The Efficacy of Taxans in Combined Treatment of Ovarian Cancer

ABSTRACT Objective The efficacy of paclitaxel plus carboplatin (TC) or gemcitabine plus carboplatin (GC) induction regimens with or without paclitaxel consolidation therapy were assessed in ovarian cancer (OC). Methods Patients with stage T2NoMo- T3N1Mo were randomized to either GC (1 group) (gemcitabine 1,000 mg/m2), days 1 and 8, plus carboplatin area under the curve [AUC] 5, day 1 and TC (2 group) (paclitaxel 175 mg/m2) plus carboplatin AUC 6, day 1 every 21 days for up to six-eight cycles. Patients with complete response were allowed optional consolidation with paclitaxel 135 mg/m2 every 28 days for ≤ 12 months. Patients without complete response received single-agent crossover therapy at induction doses/schedules until complete response, disease progression, or unacceptable toxicity. Disease progression or death in 124 patients was required to compare induction arms with 80% statistical power for progression-free survival, the primary endpoint. Results Randomized induction therapy was received by 230 of 256 patients enrolled; 152 patients with complete response received paclitaxel consolidation whereas 56 patients without complete response received single-agent crossover therapy. Progression-free survival was similar for GC and TC (median, 19.0 and 21.3 months, respectively; P = 0.199). Despite high censoring rates (>50%), overall survival was longer for TC (median, 48.3 versus 43.8 months for GC; P = 0.011). Controlling for patient characteristics including performance status, residual tumor size, and tumor stage, there was no statistical difference in a multivariate analysis. Conclusions The regiment gemcitabine plus carboplatin does not improve progression-free survival over paclitaxel plus carboplatin as first-line induction chemotherapy in ovarian cancer. Although favouring paclitaxel plus carboplatin, overall survival analyses were limited by the study design and high censoring rates. Disclosure All authors have declared no conflicts of interest.