Randomized phase III trial of vinblastine, bleomycin, and cis-dichlorodiammine-platinum versus dacarbazine in malignant melanoma.

Abstract

A randomized phase III study was carried out in 57 patients with metastatic melanoma treated with either dacarbazine (DTIC) given intravenously (IV) daily for 10 days using light protection, or a combination of vinblastine IV on days 1 and 2, bleomycin by continuous IV infusion during days 1-5, and cisplatin by IV infusion on day 5 (VBD). Objective response rates were similar: 14% for dacarbazine and 10% for VBD. However, dacarbazine responses were associated with a trend toward longer progression-free intervals and longer survival. Toxicity was significantly greater in the VBD arm, and fatal in two patients. Dacarbazine was also associated with severe toxicity by the 10-day light-protected schedule used here. VBD is not as effective as previously reported, and dacarbazine remains a standard of therapy for metastatic melanoma.