DACARBAZINE-VINDESINE VERSUS DACARBAZINE-VINDESINE-CISPLATIN IN DISSEMINATED MALIGNANT-MELANOMA - A RANDOMIZED PHASE-III TRIAL

In a multicentre phase III study of disseminated malignant melanoma pe rformed in Sweden and Norway, 326 patients were randomised to receive treatment with the combination dacarbazine [DTIC] (D) and vindesine (V ) with or without the addition of cisplatin (P). D was given intraveno usly (i.v.) at a dose of 250 mg/m(2) days 1-5 every 4 weeks and V was given i.v. at a dose of 3.0 mg/m(2) day 1 weekly. P was given i.v. at a dose of 100 mg/m(2) day 1 every 4 weeks. There was no statistically significant difference in overall survival between the treatment arms (P = 0.22). Increased toxicity was observed in the treatment arm conta ining P of which leucopenia, alopecia and nausea/vomiting were the mos t pronounced. The median time to progression was significantly longer in patients treated with DVP (4.2 versus 2.2 months, P=0.007). In conc lusion, adding P to DV did not change overall survival but did signifi cantly increase toxicity. (C) 1998 Elsevier Science Ltd. All rights re served.