Abstract | BACKGROUND: 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: In this open-label, single-arm, phase 2 trial, in each 21-day cycle, eligible patients received 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 until the trail was discontinued disease progression, development of intolerable toxicity, or withdrawal of consent. The primary endpoints were progression-free survival. The secondary endpoints were objective response rates, disease control rates, and safety, and overall survival. This study was registered at ClinicalTrials.gov, NCT04338438. RESULTS: 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. At the data cutoff, the 6-month progression-free survival was 31.5%, the median progression-free survival and overall survival were 4.2 (95% CI: 3.50-4.90) months and 8.2 (95% CI: 4.69-11.71) 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, especially for the elder patients with poor performance status. TRIAL REGISTRATION: NCT04338438.
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Authors | Chao Jing, Zhigang Bai, Jun Zhang, Hongpeng Jiang, Xiaobao Yang, Shu Yan, Jie Yin, Jun Cai, Zhongtao Zhang, Wei Deng |
Journal | Journal of gastrointestinal oncology
(J Gastrointest Oncol)
Vol. 12
Issue 5
Pg. 2035-2044
(Oct 2021)
ISSN: 2078-6891 [Print] China |
PMID | 34790371
(Publication Type: Journal Article)
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Copyright | 2021 Journal of Gastrointestinal Oncology. All rights reserved. |