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Subgroup analysis of East Asians in RAINBOW: A phase 3 trial of ramucirumab plus paclitaxel for advanced gastric cancer

Authors
 Kei Muro  ;  Sang Cheul Oh  ;  Yasuhiro Shimada  ;  Keun‐Wook Lee  ;  Chia‐Jui Yen  ;  Yee Chao  ;  Jae Yong Cho  ;  Rebecca Cheng  ;  Roberto Carlesi  ;  Kumari Chandrawansa  ;  Mauro Orlando  ;  Atsushi Ohtsu 
Citation
 Journal of Gastroenterology and Hepatology, Vol.31(3) : 581-589, 2016 
Journal Title
 Journal of Gastroenterology and Hepatology 
ISSN
 0815-9319 
Issue Date
2016
MeSH
Adenocarcinoma/drug therapy* ; Adenocarcinoma/mortality ; Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Asian Continental Ancestry Group ; Esophageal Neoplasms/drug therapy* ; Esophageal Neoplasms/mortality ; Esophagogastric Junction* ; Far East ; Female ; Humans ; Male ; Middle Aged ; Paclitaxel/administration & dosage ; Stomach Neoplasms/drug therapy* ; Stomach Neoplasms/mortality ; Survival Rate ; Treatment Outcome
Keywords
Far East ; gastrointestinal neoplasms ; paclitaxel ; ramucirumab ; vascular endothelial growth factor receptor-2
Abstract
BACKGROUND AND AIM: East 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. METHODS: Patients with advanced gastric or gastroesophageal junction adenocarcinoma previously treated with platinum and fluoropyrimidine received ramucirumab 8 mg/kg or placebo on days 1 and 15 plus paclitaxel 80 mg/m(2) on days 1, 8, and 15 of a 28-day cycle. RESULTS: Of 665 intention-to-treat patients, 223 were East Asian. Median overall survival was 12.1 months for ramucirumab plus paclitaxel and 10.5 months for placebo plus paclitaxel (hazard ratio: 0.986, 95% confidence interval: 0.727-1.337, P = 0.929). Median progression-free survival was 5.5 months for ramucirumab plus paclitaxel and 2.8 months 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%). CONCLUSIONS: Ramucirumab 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.
DOI
10.1111/jgh.13153
Appears in Collections:
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실)
Yonsei Authors
조재용(Cho, Jae Yong) ORCID logo https://orcid.org/0000-0002-0926-1819
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URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/165779
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