A randomized, phase III study of carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in relapsed platinum-sensitive ovarian cancer (OC): CALYPSO study of the Gynecologic Cancer Intergroup (GCIG).
E. Pujade-Lauraine, S. Mahner, J. Kaern, V. Gebski, M. Heywood, P. Vasey, A. Reinthaller, I. Vergote, S. Pignata, A. Ferrero
Background: This multicenter phase III study was designed to compare efficacy and safety of carboplatin-pegylated liposomal doxorubicin (PLD) (C-D) and carboplatin-paclitaxel (C-P) in relapsed platinum-sensitive OC patients (pts).
Methods: Pts with recurrent OC > 6 months after first-line or second-line platinum-based therapy who had been pretreated with a taxane were randomized by stratified blocks to either C-D [C AUC 5 IV + PLD 30 mg/m2 IV] d1 q4 wk, or C-P [C AUC 5 IV + P 175 mg/m2 IV] d1 q3 wk x > 6 cycles. The primary endpoint was progression-free survival (PFS), with secondary endpoints of toxicity, QoL and survival. The non-inferiority design required 745 events with 90% power, 95% confidence interval (CI).
Results: From 4/05 to 09/07, 976 pts were enrolled, 467 to C-D arm and 509 to C-P arm. Pt parameters were well balanced. 85% of C-D and 78% of
C-P pts received > 6 cycles. Median follow-up is 21mo. Overall survival is still too early to be reported (n = 308 deaths). This is the final analysis for PFS and toxicity. Results are below.
Conclusions: This trial, the largest in relapsed OC, showed significant superiority of PLD-carboplatin combination in terms of PFS. In addition, compared to paclitaxel-carboplatin, PLD-carboplatin was well tolerated with lower rates of severe and long-lasting (neuropathy) toxicities.
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