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The purpose of this study was to compare the response rate, overall and 1-year survival in patients with advanced melanoma treated with a standard therapy, dacarbazine and interferon-alpha (DTIC/IFN), or combination chemotherapy, consisting of dacarbazine, BCNU, cisplatin and tamoxifen (DBCT). Treatment toxicity and time spent in hospital were secondary end points. One hundred and five patients (of whom 100 were eligible) were randomized to receive either DTIC/IFN or DBCT. The trial was designed to detect a 25% absolute difference in response rate or in 1-year survival with 80% power. There was no significant difference in response rate: this was 17.3% with DTIC/IFN and 26.4% with DBCT. Median overall survival was similar at 199 and 202 days respectively. One-year survival rate favoured standard treatment (30.6 vs 22.6%), but did not differ significantly between arms. DBCT was associated with significantly greater haematological toxicity, and a greater need for time spent in hospital (5.75 days/treatment cycle vs 2.29 with dacarbazine and interferon). DBCT combination therapy cannot be recommended as standard treatment for advanced melanoma. Dacarbazine remains the standard chemotherapy for this condition.

Original publication

DOI

10.1054/bjoc.1999.1056

Type

Journal article

Journal

Br J Cancer

Publication Date

03/2000

Volume

82

Pages

1158 - 1162

Keywords

Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Carmustine, Cisplatin, Combined Modality Therapy, Dacarbazine, Disease Progression, Female, Humans, Interferon-alpha, Male, Melanoma, Middle Aged, Skin Neoplasms, Survival Analysis, Tamoxifen, Treatment Outcome