Abstract

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 in late relapse is presented. While the primary endpoint of the study is PFS, the specific toxicity observed from these 2 regimens is critically important. Methods: From 4/05 to 10/07, 974 pts were recruited. Pts were randomized to either (C-P) ([C] AUC 5 iv d1 + [P] 175 mg/m2 iv d1, q3 wks) or (C-D) ([C] + PLD [D] 30 mg/m2 iv d1 q4 wks) for at least 6 cycles. Results: The data from the first 500 pts (C-D, n=251; C-P, n=249) were analyzed (Table). Median number of cycles received was 6 (1- 14) in two arms. Haematological toxicity contributed to more cycle delays in the CD (21%) than in the CP (14%) arm. Neutropenia & infection rates were similar in both arms. G-CSF was administered more frequently to pts in C-D arm (21%) than in C-P arm (15%). Grade (G) > 2 non-haematological toxicity was more frequent in the C-P arm. There were 104 (76 related) severe adverse events (SAE) in the C-P arm vs. 81 (44 related) in the C-D arm. Conclusions: This planned interim safety analysis on the first 500 patients confirmed different toxicity profiles in the two arms, with less drug-related SAE and less early therapy termination in the C-D arm. TOXICITY % Pts in C-D arm % Pts in C-P arm Anaemia G3–4 13 7 Thrombocytopenia G3–4 18 4 Alopecia G>2 9 85 Neuropathy G>2 3 29 Allergic reactions G>2 6 19 Arthralgia /myalgia G>2 4 20 Hand-foot syndrome G>2 13 2 Mucositis G>2 15 7 Early treatment termination (toxicity related) 6 14 No significant financial relationships to disclose.

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