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Subgroup analysis of East Asians in RAINBOW: A phase 3 trial of ramucirumab plus paclitaxel for advanced gastric cancer
Author(s) -
Muro Kei,
Oh Sang Cheul,
Shimada Yasuhiro,
Lee KeunWook,
Yen ChiaJui,
Chao Yee,
Cho Jae Yong,
Cheng Rebecca,
Carlesi Roberto,
Chandrawansa Kumari,
Orlando Mauro,
Ohtsu Atsushi
Publication year - 2016
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1111/jgh.13153
Subject(s) - ramucirumab , medicine , paclitaxel , hazard ratio , neutropenia , gastroenterology , leukopenia , placebo , confidence interval , cancer , oncology , surgery , chemotherapy , pathology , alternative medicine
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.