PMID- 32218807 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220413 IS - 1758-8340 (Print) IS - 1758-8359 (Electronic) IS - 1758-8340 (Linking) VI - 12 DP - 2020 TI - An open label, multicenter, noninterventional study of apatinib in advanced gastric cancer patients (AHEAD-G202). PG - 1758835920905424 LID - 10.1177/1758835920905424 [doi] LID - 1758835920905424 AB - BACKGROUND: Apatinib has been proved to be effective and well tolerated among patients in phase II and III studies. Here, we evaluated the safety and effectiveness of apatinib in advanced gastric cancer patients in a real-world setting. METHODS: This study enrolled advanced gastric cancer patients who had progressed or relapsed despite systemic chemotherapy. The primary outcome was safety and the secondary outcomes included overall survival (OS) and progression-free survival (PFS). RESULTS: A total of 337 patients were included. In total, 62 (18.4%), 102 (30.3%), and 173 (51.3%) patients received first, second, and third or higher line apatinib therapy, respectively. Grade 3/4 treatment-emergent adverse events (AEs) were infrequent (<5%), with hypertension (6.8%) being the only grade 3/4 AE occurring in more than 5% of the patients and across the low-dose (250 mg, 7.3%), mid-dose (425-500 mg, 6.1%), and high-dose group (675-850 mg, 2/15, 13.3%). The median OS and PFS were 7.13 months (95% CI, 6.17-7.93) and 4.20 months (95% CI, 4.60-4.77), respectively, and were comparable among the low-, mid-, and high-dose groups. CONCLUSION: Lower daily doses of apatinib achieved comparable OS and PFS versus higher daily doses of apatinib while maintaining a more benign safety profile in advanced gastric cancer patients. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02668380. CI - (c) The Author(s), 2020. FAU - Wang, Xiang AU - Wang X AD - Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China. FAU - Zhang, Ruixing AU - Zhang R AD - Department of Gastroenterology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China. FAU - Du, Nan AU - Du N AD - Department of Medical Oncology, Fourth Medical Center of PLA General Hospital, Beijing, China. FAU - Yang, Mudan AU - Yang M AD - Digestive Department of Oncology, Shanxi Tumor Hospital, Taiyuan, China. FAU - Zang, Aimin AU - Zang A AD - Department of Medical Oncology, Affiliated Hospital of Hebei University, Baoding, China. FAU - Liu, Likun AU - Liu L AD - Oncology Department, Shanxi Provincial Hospital of Traditional Chinese Medicine, Taiyuan, China. FAU - Yu, Junyan AU - Yu J AD - Department of Oncology, Peace Hospital of Changzhi Medical College, Changzhi, China. FAU - Gao, Jinghua AU - Gao J AD - Department of Medical Oncology, Cangzhou Central Hospital, Cangzhou, China. FAU - Zhang, Junping AU - Zhang J AD - Department of Medical Oncology, Shanxi Academy of Medical Sciences, Shanxi Dayi Hospital, Taiyuan, China. FAU - Fu, Zhanzhao AU - Fu Z AD - Department of Medical Oncology, First Hospital of Qinhuangdao, Qinhuangdao, China. FAU - Ren, Yuchuan AU - Ren Y AD - Oncology Department, Yangquan First People's Hospital, Yangquan, China. FAU - Ma, Liwen AU - Ma L AD - Department of Tumor Chemotherapy and Radiology, Peking University Third Hospital, Beijing, China. FAU - Guo, Jun AU - Guo J AD - Department of Medical Oncology, Xingtai People's Hospital, Hebei Medical University Affiliated Hospital, Xingtai, China. FAU - Li, Qingshan AU - Li Q AD - Department of Medical Oncology, Affiliated Hospital of Chengde Medical University, Chengde, China. FAU - Li, Xiaomei AU - Li X AD - Department of Medical Oncology, Chinese PLA General Hospital, Medical School of Chinese PLA, Beijing, China. FAU - Fan, Zaiwen AU - Fan Z AD - Department of Medical Oncology, Air Force General Hospital, PLA, Beijing, China. FAU - Song, Xiang AU - Song X AD - Department of Medical Oncology, Second Hospital of Shanxi Medical University, Taiyuan, China. FAU - Liu, Zheng AU - Liu Z AD - Department of Radiology, Handan Central Hospital, Handan, China. FAU - Zhang, Yan AU - Zhang Y AD - Department of Medical Oncology, Shijiazhuang People's Hospital, Shijiazhuang, China. FAU - Li, Guozhong AU - Li G AD - Department of Medical Oncology, Peking University Binhai Hospital, Tianjin, China. FAU - Yu, Zhonghe AU - Yu Z AD - Department of Medical Oncology, Seventh Medical Center of PLA General Hospital, Beijing, China. FAU - Diao, Jianfeng AU - Diao J AD - Department of Medical Oncology, Datong Second People's Hospital, Datong, China. FAU - Jia, Junmei AU - Jia J AD - Department of Medical Oncology, First Hospital of Shanxi Medical University, Taiyuan, China. FAU - Liang, Feng AU - Liang F AD - Department of General Surgery, Fifth Medical Center of PLA General Hospital, Beijing, China. FAU - Wang, Huaqing AU - Wang H AD - Department of Medical Oncology, Tianjin People's Hospital, Tianjin, China. FAU - Sun, Junzhong AU - Sun J AD - Department of Medical Oncology, Fourth Medical Center of PLA General Hospital, Beijing, China. FAU - Gao, Yunge AU - Gao Y AD - Department of Hematology and Oncology, Strategic Support Force Characteristic Medical Center/Former The 306 Hospital of PLA, Beijing, China. FAU - Yang, Ping AU - Yang P AD - Department of Medical Oncology, Sixth Medical Center of PLA General Hospital, Beijing, China. FAU - Bai, Chunmei AU - Bai C AUID- ORCID: 0000-0003-1333-9145 AD - Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, No.1 Shuaifuyuan Wangfujing Dongcheng District, Beijing 100032, China. FAU - Ren, Xiubao AU - Ren X AD - Department of Biotherapy, Tianjin Medical University Cancer Institute and Hospital, Tianjin 300060, China. FAU - Zhong, Diansheng AU - Zhong D AD - Department of Medical Oncology, Tianjin Medical University General Hospital, Tianjin 300052, China. LA - eng SI - ClinicalTrials.gov/NCT02668380 PT - Journal Article DEP - 20200319 PL - England TA - Ther Adv Med Oncol JT - Therapeutic advances in medical oncology JID - 101510808 PMC - PMC7082876 OTO - NOTNLM OT - apatinib OT - effectiveness OT - gastric cancer OT - real world OT - safety COIS- Conflict of interest statement: The authors declare that there is no conflict of interest. EDAT- 2020/03/29 06:00 MHDA- 2020/03/29 06:01 PMCR- 2020/03/19 CRDT- 2020/03/29 06:00 PHST- 2019/07/23 00:00 [received] PHST- 2020/01/14 00:00 [accepted] PHST- 2020/03/29 06:00 [entrez] PHST- 2020/03/29 06:00 [pubmed] PHST- 2020/03/29 06:01 [medline] PHST- 2020/03/19 00:00 [pmc-release] AID - 10.1177_1758835920905424 [pii] AID - 10.1177/1758835920905424 [doi] PST - epublish SO - Ther Adv Med Oncol. 2020 Mar 19;12:1758835920905424. doi: 10.1177/1758835920905424. eCollection 2020.