Dacarbazine-vindesine versus dacarbazine-vindesine-cisplatin in disseminated malignant melanoma. A randomised phase III trial

Eur J Cancer. 1998 Aug;34(9):1368-74. doi: 10.1016/s0959-8049(98)00068-9.

Abstract

In a multicentre phase III study of disseminated malignant melanoma performed 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 intravenously (i.v.) at a dose of 250 mg/m2 days 1-5 every 4 weeks and V was given i.v. at a dose of 3.0 mg/m2 day 1 weekly. P was given i.v. at a dose of 100 mg/m2 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 containing P of which leucopenia, alopecia and nausea/vomiting were the most pronounced. The median time to progression was significantly longer in patients treated with DVP (4.2 versus 2.2 months, P = 0.007). In conclusion, adding P to DV did not change overall survival but did significantly increase toxicity.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Cisplatin / administration & dosage*
  • Cisplatin / adverse effects
  • Dacarbazine / administration & dosage
  • Dacarbazine / adverse effects
  • Female
  • Hematologic Diseases / chemically induced
  • Humans
  • Lung Neoplasms / secondary
  • Male
  • Melanoma / drug therapy*
  • Melanoma / secondary
  • Middle Aged
  • Nausea / chemically induced
  • Prospective Studies
  • Regression Analysis
  • Skin Neoplasms / drug therapy*
  • Survival Analysis
  • Treatment Outcome
  • Vindesine / administration & dosage
  • Vindesine / adverse effects
  • Vomiting / chemically induced

Substances

  • Dacarbazine
  • Cisplatin
  • Vindesine