Purpose: A phase II-III randomised study to compare safety and efficacy of an oxaliplatin/cyclophosphamide (OXAC) combination, vs. the reference combination of cisplatin/cyclophosphamide (CPC), in untreated advanced ovarian cancer 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 (100 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 OXAC arm, were myelosuppression and vomiting, including (OXAC vs CPC, % patients): grade 3-4 leukopenia (37% vs. 56%), and anaemia (7% vs. 32%), with blood transfusions in 8% vs. 21%. In the OXAC arm, 64% of surgically assessable patients and 33% of clinically assessable patients achieved an objective response. In the CPC arm, 67% patients achieved a surgical response and 42% achieved an objective clinical response. In the OXAC and CPC arms, median progression free-survival was 13.0 and 13.3 months, and overall survival was 36.0 and 25.1 months respectively, without statistically significant difference. Conclusion: The activity and time-related parameters of the OXAC and CPC combinations in advanced ovarian cancer patients, are comparable. Combined with the better safety profile of the oxaliplatin-containing regimen, this confirms the interest of oxaliplatin combined with active new agents in this indication.
Multicenter phase II-III study of oxaliplatin plus cyclophosphamide vs. cisplatin plus cyclophosphamide in chemonaive advanced ovarian cancer patients / J. L., Misset; Ph, Vennin; P. H., Chollet; P., Pouillart; P. H., Laplaige; J. L., Frobert; D., Castera; M., Fabro; D., Langlois; Cortesi, Enrico; V., Lucas; E., Gamelin; A., Laadem; J., Otero. - In: ANNALS OF ONCOLOGY. - ISSN 0923-7534. - 12:10(2001), pp. 1411-1415. [10.1023/a:1012556627852]
Multicenter phase II-III study of oxaliplatin plus cyclophosphamide vs. cisplatin plus cyclophosphamide in chemonaive advanced ovarian cancer patients
CORTESI, Enrico;
2001
Abstract
Purpose: A phase II-III randomised study to compare safety and efficacy of an oxaliplatin/cyclophosphamide (OXAC) combination, vs. the reference combination of cisplatin/cyclophosphamide (CPC), in untreated advanced ovarian cancer 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 (100 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 OXAC arm, were myelosuppression and vomiting, including (OXAC vs CPC, % patients): grade 3-4 leukopenia (37% vs. 56%), and anaemia (7% vs. 32%), with blood transfusions in 8% vs. 21%. In the OXAC arm, 64% of surgically assessable patients and 33% of clinically assessable patients achieved an objective response. In the CPC arm, 67% patients achieved a surgical response and 42% achieved an objective clinical response. In the OXAC and CPC arms, median progression free-survival was 13.0 and 13.3 months, and overall survival was 36.0 and 25.1 months respectively, without statistically significant difference. Conclusion: The activity and time-related parameters of the OXAC and CPC combinations in advanced ovarian cancer patients, are comparable. Combined with the better safety profile of the oxaliplatin-containing regimen, this confirms the interest of oxaliplatin combined with active new agents in this indication.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.