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Effect of First-line S-1 Plus Oxaliplatin With or Without Ramucirumab Followed by Paclitaxel Plus Ramucirumab on Advanced Gastric Cancer in East Asia

Effect of First-line S-1 Plus Oxaliplatin With or Without Ramucirumab Followed by Paclitaxel Plus... Key PointsQuestionDoes the addition of ramucirumab to S-1 and oxaliplatin improve progression-free survival in patients with metastatic gastric or gastroesophageal junction adenocarcinoma in the first-line setting? FindingsIn this phase 2 randomized clinical trial of 189 East Asian patients with metastatic gastric or gastroesophageal junction adenocarcinoma, median progression-free survival was not prolonged in the ramucirumab plus S-1 and oxaliplatin arm compared with the placebo plus S-1 and oxaliplatin arm (6.34 vs 6.74 months). MeaningAddition of ramucirumab to first-line S-1 and oxaliplatin treatment did not improve progression-free survival, suggesting that the efficacy of ramucirumab in the second-line setting may not be applicable to the first-line setting when combined with fluoropyrimidine and platinum chemotherapy. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Network Open American Medical Association

Effect of First-line S-1 Plus Oxaliplatin With or Without Ramucirumab Followed by Paclitaxel Plus Ramucirumab on Advanced Gastric Cancer in East Asia

Key Points Question Does the addition of IMPORTANCE Ramucirumab, a human IgG 1 antibody against vascular endothelial growth factor ramucirumab to S-1 and oxaliplatin receptor 2, has been shown to improve progression-free survival and overall survival in patients with improve progression-free survival in advanced gastric cancer in the second-line setting. patients with metastatic gastric or gastroesophageal junction OBJECTIVE To compare progression-free survival for S-1 and oxaliplatin plus ramucirumab with that adenocarcinoma in the first-line setting? for S-1 and oxaliplatin plus placebo in patients with advanced gastric cancer. Findings In this phase 2 randomized clinical trial of 189 East Asian patients DESIGN, SETTING, AND PARTICIPANTS This phase 2, double-blind randomized clinical trial with metastatic gastric or (RAINSTORM [First-line S-1 Plus Oxaliplatin With or Without Ramucirumab Followed by Paclitaxel gastroesophageal junction Plus Ramucirumab in Patients With Advanced Gastric Cancer]) was conducted from October 12, 2015, adenocarcinoma, median progression- to April 11, 2018, at 36 sites in Japan, South Korea, and Taiwan. Participants were chemotherapy- free survival was not prolonged in the naive patients (n = 189) with metastatic gastric or gastroesophageal adenocarcinoma. Analyses of ramucirumab plus S-1 and oxaliplatin the full analysis set and safety population were conducted between November 27, 2017, and June arm compared with the placebo plus S-1 4, 2018. and oxaliplatin arm (6.34 vs 6.74 months). INTERVENTIONS Patients randomized to the ramucirumab plus S-1 and oxaliplatin arm received S-1, 80 to 120 mg/d twice daily, on days 1 to 14 and oxaliplatin, 100 mg/m , on day 1 with ramucirumab, Meaning Addition of ramucirumab to 8 mg/kg, on days 1 and 8 in part A (21-day cycle). Patients randomized to the placebo plus S-1 and first-line S-1 and oxaliplatin treatment oxaliplatin arm received the same S-1 and oxaliplatin dosage as well as placebo on...
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References (22)

Publisher
American Medical Association
Copyright
Copyright 2019 Yoshikawa T et al. JAMA Network Open.
eISSN
2574-3805
DOI
10.1001/jamanetworkopen.2019.8243
Publisher site
See Article on Publisher Site

Abstract

Key PointsQuestionDoes the addition of ramucirumab to S-1 and oxaliplatin improve progression-free survival in patients with metastatic gastric or gastroesophageal junction adenocarcinoma in the first-line setting? FindingsIn this phase 2 randomized clinical trial of 189 East Asian patients with metastatic gastric or gastroesophageal junction adenocarcinoma, median progression-free survival was not prolonged in the ramucirumab plus S-1 and oxaliplatin arm compared with the placebo plus S-1 and oxaliplatin arm (6.34 vs 6.74 months). MeaningAddition of ramucirumab to first-line S-1 and oxaliplatin treatment did not improve progression-free survival, suggesting that the efficacy of ramucirumab in the second-line setting may not be applicable to the first-line setting when combined with fluoropyrimidine and platinum chemotherapy.

Journal

JAMA Network OpenAmerican Medical Association

Published: Aug 2, 2019

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