Abstract
5527 Background: Belotecan is a camptothecin derivative with anti-tumor properties. Previous studies suggested the feasibility of belotecan-based chemotherapy for patients with primary or recurrent ovarian cancer. Thus, we conducted a phase IIb trial to compare the efficacy and safety between belotecan and another derivative of camptothecin, topotecan, in patients with recurrent or refractory ovarian cancer. Methods: Patients with recurrent or refractory ovarian cancer were randomized to receive belotecan 0.5 mg/m2 (B-arm) or topotecan 1.5 mg/m2(T-arm) intravenously for 5 consecutive days every 3 weeks till 6 cycles or disease progression. The primary endpoint was overall response rate based on RECIST or GCIG criteria, and secondary endpoints were progression-free survival (PFS), overall survival (OS) and adverse events according to NCI-CTCAE version 4.0. Results: One hundred and forty one patients were randomized from January 2011 to June 2014. Among all patients, 140 were eligible in full analysis (FA) ...
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