Efficacy and safety of bexarotene combined with psoralen-ultraviolet A (PUVA) compared with PUVA treatment alone in stage IB-IIA mycosis fungoides: Final results from the EORTC Cutaneous Lymphoma Task Force phase III randomized clinical trial (NCT00056056)

British Journal of Dermatology

Volumn 167, Issue 3, 2012, Pages 678-687

  Whittaker, S ^a   Ortiz, P ^b   Dummer, R ^c   Ranki, A ^d   Hasan, B ^e   Meulemans, B ^e   Gellrich, S ^f   Knobler, R ^g   Stadler, R ^h   Karrasch, M ^e  

^a KING'S COLLEGE LONDON   (United Kingdom)

^b HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

^c UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^d HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^e EORTC DATA CENTER   (Belgium)

^f CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^g Universitatsklinik fur Dermatologie   (Austria)

^h KLINIKUM MINDEN   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

BEXAROTENE; METHOXSALEN;

ADULT; AGED; ANEMIA; ARTICLE; CHOLESTEROL BLOOD LEVEL; COMPARATIVE STUDY; CONTROLLED STUDY; DISEASE SEVERITY; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; FEMALE; HUMAN; HYPERTRIGLYCERIDEMIA; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; MYCOSIS FUNGOIDES; NEPHROTOXICITY; NEUTROPENIA; NEUTROPHIL COUNT; PHASE 3 CLINICAL TRIAL; PHOTOSENSITIVITY DISORDER; PRIORITY JOURNAL; PRURITUS; PUVA; RADIATION DOSE; RANDOMIZED CONTROLLED TRIAL; RASH; SIDE EFFECT; TREATMENT OUTCOME;

ADOLESCENT; ADULT; AGED; ANTICARCINOGENIC AGENTS; CHILD; CHILD, PRESCHOOL; COMBINED MODALITY THERAPY; DOSE-RESPONSE RELATIONSHIP, DRUG; DOSE-RESPONSE RELATIONSHIP, RADIATION; EARLY TERMINATION OF CLINICAL TRIALS; HUMANS; INFANT; METHOXSALEN; MIDDLE AGED; MYCOSIS FUNGOIDES; PHOTOSENSITIZING AGENTS; PUVA THERAPY; SKIN NEOPLASMS; TETRAHYDRONAPHTHALENES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84865611352     PISSN: 00070963     EISSN: 13652133     Source Type: Journal    
DOI: 10.1111/j.1365-2133.2012.11156.x     Document Type: Article

References (35)

