FOTEMUSTINE AND INTERFERON-ALPHA-2B IN METASTATIC MALIGNANT-MELANOMA

The efficacy of treatment with fotemustine and interferon (IFN) alpha was evaluated in metastatic melanoma. A group of 50 patients with meta static malignant melanoma were treated with a combination of IFN alpha 2b and the nitrosourea fotemustine. The patients received 10 MU IFN t hree times weekly for 3 weeks and fotemustine at a dose of 100 mg/m(2) on days 8, 15 and 22. After a 5-week rest period, patients with stabi lized or responding disease received a maintenance therapy consisting of 10 MU IFN three times a week for 1 week followed by administration of fotemustine (100 mg/m(2)) on day 8. This cycle was repeated every 4 weeks until progression occurred. If there was complete remission (CR ), treatment was stopped after an additional three cycles. Toxicity an d clinical response were scored according to WHO criteria. Objective r esponse was seen in 14 patients (28%; 95% confidence interval 15.6%-40 .4%) with four CR and ten partial responses (PR). The median duration of CR was 73 weeks, that of PR 26 weeks. Toxicity was acceptable, enab ling treatment on an outpatient basis. The combination of fotemustine with IFN alpha is effective and well tolerated, but there is no eviden t advantage over fotemustine monotherapy in the treatment of metastati c melanoma.