Journal of Clinical Oncology, 2009 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 27, No 18S (June 20 Supplement), 2009: LBA5509
© 2009 American Society of Clinical Oncology

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Abstract

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)

GINECO, Paris, France; AGO-OVAR, Hamburg, Germany; NSGO, Oslo, Norway; ANZGOG, Sydney, Australia; NCIC-CTG, Vancouver, BC, Canada; ANZGOG, Queensland, Australia; AGO-Austria, Vienna, Austria; EORTC, Leuven, Belgium; MITO, Napoli, Italy; MANGO, Torino, Italy

LBA5509

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.

Abstract presentation from the 2009 ASCO Annual Meeting