1. Willemze R, Kerl H, Sterry W, et al. EORTC classification for primary cutaneous lymphomas: a proposal from the cutaneous lymphoma study group of the European Organisation for Research and Treatment of Cancer. Blood 1997; 90: 354-71. (Pubitemid 27276581)
2. Weinstock M, Horm J,. Mycosis fungoides in the United States: increasing incidence and descriptive epidemiology. JAMA 1988; 260: 42-6.
3. Bradford PT, Devessa SS, Anderson WF, Toro JR,. Cutaneous lymphoma incidence patterns in the United States: a population-based study of 3884 cases. Blood 2009; 113: 5064-73.
4. Bunn P, Lamberg S,. Report of the committee on staging and classification of cutaneous T-cell lymphomas. Cancer Treat Rep 1979; 63: 725-8. (Pubitemid 9217604)
5. Olsen E, Vonderheid E, Pimpinelli N, et al. Revisions to the staging and classification of mycosis fungoides and Sézary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the Cutaneous Lymphoma Task Force of the European Organization of Research and Treatment of Cancer (EORTC). Blood 2007; 110: 1713-22. (Pubitemid 47443880)
6. Olsen EA, Whittaker S, Kim YH, et al. Clinical end points and response criteria in mycosis fungoides and Sézary syndrome: a consensus statement of the International Society for Cutaneous Lymphomas, the United States Cutaneous Lymphoma Consortium, and the Cutaneous Lymphoma Task Force of the European Organisation for Research and Treatment of Cancer. J Clin Oncol 2011; 29: 2598-607.
7. Doorn R, Van Haselan C, Voorst Vader P, et al. Mycosis fungoides: disease evolution and prognosis of 309 Dutch patients. Arch Dermatol 2000; 136: 504-10. (Pubitemid 30212962)
8. Kim YH, Liu HL, Mraz-Gernhard S, et al. Long-term outcome of 525 patients with mycosis fungoides and Sézary syndrome: clinical prognostic factors and risk for disease progression. Arch Dermatol 2003; 139: 857-66. (Pubitemid 36898920)
9. Agar N, Wedgeworth E, Crichton S, et al. Survival outcomes and prognostic factors in mycosis fungoides/Sézary syndrome: a validation of the revised ISCL/EORTC proposal. J Clin Oncol 2010; 28: 4730-9.
10. Kaye F, Bunn P, Steinberg S, et al. A randomized trial comparing combination electron beam radiation and chemotherapy with topical therapy in the initial treatment of mycosis fungoides. N Engl J Med 1989; 321: 1748-90.
11. Hoppe R, Abel E, Deneau D, Price N,. Mycosis fungoides: management with topical nitrogen mustard. J Clin Oncol 1987; 5: 1796-803. (Pubitemid 18023396)
12. Ramsey D, Ed M, Halperin P, et al. Topical mechlorethamine therapy for early stage mycosis fungoides. J Am Acad Dermatol 1988; 19: 684-91.
13. Vonderheid E, Tan E, Kantor A, et al. Long term efficacy, curative potential and carcinogenicity of topical mechlorethamine chemotherapy in cutaneous T-cell lymphoma. J Am Acad Dermatol 1989; 20: 416-28. (Pubitemid 19086776)
14. Cotter G, Baglan R, Wasserman T, Mill W,. Palliative radiation treatment of cutaneous mycosis fungoides: a dose response. Int J Radiat Oncol Biol Phys 1983; 9: 1477-80. (Pubitemid 14227129)
15. Hermann J, Roenigk H, Hurria A, et al. Treatment of mycosis fungoides with photochemotherapy (PUVA): long term follow-up. J Am Acad Dermatol 1995; 33: 234-42.
16. Roenigk H, Kuzel T, Skoutelis A, et al. Photochemotherapy alone or combined with interferon alpha in the treatment of cutaneous T-cell lymphoma. J Invest Dermatol 1990; 95 (Suppl. 6): 198S-205S.
17. Honigsmann H, Brenner W, Rauschmeier W, et al. Photochemotherapy for cutaneous T cell lymphoma. A follow-up study. J Am Acad Dermatol 1984; 10: 238-45. (Pubitemid 14184182)
18. Querfeld C, Rosen ST, Kuzel TM, et al. Long-term follow-up of patients with early-stage cutaneous T-cell lymphoma who achieved complete remission with psoralen plus UV-A monotherapy. Arch Dermatol 2005; 141: 305-11. (Pubitemid 40365446)
19. Clark C, Dawe RS, Evans AT, et al. Narrowband TL-01 phototherapy for patch-stage mycosis fungoides. Arch Dermatol 2000; 136: 748-52. (Pubitemid 30407431)
20. Gathers RC, Scherschun L, Malick F, et al. Narrowband UVB phototherapy for early-stage mycosis fungoides. J Am Acad Dermatol 2002; 47: 191-7.
21. Ramsay DL, Lish KM, Yalowitz CB, Soter NA,. Ultraviolet-B phototherapy for early-stage cutaneous T-cell lymphoma. Arch Dermatol 1992; 128: 931-3.
22. Duvic M, Martin A, Kim Y, et al. Phase 2 and 3 clinical trial of oral bexarotene (Targretin capsules) for the treatment of refractory or persistent early stage cutaneous T-cell lymphoma. Arch Dermatol 2001; 137: 581-93. (Pubitemid 32458440)
23. Duvic M, Hymes K, Heald P, et al. Bexarotene is effective and safe for treatment of refractory advanced-stage cutaneous T-cell lymphoma: multinational phase II-III trial results. J Clin Oncol 2001; 19: 2456-71. (Pubitemid 32391217)
24. Gniadecki R, Assaf C, Bagot M, et al. The optimal use of bexarotene in cutaneous T-cell lymphoma. Br J Dermatol 2007; 157: 433-40. (Pubitemid 47256108)
25. Kaplan EL, Meier P,. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457-81.
26. Freedman LS, White SJ,. On the use of Pocock and Simon's method for balancing treatment numbers over prognostic factors in the controlled clinical trial. Biometrics 1976; 32: 691-4.
27. Schmid MH, Bird P, Dummer R, et al. Tumor burden index as a prognostic tool for cutaneous T-cell lymphoma: a new concept. Arch Dermatol 1999; 135: 1204-8. (Pubitemid 29493280)
28. Stadler R, Otte H, Luger T, et al. Prospective randomized multicenter clinical trial on the use of interferon alpha-2a plus acitretin versus interferon alpha-2a plus PUVA in patients with cutaneous T-cell lymphoma stages I and II. Blood 1998; 10: 3578-81. (Pubitemid 28525182)
29. Chiarion-Sileni V, Bononi A, Fornasa CV, et al. Phase II trial of interferon-alpha-2a plus psoralen with ultraviolet light A in patients with cutaneous T-cell lymphoma. Cancer 2002; 95: 569-75. (Pubitemid 34810182)
30. Kuzel TM, Roenigk HH Jr, Samuelson E, et al. Effectiveness of interferon alfa-2a combined with phototherapy for mycosis fungoides and the Sézary syndrome. J Clin Oncol 1995; 13: 257-63.
31. Rupoli S, Goteri G, Pulini S, et al. Long-term experience with low-dose interferon-alpha and PUVA in the management of early mycosis fungoides. Eur J Haematol 2005; 75: 136-45. (Pubitemid 41008284)
32. Stadler B, Luger T, Sterry W,. Prospective multicenter randomized clinical trial on the use of interferon alfa 2a plus PUVA versus PUVA monotherapy in patients with cutaneous T-cell lymphoma stages I and II. ASCO Annual Meeting Proceedings, Part 1. J Clin Oncol 2006; 24 (Suppl. 18s):abstr. 7541.
33. Singh F, Lebwohl MG,. Cutaneous T-cell lymphoma treatment using bexarotene and PUVA: a case series. J Am Acad Dermatol 2004; 51: 570-3. (Pubitemid 39278076)
34. Jones G, Hoppe R, Glatstein E,. Electron beam treatment for cutaneous T-cell lymphoma. Hematol Oncol Clin North Am 1995; 9: 1057-76.
35. Thomsen K, Hammar H, Molin L, et al. Retinoids plus PUVA (RePUVA) and PUVA in mycosis fungoides plaque stage. Acta Derm Venereol 1989; 69: 536-8.