Pegylated liposomal doxorubicin (PLD)-carboplatin (C) (C-D) vs paclitaxel-carboplatin (C-P) in relapsing sensitive ovarian cancer (OC): A 500-patient interim safety analysis of the CALYPSO GCIG Intergroup phase III study

摘要: 5565 Background: The preliminary results from the phase III study of carboplatin - PLD (C-D) vs Paclitaxel-Carboplatin (C-P) in patients (pts) with OC late relapse is presented. While primary endpoint PFS, specific toxicity observed these 2 regimens critically important. Methods: From 4/05 to 10/07, 974 pts were recruited. Pts randomized either ([C] AUC 5 iv d1 + [P] 175 mg/m2 d1, q3 wks) or [D] 30 q4 for at least 6 cycles. Results: data first 500 (C-D, n=251; C-P, n=249) analyzed (Table). Median number cycles received was (1- 14) two arms. Haematological contributed more cycle delays CD (21%) than CP (14%) arm. Neutropenia & infection rates similar both G-CSF administered frequently C-D arm C-P (15%). Grade (G) > non-haematological frequent There 104 (76 related) severe adve...