PMID- 32547076 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220415 IS - 1178-6930 (Print) IS - 1178-6930 (Electronic) IS - 1178-6930 (Linking) VI - 13 DP - 2020 TI - Effectiveness and Safety of Apatinib in Patients with Advanced or Metastatic Adenocarcinoma of Stomach or Gastroesophageal Junction: A Prospective Observation Study. PG - 4457-4464 LID - 10.2147/OTT.S232287 [doi] AB - BACKGROUND: Apatinib showed promising efficacy in the treatment of advanced or metastatic gastric cancer (mGC) in previous clinical studies. However, the real-world data are limited, and this study aimed to assess the effectiveness and safety of apatinib for the treatment of advanced or mGC in this setting. METHODS: In this prospective observational study, progression-free survival (PFS), overall survival (OS), overall response rate (ORR), disease control rate (DCR) and treatment-related adverse events (AEs) were recorded and evaluated. Univariate and multivariate analyses were conducted to explore potential biomarkers which might be related to the effectiveness. RESULTS: A total of 321 mGC patients from 47 centers in China were enrolled between July 1, 2015, and March 1, 2018. Thirty-two patients achieved partial response, 155 patients achieved stable disease, and 115 patients had progressive disease, and no CR was achieved, illustrating an ORR of 10.60% and a DCR of 61.92%. The median PFS and OS were 4.0 and 8.2 months, respectively. Multivariate Cox analysis showed that the potential biomarkers associated with longer PFS were combination regimens plus taxel/docetaxel, and apatinib initial dosage >/=500mg, occurrence of AEs of leukopenia, and hand-foot syndrome. Main AEs were proteinuria (17.1%), hypertension (15.9%), and handfoot syndrome (8.7%). CONCLUSION: The present prospective observational study showed favorable effectiveness and safety of apatinib in real-world patients with advanced or metastatic GC in China. (A prospective, multi-center, non-intervention study of apatinib in the treatment of advanced gastric cancer-Trial Registry Number: ChiCTR-OPN-15006601). CI - (c) 2020 Shen et al. FAU - Shen, Bo AU - Shen B AD - Department of Oncology, Jiangsu Cancer Hospital and Jiangsu Institute of Cancer Research and The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, People's Republic of China. FAU - Jiang, Hua AU - Jiang H AD - Department of Oncology, Changzhou No. 2 People's Hospital, Changzhou, People's Republic of China. FAU - Wang, Lin AU - Wang L AD - Department of Oncology, Bayi Hospital of People's Liberation Army, Nanjing, People's Republic of China. FAU - Qian, Jun AU - Qian J AD - Department of Oncology, Suzhou Municipal Hospital, Suzhou, People's Republic of China. FAU - Shu, Yongqian AU - Shu Y AD - Department of Oncology, Jiangsu Province Hospital, Nanjing, People's Republic of China. FAU - Chen, Ping AU - Chen P AUID- ORCID: 0000-0002-8222-5347 AD - Department of Oncology, Yancheng City No. 1 People's Hospital, Yancheng, People's Republic of China. FAU - Mao, Guoxin AU - Mao G AD - Department of Oncology, Affiliated Hospital of Nantong University, Nantong, People's Republic of China. FAU - Liu, Baorui AU - Liu B AD - Department of Oncology, Nanjing Drum Tower Hospital, Nanjing, People's Republic of China. FAU - Zhang, Xizhi AU - Zhang X AD - Department of Oncology, Northern Jiangsu People's Hospital, Yangzhou, People's Republic of China. FAU - Liu, Chaoying AU - Liu C AD - Department of Oncology, Wuxi People's Hospital, Wuxi, People's Republic of China. FAU - Wu, Jun AU - Wu J AD - Department of Oncology, The First People's Hospital of Changzhou, Changzhou, People's Republic of China. FAU - Li, Xiaoqin AU - Li X AD - Department of Oncology, Affiliated Hospital of Jiangsu University, Zhenjiang, People's Republic of China. FAU - Cai, Wei AU - Cai W AD - Department of Oncology, The First People's Hospital of Wujiang, Wujiang, People's Republic of China. FAU - Shen, Wenxiang AU - Shen W AD - Department of Oncology, The First People's Hospital of Kunshan, Kunshan, People's Republic of China. FAU - Wang, Qiong AU - Wang Q AD - Department of Oncology, Jiangyin People's Hospital, Jiangyin, People's Republic of China. FAU - He, Jingdong AU - He J AD - Department of Oncology, Huai'an First People's Hospital, Huai'an, People's Republic of China. FAU - Hua, Dong AU - Hua D AD - Department of Oncology, Affiliated Hospital of Jiangnan University and Fourth People's Hospital of Wuxi, Wuxi, People's Republic of China. FAU - Zhang, Ziwen AU - Zhang Z AD - Department of Oncology, Changshu No. 2 People's Hospital, Changshu, People's Republic of China. FAU - Zhang, Youcheng AU - Zhang Y AD - Department of Oncology, Jiangning People's Hospital, Nanjing, People's Republic of China. FAU - Feng, Jifeng AU - Feng J AD - Department of Oncology, Jiangsu Cancer Hospital and Jiangsu Institute of Cancer Research and The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, People's Republic of China. LA - eng PT - Journal Article DEP - 20200520 PL - New Zealand TA - Onco Targets Ther JT - OncoTargets and therapy JID - 101514322 PMC - PMC7246318 OTO - NOTNLM OT - VEGFR2 inhibitor OT - apatinib OT - gastric cancer OT - non-intervention COIS- The authors declare no conflicts of interest in this work. EDAT- 2020/06/18 06:00 MHDA- 2020/06/18 06:01 PMCR- 2020/05/20 CRDT- 2020/06/18 06:00 PHST- 2019/09/24 00:00 [received] PHST- 2020/04/10 00:00 [accepted] PHST- 2020/06/18 06:00 [entrez] PHST- 2020/06/18 06:00 [pubmed] PHST- 2020/06/18 06:01 [medline] PHST- 2020/05/20 00:00 [pmc-release] AID - 232287 [pii] AID - 10.2147/OTT.S232287 [doi] PST - epublish SO - Onco Targets Ther. 2020 May 20;13:4457-4464. doi: 10.2147/OTT.S232287. eCollection 2020.