Final report of the french multicenter phase II study of the nitrosourea fotemustine in 153 evaluable patients with disseminated malignant melanoma including patients with cerebral metastases

Abstract

One hundred sixty‐nine patients with histologic evidence of disseminated malignant melanoma, including patients with cerebral metastases, were entered into a Phase II study of the nitrosourea fotemustine. The treatment regimen consisted of a 100 mg/m² 1 hour IV infusion every week for 3 consecutive weeks, followed by a 4‐ to 5‐week rest period (induction therapy). In responding or stabilized patients, maintenance therapy consisted of 100 mg/m² every 3 weeks until the disease progressed. One hundred fifty‐three patients were evaluable for response. Three complete responses and 34 partial responses were observed (according to the World Health Organization criteria), leading to an objective response rate of 24.2% (95% confidence interval: 17.4% to 31.0%). Responses were also documented on cerebral (25.0%), visceral (19.2%), or nonvisceral (31.8%) metastatic sites. The median duration of response was 22 weeks (range, 7 to 80 weeks). The objective response rate in previously untreated patients was 30.7% (19 of 62 patients). The main toxicity was hematologic with delayed and reversible leukopenia and/or thrombopenia. The objective response rate observed (especially in untreated patients), the activity on cerebral metastases, and the small amount of extra‐hematologic toxicity encountered suggest that fotemustine is an effective drug in disseminated malignant melanoma.