Subgroup analysis of East Asians in RAINBOW: A phase 3 trial of ramucirumab plus paclitaxel for advanced gastric cancer
- Authors
- Muro, Kei; Oh, Sang Cheul; Shimada, Yasuhiro; Lee, Keun-Wook; Yen, Chia-Jui; Chao, Yee; Cho, Jae Yong; Cheng, Rebecca; Carlesi, Roberto; Chandrawansa, Kumari; Orlando, Mauro; Ohtsu, Atsushi
- Issue Date
- 3월-2016
- Publisher
- WILEY
- Keywords
- Far East; gastrointestinal neoplasms; paclitaxel; ramucirumab; vascular endothelial growth factor receptor-2
- Citation
- JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, v.31, no.3, pp.581 - 589
- Indexed
- SCIE
SCOPUS
- Journal Title
- JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY
- Volume
- 31
- Number
- 3
- Start Page
- 581
- End Page
- 589
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/89435
- DOI
- 10.1111/jgh.13153
- ISSN
- 0815-9319
- Abstract
- Background and AimEast Asia has higher gastric cancer incidence and mortality rates than other regions. We present a subgroup analysis of East Asians in the positive study RAINBOW. MethodsPatients with advanced gastric or gastroesophageal junction adenocarcinoma previously treated with platinum and fluoropyrimidine received ramucirumab 8mg/kg or placebo on days 1 and 15 plus paclitaxel 80mg/m(2) on days 1, 8, and 15 of a 28-day cycle. ResultsOf 665 intention-to-treat patients, 223 were East Asian. Median overall survival was 12.1months for ramucirumab plus paclitaxel and 10.5months for placebo plus paclitaxel (hazard ratio: 0.986, 95% confidence interval: 0.727-1.337, P=0.929). Median progression-free survival was 5.5months for ramucirumab plus paclitaxel and 2.8months for placebo plus paclitaxel (hazard ratio: 0.628, 95% confidence interval: 0.473-0.834, P=0.001). Objective response rates were 34% for ramucirumab plus paclitaxel and 20% for placebo plus paclitaxel. Grade 3 neutropenia (60% vs 28%) and leukopenia (34% vs 13%) were higher for ramucirumab plus paclitaxel. The rate of febrile neutropenia was low (4% vs 4%). Special interest adverse events included any grade bleeding/hemorrhage (55% vs 25%), proteinuria (27% vs 7%), and hypertension (22% vs 2%). ConclusionsRamucirumab plus paclitaxel significantly improves progression-free survival and response rate, with prolonged median overall survival and an acceptable safety profile in East Asians with advanced gastric cancer.
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Collections - Graduate School > Department of Biomedical Sciences > 1. Journal Articles
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