title: Subgroup analysis of East Asians in RAINBOW: A phase 3 trial of ramucirumab plus paclitaxel for advanced gastric cancer.
abstract: OBJECTIVE
  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.
authors: Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
authors: Kei
authors: K
authors: Muro
authors: Division of Oncology and Hematology, Department of Internal Medicine, College of Medicine, Korea University.
authors: Sang Cheul
authors: SC
authors: Oh
authors: National Cancer Center Hospital, Tokyo.
authors: Yasuhiro
authors: Y
authors: Shimada
authors: Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
authors: Keun-Wook
authors: KW
authors: Lee
authors: Graduate Institute of Clinical Medicine, National Cheng Kung University, Tainan.|Division of Hematology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, Tainan.
authors: Chia-Jui
authors: CJ
authors: Yen
authors: Faculty of Medicine, , National Yang-Ming University, Taipei.|Department of Oncology, Taipei Veterans General Hospital, Taipei.
authors: Yee
authors: Y
authors: Chao
authors: Department of Medical Oncology, Yonsei University College of Medicine, Gangnam Severance Hospital, Seoul.
authors: Jae Yong
authors: JY
authors: Cho
authors: Eli Lilly and Company, Taipei, Taiwan.
authors: Rebecca
authors: R
authors: Cheng
authors: Eli Lilly and Company, Sesto Fiorentino, Florence, Italy.
authors: Roberto
authors: R
authors: Carlesi
authors: Eli Lilly and Company, Bridgewater, New Jersey, USA.
authors: Kumari
authors: K
authors: Chandrawansa
authors: Eli Lilly and Company, Buenos Aires, Argentina.
authors: Mauro
authors: M
authors: Orlando
authors: Exploratory Oncology Research & Clinical Trial Center (EPOC), National Cancer Center, Kashiwa, Japan.
authors: Atsushi
authors: A
authors: Ohtsu
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D044466:Asian People; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000401:mortality; D004943:Esophagogastric Junction; D005202:Asia, Eastern; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate; D016896:Treatment Outcome; D000096662:Ramucirumab
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D017239:Paclitaxel; D000096662:Ramucirumab
keywords: Far East; gastrointestinal neoplasms; paclitaxel; ramucirumab; vascular endothelial growth factor receptor-2