title: Bevacizumab plus capecitabine and cisplatin in Chinese patients with inoperable locally advanced or metastatic gastric or gastroesophageal junction cancer: randomized, double-blind, phase III study (AVATAR study).
abstract: BACKGROUND
  In the AVAGAST study, fluoropyrimidine and cisplatin plus bevacizumab did not significantly improve overall survival (OS) versus fluoropyrimidine and cisplatin plus placebo in patients with advanced gastric cancer. Geographic differences in efficacy were observed in AVAGAST, but the study only included 12 Chinese patients. AVATAR, a study similar in design to AVAGAST, was a randomized, double-blind, phase III study conducted in Chinese patients with advanced gastric cancer.
  
  
  METHODS
  Patients more than 18 years of age with gastric adenocarcinoma were randomized 1:1 to capecitabine-cisplatin plus either bevacizumab or placebo. The primary endpoint was OS; secondary endpoints included progression-free survival (PFS) and safety.
  
  
  RESULTS
  In total, 202 patients were included (placebo n = 102; bevacizumab n = 100). Baseline characteristics were well balanced. The primary analysis result did not show a difference in OS for the bevacizumab arm compared to the placebo arm [hazard ratio, 1.11 (95% CI, 0.79-1.56); P = 0.5567]. Median PFS was also similar in both arms. Bevacizumab plus capecitabine-cisplatin was well tolerated. Grade 3-5 adverse events (AEs) occurred in 60% of bevacizumab-treated and 68% of placebo-treated patients, respectively. Grade 3-5 AEs of special interest with bevacizumab occurred in 8% of bevacizumab-treated patients and 15% of placebo-treated patients, mainly grade 3-5 hemorrhage (bevacizumab 4%, placebo 12%).
  
  
  CONCLUSIONS
  Addition of bevacizumab to capecitabine-cisplatin in Chinese patients with advanced gastric cancer did not improve outcomes in AVATAR. There was no difference in OS between the two arms and PFS was similar in both arms. Safety findings were as previously experienced with bevacizumab, including AVAGAST; no new safety signals were reported.
authors.affiliation: Peking University Cancer Hospital and Institute, No 52 Fucheng Road, Haidian District, Beijing, China, Lin100@medmail.com.cn.
authors.forename: Lin
authors.initials: L
authors.lastname: Shen
authors.forename: Jin
authors.initials: J
authors.lastname: Li
authors.forename: Jianming
authors.initials: J
authors.lastname: Xu
authors.forename: Hongming
authors.initials: H
authors.lastname: Pan
authors.forename: Guanghai
authors.initials: G
authors.lastname: Dai
authors.forename: Shukui
authors.initials: S
authors.lastname: Qin
authors.forename: Liwei
authors.initials: L
authors.lastname: Wang
authors.forename: Jinwan
authors.initials: J
authors.lastname: Wang
authors.forename: Zhenzhou
authors.initials: Z
authors.lastname: Yang
authors.forename: Yongqian
authors.initials: Y
authors.lastname: Shu
authors.forename: Ruihua
authors.initials: R
authors.lastname: Xu
authors.forename: Lei
authors.initials: L
authors.lastname: Chen
authors.forename: Yunpeng
authors.initials: Y
authors.lastname: Liu
authors.forename: Shiying
authors.initials: S
authors.lastname: Yu
authors.forename: Lilian
authors.initials: L
authors.lastname: Bu
authors.forename: Yongzhe
authors.initials: Y
authors.lastname: Piao
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000401:mortality / Q000473:pathology; D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use*; D044466:Asian People; D000068258:Bevacizumab; D000069287:Capecitabine; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004311:Double-Blind Method; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D004943:Esophagogastric Junction / Q000473:pathology*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D008875:Middle Aged; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D003841:Deoxycytidine; D000068258:Bevacizumab; D000069287:Capecitabine; D002945:Cisplatin; D005472:Fluorouracil