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. 2021 Journal of Gastrointestinal Oncology. All rights reserved.
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. 2021 Journal of Gastrointestinal Oncology. All rights reserved.
Authors: C J van Groeningen; G J Peters; J H Schornagel; H Gall; P Noordhuis; M J de Vries; S L Turner; M S Swart; H M Pinedo; A R Hanauske; G Giaccone Journal: J Clin Oncol Date: 2000-07 Impact factor: 44.544
Authors: Jaffer A Ajani; Thomas A D'Amico; Khaldoun Almhanna; David J Bentrem; Joseph Chao; Prajnan Das; Crystal S Denlinger; Paul Fanta; Farhood Farjah; Charles S Fuchs; Hans Gerdes; Michael Gibson; Robert E Glasgow; James A Hayman; Steven Hochwald; Wayne L Hofstetter; David H Ilson; Dawn Jaroszewski; Kimberly L Johung; Rajesh N Keswani; Lawrence R Kleinberg; W Michael Korn; Stephen Leong; Catherine Linn; A Craig Lockhart; Quan P Ly; Mary F Mulcahy; Mark B Orringer; Kyle A Perry; George A Poultsides; Walter J Scott; Vivian E Strong; Mary Kay Washington; Benny Weksler; Christopher G Willett; Cameron D Wright; Debra Zelman; Nicole McMillian; Hema Sundar Journal: J Natl Compr Canc Netw Date: 2016-10 Impact factor: 11.908
Authors: Giandomenico Roviello; Andrea Ravelli; Karol Polom; Roberto Petrioli; Luigi Marano; Daniele Marrelli; Franco Roviello; Daniele Generali Journal: Cancer Lett Date: 2016-01-18 Impact factor: 8.679