title: Efficacy of bevacizumab with cisplatin and gemcitabine in Asian patients with advanced or recurrent non-squamous non-small cell lung cancer who have not received prior chemotherapy: a substudy of the Avastin in Lung trial.
abstract: OBJECTIVE
  The phase III AVAiL study evaluated the efficacy and safety of the anti-vascular epidermal growth factor agent bevacizumab combined with platinum-based chemotherapy as first-line treatment in patients with advanced non-small-cell lung cancer (NSCLC). We report the results of a preplanned analysis of Asian patients enrolled in AVAiL.
  
  
  METHODS
  Patients with recurrent or advanced non-squamous NSCLC were randomized to receive bevacizumab 7.5 mg/kg, bevacizumab 15 mg/kg or placebo, plus cisplatin 80 mg/m(2) and gemcitabine 1250 mg/m(2) for up to six cycles, followed by bevacizumab or placebo until disease progression. An exploratory analysis was undertaken to assess efficacy and safety in an Asian subgroup.
  
  
  RESULTS
  Of the 1043 patients enrolled, 105 were Asian and were included in the subgroup analysis. Progression-free survival was 8.5 months (95% CI 7.3-10.8) in the bevacizumab 15-mg/kg group, 8.2 (95% CI 6.6-11.7) in the 7.5-mg/kg group and 6.1 (95% CI 5.1-8.0) in the placebo group. Median overall survival in the 7.5-mg/kg bevacizumab group was prolonged compared with placebo group (HR 0.46; 95% CI 0.22-0.97). Nausea was the most common adverse event, occurring at similar rates (ranging from 69-76%) in all study groups. Hypertension was the most common adverse event of special interest, seen in 29, 55 and 16% of patients in the 7.5-mg/kg and 15-mg/kg bevacizumab and placebo groups, respectively.
  
  
  CONCLUSIONS
  Study results strongly suggest that bevacizumab at a dose of 7.5 mg/kg improves the duration of overall survival when combined with cisplatin-gemcitabine in Asian patients. Bevacizumab was well tolerated in this patient group.
authors.affiliation: State Key Laboratory of Southern China, Chinese University of Hong Kong, Sir YK Pau Cancer Center, Prince of Wales Hospital Central, Hong Kong, China. tony@clo.cuhk.edu.hk
authors.forename: Tony S K
authors.initials: TS
authors.lastname: Mok
authors.forename: Te-Chun
authors.initials: TC
authors.lastname: Hsia
authors.forename: Chun-Ming
authors.initials: CM
authors.lastname: Tsai
authors.forename: Kenneth
authors.initials: K
authors.lastname: Tsang
authors.forename: Gee-Chen
authors.initials: GC
authors.lastname: Chang
authors.forename: John Wen-Cheng
authors.initials: JW
authors.lastname: Chang
authors.forename: Thitiya
authors.initials: T
authors.lastname: Sirisinha
authors.forename: Sirisinha
authors.initials: S
authors.lastname: Thitiya
authors.forename: Virote
authors.initials: V
authors.lastname: Sriuranpong
authors.forename: Sumitra
authors.initials: S
authors.lastname: Thongprasert
authors.forename: Daniel T T
authors.initials: DT
authors.lastname: Chua
authors.forename: Nicola
authors.initials: N
authors.lastname: Moore
authors.forename: Christian
authors.initials: C
authors.lastname: Manegold
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001208:Asia; D044466:Asian People; D000068258:Bevacizumab; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D000093542:Gemcitabine
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003841:Deoxycytidine; D000068258:Bevacizumab; D002945:Cisplatin; D000093542:Gemcitabine