Pegylated liposomal doxorubicin and carboplatin (C-PLD) versus paclitaxel and carboplatin (C-P) in platinum-sensitive ovarian cancer (OC) patients (pts): Treatment at recurrence and overall survival (OS) final analysis from CALYPSO phase III GCIG trial.

5052 Background: CALYPSO is a large international randomized phase III trial comparing C-PLD and C-P in pts with OC in late relapse. Results of the progression-free survival (PFS), the primary endpoint, suggest a benefit in pts treated with C-PLD with a hazard ratio (HR) of 0.82 (P =.005). Overall severe non-hematologic toxicity (36.8% v 28.4%; P < .01) - including alopecia, neurotoxicity and carboplatin hypersensitivity leading to early discontinuation (15% v 6%; P < .001) - occurred more frequently in the C-P arm. Methods: From 04/05 to 10/07, 976 eligible pts were randomized to either C-P (carboplatin AUC 5 iv d1 + paclitaxel [P] 175 mg/m2 3h iv d1, q3w) or C-PLD (Carboplatin + PLD 30 mg/m2 iv d1 q4w) for at least 6 cycles. It was explored whether the treatment effect on PFS recently observed in CALYPSO was maintained after further treatment. OS of pts was analysed. Results: Median follow-up is 40 months (mo). 832 pts (86%) have progressed after CALYPSO treatment (C-PLD or C-P). At time of first progre...