Therapy of malignant melanoma with an imidazole carboxamide and bis-chloroethyl nitrosourea

Abstract

One hundred twelve evaluable patients with metastatic malignant melanoma were randomized to receive either a combination of DTIC 100 mg/m2/day × 5 days and BCNU 75 mg/m2/day × 2 days or DTIC 150 mg/m2/day × 5 days alone. The combination treatment yielded 12/61 responders as compared with 9/51 with DTIC alone. Responders survived significantly longer (7 months) than did nonresponders (3 months). Toxicity of both treatments was tolerable, but more frequent bone marrow suppression was encountered with DTIC-BCNU combination. Patients were analyzed for relation between survival and the following: regional node dissection, length of the free interval, and positive urinary melanogens. Only the latter relation tended to be positive. We conclude that DTIC is the best agent for the therapy of melanoma with an expected response rate of 20%, and that its combination with BCNU does not add to its therapeutic effectiveness except in patients with central nervous system metastases.