age distribution showed that the number of patients increased rapidly from ages 40-49 years and reached a peak at around 60 years in all three groups. (4) The sole of the foot was the most common site of melanoma in both males and females, while melanomas on the lower limbs were also prevalent in females. (5) Acral lentiginous melanoma (ALM) was the most common type in all three groups, accounting for nearly 50% of the patients in each group.
  • The number of patients with superficial spreading melanoma (SSM) increased steadily over time and exceeded the number of patients with nodular melanoma (NM) in group C.
  • The prognosis of NM was the worst, while that of SSM was the most favorable. (6) The proportion of stage I patients was larger in group C than in groups A and B, but no significant difference among the groups was observed in the proportions of stage II, III, and IV patients.
  • For patients in stage III, the overall survival rate was higher in group C than that in group A or B, while there was no apparent difference in survival between the groups for patients in stage I or II.
  • For patients in stage IV, the survival rate in group C was slightly lower than that in group A or B. (7) In group C, the overall survival rates for substages III A, B, and C were ranked as III A > III B > III C. (8) The overall survival rates for stage IV M1a, M1b, and M1c were ranked as M1a > M1b > M1c.
  • In group C, the overall survival rate of stage IV patients with a normal serum lactic dehydrogenase (LDH) level was higher than that of patients with elevated LDH values. (9) Evaluation of the effects of some therapeutic procedures (prophylactic lymph node dissection and chemotherapy with and without interferon-beta) on the survivals of patients with melanoma was inconclusive and suggested the need for more studies in this area.
  • The prognosis of patients with advanced malignant melanoma remains extremely poor, but that of patients in stage III has shown an improvement.

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  • [Journal-full-title] International journal of clinical oncology
  • [ISO-abbreviation] Int. J. Clin. Oncol.
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