Randomized phase III trial of vinblastine, bleomycin, and cis-dichlorodiammine-platinum versus dacarbazine in malignant melanoma.
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.
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D002986:Clinical Trials as Topic; D003606:Dacarbazine / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality; D008875:Middle Aged; D009059:Mouth Diseases / Q000139:chemically induced; D009503:Neutropenia / Q000139:chemically induced; D011897:Random Allocation; D018805:Sepsis / Q000139:chemically induced; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000401:mortality; D013921:Thrombocytopenia / Q000139:chemically induced; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects
D001761:Bleomycin; D014747:Vinblastine; D003606:Dacarbazine; D002945:Cisplatin