Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer
September 1, 2003
Carboplatin/ Paclitaxel is non-inferior in PFS to cisplatin/paclitaxel in optimally resected, stage III epithelial ovarian cancer.
Cisplatin 75 mg/m2
Paclitaxel 135 mg/m2 over 24 hrs
q3 wks x6 cycles
Carboplatin AUC 7.5
Paclitaxel 175 mg/m2 over 3 hrs
q3wks x6 cycles
PFS (non-inferiority)
Stage III epithelial ovarian cancer
optimally cytoreduced (<1cm)
Carbo/paxlitaxel (n=392) vs Cisplatin/paclitaxel (n=400):
median PFS: 20.7 vs 19.4 mos (NS)
median OS: 57.4 vs 48.7 mos (NS)
Completion of 6 cycles: 87 % vs 85% (NS)
Carbo/taxol had less grade 3/4 leukopenia, GI, renal, metabolic toxicities than Cis/taxol but more thrombocytopenia (SS)
Carbo/paclitaxel is not inferior to cis/paclitaxel with regard to PFS in patients with optimally resected, stage III epithelial ovarian cancer.