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

The effectiveness of nitrosourea fotemustine in treating malignant melanoma, which is an aggressive tumor of melanocytes, pigmented skin cells, was assessed in 169 afflicted patients. The cancer was disseminated throughout the body, including the brain. Nitrosourea fotemustine was given in a dose of 100 milligrams per square meter of body area by intravenous infusion over a one-hour period, every week for three weeks. This was followed by a rest period of four to five weeks. Therapy was maintained at the same dose every three weeks in patients who responded or were stabilized by initial treatment, until their disease progressed. Of 169 patients treated, 153 were assessed for complete response, as indicated by the elimination of the tumor. Treatment with nitrosourea fotemustine resulted in complete responses in three cases and partial responses in 34 patients, thereby producing a response rate of 24.2 percent. The response rates at specific sites were 25 percent within the brain; 19.2 percent in the viscera (or abdominal region); and 31.8 percent at nonvisceral sites. In most cases, the duration of response was 22 weeks, and the response rate in previously untreated patients was 30.7 percent. The main toxic effects of nitrosourea fotemustine were blood-related, and included leukopenia (an abnormal decrease in white blood cells) and thrombocytopenia (an abnormal decrease in platelets, cells involved in blood clotting). These findings suggest that nitrosourea fotemustine is effective and relatively safe in treating disseminated malignant melanoma. (Consumer Summary produced by Reliance Medical Information, Inc.)