Multicenter phase II-III study of oxaliplatin plus cyclophosphamide vs. cisplatin plus cyclophosphamide in chemonaive advanced ovarian cancer patients

Purpose: A phase II-III randomised study to compare safety and efficacy of an oxaliplatin/cyclophosphamide (OXAC) combination, vs. the reference combi nation of cisplatin/cyclophosphamide (CPC), in untreated advanced ovarian c ancer patients. Patients and methods: 182 patients were enrolled, of whom 177 were treated; 86 with OXAC (130 mg/m(2) oxaliplatin two-hour intravenous (i.v.) infusion , 1000 mg/m(2) cyclophosphamide two-hour i.v. infusion), and 91 with CPC (1 00 mg/m(2) cisplatin one-hour i.v. infusion, 1000 mg/m(2) cyclophosphamide two-hour i.v. infusion). Treatment cycles were repeated every three weeks ( maximum of six cycles). Results: The main toxicities, which were significantly less severe in the O XAC arm, were myelosuppression and vomiting, including (OXAC vs CPC, % pati ents): grade 3-4 leukopenia (37% vs. 56%), and anaemia (7% vs. 32%), with b lood transfusions in 8% vs. 21%. In the OXAC arm, 64% of surgically assessa ble patients and 33% of clinically assessable patients achieved an objectiv e response. In the CPC arm, 67% patients achieved a surgical response and 4 2% achieved an objective clinical response. In the OXAC and CPC arms, media n progression free-survival was 13.0 and 13.3 months, and overall survival was 36.0 and 25.1 months respectively, without statistically significant di fference. Conclusion: The activity and time-related parameters of the OXAC and CPC co mbinations in advanced ovarian cancer patients, are comparable. Combined wi th the better safety profile of the oxaliplatin-containing regimen, this co nfirms the interest of oxaliplatin combined with active new agents in this indication.