Randomized trial of the addition of cis-platin (DDP) and/or BCG to cyclophosphamide (CTX) chemotherapy for ovarian carcinoma

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Abstract
A prospective randomized trial has compared cyclophosphamide (CTX) with CTX plus cis‐diamminodichloroplatinum (DDP) as the initital chemotherapy for advanced ovarian carcinoma. A secondary randomization compared the addition of BCG treatment to either chemotherapy. The addition of DDP had no measurable impact on survival, but a small survival trend favoring BCG‐treated patients was noted (P < 0.08). Toxicity from BCG treatment was insignificant, but the addition of DDP increased both early nausea and vomiting and later hematologic toxicity. There were three long‐term complete remission patients, and these all came from the group of six patients with pretreatment residual disease < 2 cm. A univariate analysis of pretreatment prognostic factors indicated significantly better prognosis (P < 0.02) for patients with no palpable tumor, platelet count < 400,000/mm3, residual tumor < 2 cm, resting pulse < 91/min. and LDH < 250 U/L. The authors conclude that for patients with large (> 2 cm) residual disease, there is no compelling evidence that initial combination therapy is superior to aggressive single alkylating agent treatment.