Combination chemotherapy for alkylator-resistant ovarian carcinoma: a preliminary report of a Southwest Oncology Group trial.

The Southwest Oncology Group has carried out a phase III study of combination chemotherapy in patients with advanced epithelial ovarian cancer who had become resistant to prior drug treatment. Patients previously treated with only alkylating agents were given adriamycin-5-fluorouracil-hexamethylmelamine-cis-dichlorodiammineplatinum(II) combination. There have been 12 partial and two complete responses among 29 evaluable patients (at least one full treatment course) entered in this four-drug combination, for a 48% response rate. Two (7%) additional patients showed objective improvement. The median duration of response was 5.8 months. Ten (34%) of 29 patients have died. The median duration of survival was 12+ months. Patients who had previously received adriamycin plus alkylating agent therapy were treated with 5-fluorouracil-hexamethylmelamine-cis-dichlorodiammineplatinum(II). Only 23 (31%) of these 74 patients have had partial responses while an additional 7% have had objective "improvement"; 27 (36%) of these patients have died. The median duration of survival was 14 months. Both drug regimens were well-tolerated. There were no drug-related deaths. Although thrombocytopenia was dose-limiting in up to 40% of the patients, the mean lowest platelet counts in the four- and three-drug regimens were 116,000 and 123,000/mm3, respectively. There were no cases of serious azotemia (ie, BUN level greater than 40 mg/100 ml) or severe peripheral neuropathy.