PMID- 29248198 OWN - NLM STAT- MEDLINE DCOM- 20180702 LR - 20220331 IS - 1095-6859 (Electronic) IS - 0090-8258 (Linking) VI - 148 IP - 2 DP - 2018 Feb TI - A phase II study of apatinib in patients with recurrent epithelial ovarian cancer. PG - 286-290 LID - S0090-8258(17)31596-2 [pii] LID - 10.1016/j.ygyno.2017.12.013 [doi] AB - 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 500mg 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 36.8weeks (range 13-64.8weeks). Median follow-up time was 12months. 28 patients were eligible for efficacy analysis. ORR is 41.4% (95% confidence interval (CI), 23.3%-59.4%). DCR is 68.9% (95% CI, 52.1%-85.8%). Median PFS is 5.1months (95% CI, 3.8m-6.5m). Median OS is 14.5months (95% CI, 12.4m-16.4m). 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 500mg daily p.o. is a feasible treatment in patients with recurrent, platinum-resistant, pretreated EOC. Multi-center prospective studies enrolling more patients are needed. CI - Copyright (c) 2017 Elsevier Inc. All rights reserved. FAU - Miao, Mingming AU - Miao M AD - Department of Gynecologic Oncology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, PR China. FAU - Deng, Guanming AU - Deng G AD - Department of Gynecologic Oncology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, PR China. FAU - Luo, Sujuan AU - Luo S AD - Department of Gynecologic Oncology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, PR China. FAU - Zhou, Jiajia AU - Zhou J AD - Department of Gynecologic Oncology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, PR China. FAU - Chen, Le AU - Chen L AD - Department of Gynecologic Oncology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, PR China. FAU - Yang, Jun AU - Yang J AD - Department of Gynecologic Oncology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, PR China. FAU - He, Jie AU - He J AD - Department of Gynecologic Oncology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, PR China. FAU - Li, Junjun AU - Li J AD - Department of Pathology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, PR China. FAU - Yao, Jing AU - Yao J AD - Department of Obstetric Gynecology, First People's Hospital of Loudi, Loudi, PR China. FAU - Tan, Shanmei AU - Tan S AD - Department of Obstetric Gynecology, First People's Hospital of Huaihua, Huaihua, PR China. FAU - Tang, Jie AU - Tang J AD - Department of Gynecologic Oncology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, PR China. Electronic address: tangjie@hnszlyy.com. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20171218 PL - United States TA - Gynecol Oncol JT - Gynecologic oncology JID - 0365304 RN - 0 (Angiogenesis Inhibitors) RN - 0 (Antineoplastic Agents) RN - 0 (Platinum Compounds) RN - 0 (Pyridines) RN - 5S371K6132 (apatinib) SB - IM MH - Angiogenesis Inhibitors/*administration & dosage/adverse effects MH - Antineoplastic Agents/*administration & dosage/adverse effects MH - Carcinoma, Ovarian Epithelial MH - Drug Resistance, Neoplasm MH - Feasibility Studies MH - Female MH - Humans MH - Kaplan-Meier Estimate MH - Middle Aged MH - Neoplasm Recurrence, Local/drug therapy MH - Neoplasms, Glandular and Epithelial/*drug therapy/mortality MH - Ovarian Neoplasms/*drug therapy/mortality MH - Platinum Compounds/therapeutic use MH - Prospective Studies MH - Pyridines/*administration & dosage/adverse effects MH - Treatment Outcome OTO - NOTNLM OT - Antiangiogenic treatment OT - Apatinib OT - Epithelial ovarian cancer OT - Platinum-resistant OT - Recurrence OT - Target therapy EDAT- 2017/12/19 06:00 MHDA- 2018/07/03 06:00 CRDT- 2017/12/18 06:00 PHST- 2017/10/14 00:00 [received] PHST- 2017/12/08 00:00 [revised] PHST- 2017/12/10 00:00 [accepted] PHST- 2017/12/19 06:00 [pubmed] PHST- 2018/07/03 06:00 [medline] PHST- 2017/12/18 06:00 [entrez] AID - S0090-8258(17)31596-2 [pii] AID - 10.1016/j.ygyno.2017.12.013 [doi] PST - ppublish SO - Gynecol Oncol. 2018 Feb;148(2):286-290. doi: 10.1016/j.ygyno.2017.12.013. Epub 2017 Dec 18.