Phase II randomized trial of neoadjuvant (NA) chemotherapy (CT) with or without bevacizumab (Bev) in advanced epithelial ovarian cancer (EOC) (GEICO 1205/NOVA TRIAL).
2015
5531 Background: First-line carboplatin(C)-paclitaxel(P) and Bev has proved to be an active combination after primary debulking surgery and improved overall survival in suboptimal resected advanced EOC patients (pts). However, the role of Bev in the NA setting has not been well defined yet. Methods: We performed a phase II randomized open label multicentric study in 66 pts with high grade serous or endometroid EOC, FIGO stage III-IV, ECOG 0-2, considered unresectable in whom NA CT and interval debulking surgery (IDS) were planned. Main exclusion criteria were intestinal occlusion and contraindication for Bev therapy. Pts were randomized to four courses of triweekly C AUC 6 and P 175 mg/m2 iv alone or with at least 3 courses of bev 15 mg/kg i.v. every 3 w. in experimental arm. The primary endpoint was the complete macroscopic response rate at the time of IDS. Secondary objectives were safety, surgical feasibility, optimal surgery rate, RECIST 1.1 and GCIG response rate. Biomarker analysis were performed in...
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