Prospective randomised multicentre clinical trial on the use of PUVA monotherapy versus PUVA plus interferon alfa 2a in patients with cutaneous T-Cell lymphoma

R. Stadler Prof a, J. Bohmeyer Dr. a, T. Luger Prof b, W. Sterry Prof c

a Department of Dermatology, Medical Centre Minden, Germany, b Department of Dermatology, University Münster, Germany, c Department of Dermatology, Charité Berlin, Germany

AIM: In the first European prospective multicentre trial we found high response rates in early CTCL stage I (87 % treated with IFN a 2a + PUVA). In stage II CTCL the rate of patients in complete remission was only 22 %. This data led to the question whether a combination therapy of IFN + PUVA is superior to a PUVA monotherapy. Methods: Patients with CTCL stages Ia to IIa were treated either with PUVA monotherapy or PUVA + IFN 2a. The randomisation for the trial was closed 31st January 2001. 131 patients from 25 departments of dermatology in Germany and Switzerland were enrolled in this trial. Diagnoses were confirmed by establishing T-cell receptor rearrangement. PUVA was performed to a maximum of 52 weeks with a follow-up-period of 12 months. In addition to PUVA patients in group B (combination therapy) received IFN a 2a at a dose of 9 mio IU three days a week subcutaneously. Results: 131 patients had been equally distributed into both treatment groups according to age, sex, and pre-treatment. Up to now results of 64 patients can be evaluated. The rate of complete remission was slightly, but not statistically significantly higher in the monotherapy group with 32 versus 28 patients. Up to this point there is a significant difference between both groups as duration of treatment until complete remission and duration of treatment until response are concerned. Time to achieve complete remission was 16 weeks in combination therapy group compared to 19.2 weeks in monotherapy group. More visible differences show cumulative UVA-dose were 144 J/cm² in the monotherapy group versus 98 J/cm² in the combination therapy group to achieve complete remission. Conclusion: This data represent a preliminary report. Not all data of the treatment protocol has been evaluated up to now. The response to treatment is achieved in shorter period of time in combination therapy group, treated with IFN a 2a + PUVA. The UVA-dose is significantly reduced in the group treated with combination; therefore side effects of PUVA are expected to be less with combination therapy.

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Paper presented at the International Symposium on Predictive Oncology and Intervention Strategies; Paris, France; February 9 - 12, 2002; in the section on Dietary Influences.