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

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

研究成果: Article同行評審

28 引文 斯高帕斯(Scopus)

摘要

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 8mg/kg or placebo on days 1 and 15 plus paclitaxel 80mg/m2 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 12.1months 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%). 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.

原文English
頁(從 - 到)581-589
頁數9
期刊Journal of Gastroenterology and Hepatology (Australia)
31
發行號3
DOIs
出版狀態Published - 2016 3月 1

All Science Journal Classification (ASJC) codes

  • 肝病
  • 消化內科

指紋

深入研究「Subgroup analysis of East Asians in RAINBOW: A phase 3 trial of ramucirumab plus paclitaxel for advanced gastric cancer」主題。共同形成了獨特的指紋。

引用此