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Apatinib plus S-1 for previously treated, advanced gastric or gastro-oesophageal junction adenocarcinoma: a phase 2, single-arm, prospective study
  • +8
  • Chao Jing,
  • Zhigang Bai,
  • Jun Zhang,
  • Hongpeng Jiang,
  • Kai Pang,
  • Xiaobao Yang,
  • Shu Yan,
  • Jie Yin,
  • Jun Cai,
  • Zhongtao Zhang,
  • Wei Deng
Chao Jing
Capital Medical University Affiliated Beijing Friendship Hospital
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Zhigang Bai
Capital Medical University Affiliated Beijing Friendship Hospital
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Jun Zhang
Capital Medical University Affiliated Beijing Friendship Hospital
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Hongpeng Jiang
Capital Medical University Affiliated Beijing Friendship Hospital
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Kai Pang
Capital Medical University Affiliated Beijing Friendship Hospital
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Xiaobao Yang
Capital Medical University Affiliated Beijing Friendship Hospital
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Shu Yan
Capital Medical University Affiliated Beijing Friendship Hospital
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Jie Yin
Capital Medical University Affiliated Beijing Friendship Hospital
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Jun Cai
Capital Medical University Affiliated Beijing Friendship Hospital
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Zhongtao Zhang
Capital Medical University Affiliated Beijing Friendship Hospital
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Wei Deng
Capital Medical University Affiliated Beijing Friendship Hospital
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Abstract

Aim: The current management of advanced gastric or gastro-oesophageal junction adenocarcinoma remains unsatisfactory. We investigated the efficacy and safety of the combination therapy of apatinib and S-1, considering the potential advantage of home-based treatment without hospital admission, in patients with platinum-refractory gastric or gastro-oesophageal junction adenocarcinoma. Methods:Between April 2015 and May 2019, we included 37 patients with advanced gastric or gastro-oesophageal junction adenocarcinoma refractory to first-line platinum-containing therapy, who were treated with apatinib at an initial dose of 500 mg once daily continuously and S-1 at a dose of 40-60 mg twice daily on days 1-14 of a 21-day cycle. The primary endpoints were progression-free survival (PFS) and overall survival (OS). The secondary endpoints were objective response rates, disease control rates, and safety. Results:At the data cutoff, the median PFS and OS were 4.2 months and 8.2 months, respectively. Of 37 eligible patients, 8 (21.6%) patients reached objective responses, 31 (83.8%) patients reached disease control. Grade 3 or 4 adverse events occurred in 8 (21.6%) patients, including hand-foot syndrome, hypertension, and diarrhea, etc. Conclusions: The combination of Apatinib and S-1 showed promising efficacy and manageable toxicity as a home-based, second-line therapy in patients with advanced gastric or gastro-oesophageal junction adenocarcinoma refractory to platinum-containing therapy.

Peer review status:UNDER REVIEW

19 Jul 2020Submitted to British Journal of Clinical Pharmacology
24 Jul 2020Assigned to Editor
24 Jul 2020Submission Checks Completed
21 Aug 2020Reviewer(s) Assigned