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Safety and efficacy of apatinib in patients with advanced gastric or gastroesophageal junction adenocarcinoma after the failure of two or more lines of chemotherapy (AHEAD): a prospective, single-arm, multicenter, phase IV study

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机构： [1]Department of Oncology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China [2]Department of Oncology, Cancer Center of Jinling Hospital, Nanjing University of Chinese Medicine, No. 34 Biao, 34 Hao, Yanggongjing Road, Qinhuai District, Nanjing 210002, Jiangsu Province,China [3]Department of Gastroenterology, Shanxi Provincial Cancer Hospital, Taiyuan, China [4]Department of Internal Medicine, Anyang Cancer Hospital, Anyang, China [5]Department of Gastroenterology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China [6]Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China [7]Department of Oncology, ZiBo Central Hospital, Zibo, China [8]Department of Oncology, The Fourth Hospital of Hebei Medical University & Hebei Cancer Hospital, Shijiazhuang, China [9]Department of Oncology, Xinxiang Central Hospital, Xinxiang, China [10]Department of Oncology, The First Affiliated Hospital of USTC West District & Anhui Provincial Cancer Hospital, Hefei, China [11]Department of Digestive Oncology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin’s Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, China [12]Department of Medical Oncology, Zhejiang Cancer Hospital, Institute of Cancer and Basic Medicine, Chinese Academy of Sciences, Cancer Hospital of the University of Chinese Academy of Sciences, Hangzhou, China [13]Department of Medical Oncology, Fujian Medical University Affiliated Union Hospital, Fuzhou, China [14]Department of Abdominal Oncology, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Fuzhou, China [15]Department of Oncology, Changzhi People’s Hospital, Changzhi, China [16]Department of Oncology, Harbin Medical University Cancer Hospital, Harbin, China [17]Department of Oncology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China [18]Department of Oncology, Heilongjiang Agricultural Reclamation Bureau General Hospital, Harbin, China [19]Department of Radiotherapy and Chemotherapy, Tangshan People’s Hospital, Tangshan, China [20]Department of Digestive Oncology, Baotou Tumor Hospital, Baotou, China [21]Department of Oncology, The First Affiliated Hospital of Xiamen University, Xiamen, China [22]Department of Oncology, Jiangyin People’s Hospital, Jiangyin, China [23]Department of Oncology, The Affiliated Hospital of Guangdong Medical University, Zhanjiang, China [24]Department of Oncology, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, Xiangyang, China [25]Department of Oncology, The Second People’s Hospital of Hefei, Hefei, China [26]Department of Oncology, Weifang People’s Hospital, Weifang, China [27]Department of Oncology, 105 Hospital of People’s Liberation Army, Hefei, China [28]Department of Oncology, The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, China [29]Department of Oncology, The First Hospital of Jilin University, Changchun, China [30]Department of Oncology, Shanxi Traditional Chinese Medical Hospital, Taiyuan, China [31]Department of Oncology, Central Hospital Affiliated To Shandong First Medical University, Jinan, China [32]Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.

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关键词： Advanced gastric cancer Apatinib Third- and later-line treatment Phase IV study Safety Efficacy

摘要：

Apatinib, a highly selective VEGFR2 inhibitor, significantly improved efficacy versus placebo as a third- and later-line treatment for advanced gastric cancer in phase 2 and 3 trials. This prospective, single-arm, multicenter phase IV AHEAD study was conducted to verify the safety and efficacy of apatinib in patients with advanced or metastatic gastric or gastroesophageal adenocarcinoma after at least two lines of systematic therapy in clinical practice settings.Patients with advanced gastric cancer who had previously failed at least two lines of chemotherapy received oral apatinib until disease progression, death or unacceptable toxicity. The primary endpoint was safety. The secondary endpoints included objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS). Adverse events were summarized by the incidence rate. Median OS and PFS were estimated using the Kaplan-Meier method. ORR, DCR, OS at 3 and 6 months, and PFS at 3 and 6 months were calculated, and their 95% CIs were estimated according to the Clopper-Pearson method.Between May 2015 and November 2019, a total of 2004 patients were enrolled, and 1999 patients who received at least one dose of apatinib were assessed for safety. In the safety population, 87.9% of patients experienced treatment-related adverse events (TRAEs), with the most common hypertension (45.2%), proteinuria (26.5%), and white blood cell count decreased (25.3%). Additionally, 51% of patients experienced grade ≥ 3 TRAEs. Fatal TRAEs occurred in 57 (2.9%) patients. No new safety concerns were reported. Among the 2004 patients included in the intention-to-treat population, the ORR was 4.4% (95% CI, 3.6-5.4%), and DCR was 35.8% (95% CI, 33.7-38.0%). The median PFS was 2.7 months (95% CI 2.2-2.8), and the median OS was 5.8 months (95% CI 5.4-6.1).The findings in the AHEAD study confirmed the acceptable and manageable safety profile and clinical benefit of apatinib in patients with advanced gastric cancer as a third- or later-line of treatment.This study was registered with ClinicalTrials.gov NCT02426034. Registration date was April 24, 2015.© 2023. The Author(s).

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小类 | 1 区医学：内科

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第一作者机构： [1]Department of Oncology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China

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Safety and efficacy of apatinib in patients with advanced gastric or gastroesophageal junction adenocarcinoma after the failure of two or more lines of chemotherapy (AHEAD): a prospective, single-arm, multicenter, phase IV study

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