A phase II study of apatinib in patients with recurrent epithelial ovarian cancer

Objective. Antiangiogenic treatments have been implicated to play a major role in epithelial ovarian cancer (EOC). Apatinib, a novel oral antiangiogenic agent targeting vascular endothelial growth factor receptor (VEGFR2), is currently being studied in different tumor types and is already used in gastric adenocarcinoma. This study was performed to assess the efficacy and safety of apatinib in patients with recurrent, pretreated EOC. Patients and methods. Patients with recurrent, platinum-resistant, pre-treated EOC who failed available standard chemotherapy were enrolled. Apatinib was administered as 500 mg daily. Primary objective is the overall response rate (ORR) according to MASS criteria. Secondary objectives are progression free survival (PFS), overall survival (OS), disease control rate (DCR), safety and tolerability. The treatment duration is until disease progression or intolerability of apatinib. Results. 29 eligible patients were enrolled in this multicenter, open-label, single arm study and received apatinib for a median of 36.8 weeks (range 13-64.8 weeks). Median follow-up time was 12 months. 28 patients were eligible for efficacy analysis. ORR is 41.4% (95% confidence interval (CI), 233%-59.4%). DCR is 68.9% (95% CI, 52.1%-85.8%). Median PFS is 5.1 months (95% CI, 3.8 m-6.5 m). Median OS is 14.5 months (95% CI, 12.4 m-16.4 m). The most common treatment-related adverse events (AEs) were hand-foot syndrome (51.7%), hypertension (34.6%), nausea and vomiting (31.0%). 3 patients had no significant toxicity. 9 patients experienced grade 3 treatment-related AEs. Conclusions. Apatinib 500 mg daily p.o. is a feasible treatment in patients with recurrent, platinum-resistant, pretreated EOC. Multi-center prospective studies enrolling more patients are needed. (C) 2017 Elsevier Inc. All rights reserved.