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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: The Phase 2 RAINSTORM Randomized Clinical Trial

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dc.contributor.author정현철-
dc.date.accessioned2019-12-18T00:47:01Z-
dc.date.available2019-12-18T00:47:01Z-
dc.date.issued2019-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/173217-
dc.description.abstractImportance: Ramucirumab, a human IgG 1 antibody against vascular endothelial growth factor receptor 2, has been shown to improve progression-free survival and overall survival in patients with advanced gastric cancer in the second-line setting. Objective: To compare progression-free survival for S-1 and oxaliplatin plus ramucirumab with that for S-1 and oxaliplatin plus placebo in patients with advanced gastric cancer. Design, Setting, and Participants: This phase 2, double-blind randomized clinical trial (RAINSTORM [First-line S-1 Plus Oxaliplatin With or Without Ramucirumab Followed by Paclitaxel Plus Ramucirumab in Patients With Advanced Gastric Cancer]) was conducted from October 12, 2015, to April 11, 2018, at 36 sites in Japan, South Korea, and Taiwan. Participants were chemotherapy-naive patients (n = 189) with metastatic gastric or gastroesophageal adenocarcinoma. Analyses of the full analysis set and safety population were conducted between November 27, 2017, and June 4, 2018. 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/m2, on day 1 with ramucirumab, 8 mg/kg, on days 1 and 8 in part A (21-day cycle). Patients randomized to the placebo plus S-1 and oxaliplatin arm received the same S-1 and oxaliplatin dosage as well as placebo on days 1 and 8 in part A. Eligible patients received second-line paclitaxel, 80 mg/m2, on days 1, 8, and 15 and ramucirumab, 8 mg/kg, on days 1 and 15 in part B (28-day cycle). Main Outcomes and Measures: The primary end point was progression-free survival, analyzed using the stratified log-rank test; the hazard ratio (HR) was estimated using the stratified Cox proportional hazards regression model. Secondary end points included overall survival and adverse events. Results: In total, 189 patients were randomized and received treatment: 96 to the ramucirumab plus S-1 and oxaliplatin arm and 93 to the placebo plus S-1 and oxaliplatin arm. Among the 189 patients, 121 (64.0%) were male, and the median (range) age was 62.0 (26-84) years. 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 [80% CI, 5.65-6.93] vs 6.74 [80% CI, 5.75-7.13] months; HR, 1.07; 80% CI, 0.86-1.33; P = .70). Median overall survival was 14.65 (80% CI, 12.39-15.67) months in the ramucirumab plus S-1 and oxaliplatin arm and 14.26 (80% CI, 13.83-17.31) months in the placebo plus S-1 and oxaliplatin arm (HR, 1.11; 80% CI, 0.89-1.40; P = .55). The most commonly reported grade 3 or higher treatment-emergent adverse events in the ramucirumab plus S-1 and oxaliplatin arm in part A were decreased neutrophil count (14 patients [14.6%]), hypertension (10 patients [10.4%]), and anemia (10 patients [10.4%]). Conclusions and Relevance: In this randomized clinical trial, the addition of ramucirumab to first-line S-1 and oxaliplatin treatment did not prolong progression-free survival or overall survival compared with S-1 and oxaliplatin alone among East Asian patients with advanced gastric cancer; no new safety signals for ramucirumab were identified. Trial Registration: ClinicalTrials.gov identifier: NCT02539225.-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherAmerican Medical Association-
dc.relation.isPartOfJAMA Network Open-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.titleEffect of First-line S-1 Plus Oxaliplatin With or Without Ramucirumab Followed by Paclitaxel Plus Ramucirumab on Advanced Gastric Cancer in East Asia: The Phase 2 RAINSTORM Randomized Clinical Trial-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorTakaki Yoshikawa-
dc.contributor.googleauthorKei Muro-
dc.contributor.googleauthorKohei Shitara-
dc.contributor.googleauthorDo-Youn Oh-
dc.contributor.googleauthorYoon-Koo Kang-
dc.contributor.googleauthorHyun Cheol Chung-
dc.contributor.googleauthorToshihiro Kudo-
dc.contributor.googleauthorKeisho Chin-
dc.contributor.googleauthorShigenori Kadowaki-
dc.contributor.googleauthorYasuo Hamamoto-
dc.contributor.googleauthorShuichi Hironaka-
dc.contributor.googleauthorKazuhiro Yoshida-
dc.contributor.googleauthorChia-Jui Yen-
dc.contributor.googleauthorYasushi Omuro-
dc.contributor.googleauthorLi-Yuan Bai-
dc.contributor.googleauthorKaijiro Maeda-
dc.contributor.googleauthorAkichika Ozeki-
dc.contributor.googleauthorReigetsu Yoshikawa-
dc.contributor.googleauthorYuko Kitagawa-
dc.identifier.doi10.1001/jamanetworkopen.2019.8243-
dc.contributor.localIdA03773-
dc.relation.journalcodeJ03719-
dc.identifier.eissn2574-3805-
dc.identifier.pmid31373648-
dc.contributor.alternativeNameChung, Hyun Cheol-
dc.contributor.affiliatedAuthor정현철-
dc.citation.volume2-
dc.citation.number8-
dc.citation.startPagee198243-
dc.identifier.bibliographicCitationJAMA Network Open, Vol.2(8) : e198243, 2019-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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