DACARBAZINE AND INTERFERON-ALPHA FOR STAGE-IV MALIGNANT-MELANOMA

Based on encouraging reports of improved response rates with the use o f dacarbazine (DTIC) in combination with recombinant interferon alpha- 2a (rIFN-alpha-2a) in patients with metastatic malignant melanoma, we conducted a phase II study to determine the efficacy and feasibility o f this treatment regimen, 31 patients were treated with an induction d ose of rIFN-alpha-2a at 15 MIU/m(2) intravenously (IV) daily for 5 day s per week for 3 consecutive weeks followed by a continuous maintenanc e dose of 10 MIU/m(2) subcutaneously (SQ) given 3 days per week; start ing on day 22, in conjunction with rIFN-alpha-2a SQ, DTIC was started at a dose of 200 mg/m(2) IV for 5 continuous days completing a 28-day cycle, Therapy was continued until progression was evidenced, Of the 2 9 evaluable patients, 7 (24.1%) achieved an objective response (comple te plus partial remission) with the highest responses occurring in tho se patients assessed with pulmonary metastases. The median duration to treatment failure was 2.6 months, while the median survival was 6.9 m onths. Our data reveal that using rIFN-alpha-2a plus DTIC in combinati on does not yield better results than those achieved when using DTIC a lone. However, 3 of the 7 responders experienced long-term survival ra nging up to 42 months. Whether this benefit is achieved by the additio n of rIFN-alpha-2a can only be answered by large randomized clinical t rials. Conflicting results with some of the current literature are dis cussed.