A randomized trial of the combination of cis-platinum, oncovin and bleomycin (COB) versus methotrexate in patients with advanced squamous cell carcinoma of the head and neck.

A prospective randomized trial was conducted at Wayne State University, Detroit, Michigan, to compare the efficacy of the combination of high-dose cis-diamminodichloroplatinum, Oncovin (vincristine) and bleomycin (COB) to that of weekly methotrexate (MTX) in the induction and maintenance of remission in patients with previously treated advanced squamous cell carcinoma of the head and neck. Complete response (CR) was observed in 11.1% of patients treated with COB and in 8.3% of patients treated with weekly methotrexate. The overall response rate (PR + CR) was 33.3% to methotrexate versus 40.7% to COB. This difference was not significant, nor was the survival of patients treated by either modality. Important variables affecting survival in this study proved to be good performance status (greater than or equal to 70) and response to therapy. Nausea and vomiting were the more common side effects of COB (56%), while hematologic toxicity was more frequent and more severe in the methotrexate arm (75%). Combination chemotherapy with COB is not more effective in producing response or prolonging survival than weekly methotrexate in patients with advanced head and neck carcinoma when both regimens are compared in a randomized study.

RCT Entities:   Population Interventions Outcomes