PMID- 32441892 OWN - NLM STAT- MEDLINE DCOM- 20210513 LR - 20210513 IS - 2045-7634 (Electronic) IS - 2045-7634 (Linking) VI - 9 IP - 14 DP - 2020 Jul TI - Effectiveness and safety of low-dose apatinib in advanced gastric cancer: A real-world study. PG - 5008-5014 LID - 10.1002/cam4.3105 [doi] AB - Apatinib has been demonstrated to be effective and safe among patients with gastric cancer failing after at least two lines chemotherapy. This study aimed to evaluate its effectiveness and safety of low-dose apatinib for the treatment of gastric cancer in real-world practice. We performed a prospective, multicenter observation study in a real-world setting. Patients with advanced gastric cancer more than 18 years old were eligible and received low-dose apatinib (500 mg or 250mg per day) therapy. The median progression-free survival (PFS), median overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety were assessed. Between September 2017 and April 2019, a total of 747 patients were enrolled. The mPFS was 5.56 months (95% CI 4.47-6.28), and mOS was 7.5 months (95% CI 6.74-8.88). Four patients achieved complete response, 47 achieved partial response, and 374 patients achieved stable disease. The ORR was 6.83% and DCR was 56.89%. In addition, multivariate Cox regression analysis indicated that hand-foot syndrome was one independent predictor for PFS and OS. The most common adverse events (AEs) at any grade were hypertension (36.55%), proteinuria (10.26%), hand-foot syndrome (33.53%), fatigue (24.9%), anemia (57.35%), leukopenia (44.49%), thrombocytopenia (34.21%), and neutropenia (53.33%). Grade 3-4 AEs with incidences of 5% or greater were anemia (13.97%), thrombocytopenia (7.14%), and neutropenia (6.67%). No treatment-related death was observed during the treatment of apatinib. The prospective study suggested that low-dose apatinib was an effective regimen for the treatment of advanced gastric cancer with tolerable or controlled toxicity in real world. Trial registration: NCT03333967. CI - (c) 2020 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. FAU - Du, Yingying AU - Du Y AUID- ORCID: 0000-0002-5149-4632 AD - Department of Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China. FAU - Cao, Qisheng AU - Cao Q AD - Department of Interventional Oncology, People's Hospital of Ma'anshan, Ma'anshan, China. FAU - Jiang, Congqiao AU - Jiang C AD - Department of Gastrointestinal Surgery, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China. FAU - Liang, Hui AU - Liang H AD - Department of Tumor Radiotherapy, Lu'an Hospital of Traditional Chinese Medicine, Lu'an, China. FAU - Ning, Zhongliang AU - Ning Z AD - Department of Gastrointestinal Surgery, The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Cancer Hospital), Hefei, China. FAU - Ji, Chushu AU - Ji C AD - Department of Oncology, The First Affiliated Hospital of University of Science and Technology of China, Hefei, China. FAU - Wang, Jinguo AU - Wang J AD - Department of Gastrointestinal Surgery, Yijishan Hospital of WanNan Medical College, Wuhu, China. FAU - Zhou, Chaoping AU - Zhou C AD - Department of Surgical Oncology, Anqing Municipal Hospital, Anqing, China. FAU - Jiang, Zonghui AU - Jiang Z AD - Department of Oncology, The First People's Hospital of Chuzhou City, Chuzhou, China. FAU - Yu, Changjun AU - Yu C AD - Department of Gastrointestinal Surgery, The First Affiliated Hospital of Anhui Medical University, Hefei, China. FAU - Li, Lei AU - Li L AD - Department of Surgical Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China. FAU - Zhao, Yong AU - Zhao Y AD - Department of Oncology, Lu'an Hospital of Traditional Chinese Medicine, Lu'an, China. FAU - Xu, Yuemei AU - Xu Y AD - Department of Oncology, Jinzhai Country Hospital of Traditional Chinese Medicine, Lu'an, China. FAU - Xu, Tengyun AU - Xu T AD - Department of Oncology, The First Affiliated Hospital of University of Science and Technology of China, Hefei, China. FAU - Hu, Wenjun AU - Hu W AD - Department of Oncology, People's Hospital of Fuyang City, Fuyang, China. FAU - Wang, Daoqin AU - Wang D AD - Department of Gastrointestinal Surgery, Wanbei Coal-Electricity Group General Hospital, Suzhou, China. FAU - Cheng, Huaidong AU - Cheng H AD - Department of Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei, China. FAU - Wang, Guihe AU - Wang G AD - Department of Gastrointestinal Surgery, People's Hospital of Tongling City, Tongling, China. FAU - Zhou, Jinhua AU - Zhou J AD - Department of Oncology, The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, China. FAU - Wang, Song AU - Wang S AD - Department of Oncology, People's Hospital of Fuyang City, Fuyang, China. FAU - Zhang, Yanshun AU - Zhang Y AD - Department of Oncology, Huainan First People's Hospital, Huainan, China. FAU - Hu, Zhiqiang AU - Hu Z AD - Department of Oncology, Huaibei Miners General Hospital, Huaibei, China. FAU - Li, Xinzhong AU - Li X AD - Department of Oncology, The People's Hospital of Huaibei, Huaibei, China. FAU - Lu, Donghui AU - Lu D AD - Department of Oncology, The 901 Hospital of the Joint Logistic Support Force of the People's Liberation Army of China, Hefei, China. FAU - Zhang, Jun AU - Zhang J AD - Department of Oncology, The Second People's Hospital of Wuhu, Wuhu, China. FAU - Xie, Hua AU - Xie H AD - Department of Oncology, The People's Hospital of Xuancheng City, Xuancheng, China. FAU - Sun, Guoping AU - Sun G AUID- ORCID: 0000-0002-4325-900X AD - Department of Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China. LA - eng SI - ClinicalTrials.gov/NCT03333967 PT - Journal Article PT - Multicenter Study DEP - 20200522 PL - United States TA - Cancer Med JT - Cancer medicine JID - 101595310 RN - 0 (Pyridines) RN - 5S371K6132 (apatinib) SB - IM MH - Female MH - Humans MH - Male MH - Middle Aged MH - Progression-Free Survival MH - Prospective Studies MH - Pyridines/pharmacology/*therapeutic use MH - Stomach Neoplasms/*drug therapy/mortality PMC - PMC7367613 OTO - NOTNLM OT - advanced gastric cancer OT - apatinib OT - real-world COIS- All authors declare no potential conflict of interest. EDAT- 2020/05/23 06:00 MHDA- 2021/05/14 06:00 PMCR- 2020/05/22 CRDT- 2020/05/23 06:00 PHST- 2020/02/03 00:00 [received] PHST- 2020/03/23 00:00 [revised] PHST- 2020/04/15 00:00 [accepted] PHST- 2020/05/23 06:00 [pubmed] PHST- 2021/05/14 06:00 [medline] PHST- 2020/05/23 06:00 [entrez] PHST- 2020/05/22 00:00 [pmc-release] AID - CAM43105 [pii] AID - 10.1002/cam4.3105 [doi] PST - ppublish SO - Cancer Med. 2020 Jul;9(14):5008-5014. doi: 10.1002/cam4.3105. Epub 2020 May 22.