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Effectiveness and Safety of Apatinib in Patients with Advanced or Metastatic Adenocarcinoma of Stomach or Gastroesophageal Junction: A Prospective Observation Study

Authors Shen B, Jiang H, Wang L, Qian J, Shu Y, Chen P, Mao G, Liu B, Zhang X, Liu C, Wu J, Li X, Cai W, Shen W, Wang Q, He J, Hua D, Zhang Z, Zhang Y, Feng J

Received 24 September 2019

Accepted for publication 10 April 2020

Published 20 May 2020 Volume 2020:13 Pages 4457—4464


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 2

Editor who approved publication: Dr Tohru Yamada

Bo Shen,1,* Hua Jiang,2,* Lin Wang,3,* Jun Qian,4,* Yongqian Shu,5 Ping Chen,6 Guoxin Mao,7 Baorui Liu,8 Xizhi Zhang,9 Chaoying Liu,10 Jun Wu,11 Xiaoqin Li,12 Wei Cai,13 Wenxiang Shen,14 Qiong Wang,15 Jingdong He,16 Dong Hua,17 Ziwen Zhang,18 Youcheng Zhang,19 Jifeng Feng1

1Department 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; 2Department of Oncology, Changzhou No. 2 People’s Hospital, Changzhou, People’s Republic of China; 3Department of Oncology, Bayi Hospital of People’s Liberation Army, Nanjing, People’s Republic of China; 4Department of Oncology, Suzhou Municipal Hospital, Suzhou, People’s Republic of China; 5Department of Oncology, Jiangsu Province Hospital, Nanjing, People’s Republic of China; 6Department of Oncology, Yancheng City No. 1 People’s Hospital, Yancheng, People’s Republic of China; 7Department of Oncology, Affiliated Hospital of Nantong University, Nantong, People’s Republic of China; 8Department of Oncology, Nanjing Drum Tower Hospital, Nanjing, People’s Republic of China; 9Department of Oncology, Northern Jiangsu People’s Hospital, Yangzhou, People’s Republic of China; 10Department of Oncology, Wuxi People’s Hospital, Wuxi, People’s Republic of China; 11Department of Oncology, The First People’s Hospital of Changzhou, Changzhou, People’s Republic of China; 12Department of Oncology, Affiliated Hospital of Jiangsu University, Zhenjiang, People’s Republic of China; 13Department of Oncology, The First People’s Hospital of Wujiang, Wujiang, People’s Republic of China; 14Department of Oncology, The First People’s Hospital of Kunshan, Kunshan, People’s Republic of China; 15Department of Oncology, Jiangyin People’s Hospital, Jiangyin, People’s Republic of China; 16Department of Oncology, Huai’an First People’s Hospital, Huai’an, People’s Republic of China; 17Department of Oncology, Affiliated Hospital of Jiangnan University and Fourth People’s Hospital of Wuxi, Wuxi, People’s Republic of China; 18Department of Oncology, Changshu No. 2 People’s Hospital, Changshu, People’s Republic of China; 19Department of Oncology, Jiangning People’s Hospital, Nanjing, People’s Republic of China

*These authors contributed equally to this work

Correspondence: Jifeng Feng Nanjing 210000, People’s Republic of China
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Fax +8625-83283597

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).

Keywords: apatinib, gastric cancer, non-intervention, VEGFR2 inhibitor

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