Randomized phase II trial of sorafenib alone or in

Authors: Anita Schwandt Vivian E von Gruenigen Robert M Wenham Heidi Frasure Susan Eaton Nancy Fusco Pingfu Fu John J Wright Afshin Dowlati Steven Waggoner

Publish Date: 2014/03/12

Volume: 32, Issue: 4, Pages: 729-738

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Abstract

Background/Purpose This study was designed to evaluate the response and toxicity of sorafenib alone or when combined with carboplatin and paclitaxel in patients with platinumsensitive recurrent ovarian cancer fallopian tube cancer or primary peritoneal cancer EOC Methods Patients with recurrent platinumsensitive EOC with no more than 2 prior courses of chemotherapy were randomized to singleagent sorafenib 400 mg twice daily or combination sorafenib 400 mg bid days 2–19 with IV carboplatin AUC 6 and IV paclitaxel 175 mg/m2 S+C/T every 3 weeks Single agent sorafenib could cross over to combination upon progression Results Patients were initially randomized to either arm however due to poor accrual sorafenib arm was prematurely closed A total of 13 patients were evaluable for response to sorafenib and 23 patients were evaluable for response to S+C/T Objective response rate RR was 15  for patients on sorafenib vs 61  for patients on S+C/T p = 0014 stable disease was seen in 62  and 35  respectively Clinical benefit rate CBR at 4 months mos was 69  for S and 65  for S+C/T The median progression free survival was 56 months on sorafenib vs 168 months on S+C/T p = 0012 and there was no significant difference of overall survival between two arms p = 0974 with median overall survival 256 months under sorafenib vs 259 months on S+C/T Patients remained on trial for a median of 78 cycles on sorafenib and 54 cycles on S+C/T Conclusion Sorafenib alone or in combination with carboplatin and paclitaxel has activity in patients with platinumsensitive EOC Sorafenib in combination with carboplatin and paclitaxel improved RR and PFS however there were increased grade and frequencies of toxicities

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