214 Fotemustine, dacarbazine (DTIC) and interferon α-2A (IFN) treatment of metastatic melanoma. Preliminary data

Purpose This phase II study was undertaken to define the toxicity and therapeutical activity of a Fotemustine-DTIC-IFN combination in patients (pts) with metastatic melanoma. Methods Treatment consisted of Fotemustine 100 mg/m 2 i.v. d 1, DTIC 250 mg/m 2 d 2–5 every 3 weeks. IFN 3 MUI was administered i.m. 3 times a week throughout the chemotherapy administration. Results At the time of this analysis (08–03–1995) 35 pts (20 M, 15 F; age range 24–75 years; 26 chemotherapy-naive; 26 with visceral or SNC involvement) have been treated for a total of 125 courses. Twenty-six pts are presently evaluable for response (3 non-eligible for major protocol violation, and 6 too early). One CR and 5 PR have been observed for a 23% ORR [95% C.I. 9–44]. The patient with CR had skin, lymph nodal and renal involvement at beginning of the treatment. Toxicity 32 pts are evaluable for toxicity for a total of 122 courses. The treatment has been generally well tolerated. Toxic deaths have not been registered Leucopenia and thrombocytopenia of grade 3–4 have been observed in only 2.5% and 6.5% of the total delivered courses respectively. Grade 3 anemia occurred in one patient. IFN-related fever occurred in 11.5% of the courses and was always mild. Conclusions Fotemustine–DTIC–IFN combination seems a well tolerated and quite effective treatment for patients with metastatic melanoma. Since we chose a 35% ORR as target activity level, and considered 20% ORR as the lowest level of interest, at least 7 responses in 31 evaluable pts are required in the first -stage of the trial to continue the accrual to a total of 53 pts.