RECOMBINANT INTERFERON ALPHA-2A IN COMBINATION WITH DACARBAZINE IN THE TREATMENT OF METASTATIC MALIGNANT-MELANOMA - ANALYSIS OF LONG-TERM RESPONDING PATIENTS

Thirty-four evaluable patients with metastatic malignant melanoma were entered into a phase-II study designed to assess the response rate an d analyze the long-term therapeutic efficacy of recombinant interferon (rIFN) alpha-2a and dacarbazine. Patients received 14 days of daily s ubcutaneous r-IFNalpha-2a (3 x 10(6) IU/day), followed by 9 x 10(6) IU on alternate days, as long as objective response lasted, in combinati on with i. v. dacarbazine started on day 7 (400 mg/m2) and repeated ev ery 21 days (dacarbazine doses were escalated to 800 mg/m2). In 11 pat ients, 6 complete (17.6%) and 5 partial (14.7%) responses were seen, w ith an overall response rate of 32.3% (95% confidence interval: 16%-48 %). The median survival time of the responding patients was significan tly better than that of patients with progressive disease (P = 0.01) a nd the median response time of the patients showing complete response was longer than that of the partially responding patients (14 and 7 mo nths respectively, P = 0.06).