title: A randomized, double-blind, placebo-controlled, Phase III study of pazopanib in patients with soft tissue sarcoma: results from the Japanese subgroup.
abstract: OBJECTIVE
  This analysis of the Japanese subpopulation of the PALETTE Phase III, randomized, placebo-controlled study investigated efficacy and safety of pazopanib in patients with metastatic soft tissue sarcoma after failure of standard chemotherapy.
  
  
  METHODS
  Patients were randomly assigned in a 2:1 ratio to receive either pazopanib 800 mg once daily or placebo, with no subsequent cross-over. Primary endpoint was progression-free survival. Secondary endpoints included overall survival and overall response rate. Efficacy analysis was by intent-to-treat. Safety was also investigated.
  
  
  RESULTS
  Forty-seven patients received either pazopanib (n = 31) or placebo (n = 16). Median progression-free survival was 7.0 weeks (95% confidence interval: 4.0-11.7) for placebo and 24.7 weeks (95% confidence interval: 8.6-28.1) for pazopanib (hazard ratio = 0.41 [95% confidence interval: 0.19-0.90]; P = 0.002). Median overall survival was 14.9 months (95% confidence interval: 6.8-not calculable) for placebo and 15.4 months (95% confidence interval: 7.9-28.8) for pazopanib (hazard ratio = 0.87 [95% confidence interval: 0.41-1.83]; P = 0.687). More patients receiving pazopanib experienced best response of stable disease versus placebo. Adverse events were similar to the global population; those leading to dose reduction were more common and mean daily dose was lower in the Japanese population versus the global population (45 vs. 32% and 624.4 vs. 700.4 mg, respectively).
  
  
  CONCLUSIONS
  The efficacy and safety of pazopanib observed in the Japanese subpopulation of PALETTE were similar to those in the global population. Pazopanib is a new treatment option for Japanese patients with metastatic non-adipocytic soft tissue sarcoma after chemotherapy.
  
  
  BACKGROUND
  NCT00753688; GSK study ID: VEG110727; http://www.gsk-clinicalstudyregister.com/study/VEG110727#ps.
authors: Head of Musculoskeletal Oncology and Rehabilitation Medicine, National Cancer Center Hospital, Tokyo akawai@ncc.go.jp.
authors: Akira
authors: A
authors: Kawai
authors: Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka.
authors: Nobuhito
authors: N
authors: Araki
authors: National Hospital Organization, Hokkaido Cancer Center, Hokkaidō
authors: Hiroaki
authors: H
authors: Hiraga
authors: Aichi Cancer Centre Hospital, Chikusa-ku Nagoya.
authors: Hideshi
authors: H
authors: Sugiura
authors: Mie University Hospital, Mie.
authors: Akihiko
authors: A
authors: Matsumine
authors: Okayama University Hospital, Okayama City.
authors: Toshifumi
authors: T
authors: Ozaki
authors: National Hospital Organization, Osaka National Hospital, Osaka.
authors: Takafumi
authors: T
authors: Ueda
authors: Chiba Cancer Center, Chiba.
authors: Takeshi
authors: T
authors: Ishii
authors: National Hospital Organization, Kyushu Cancer Center, Fukuoka City.
authors: Taito
authors: T
authors: Esaki
authors: Novartis, Tokyo, Japan.
authors: Michiko
authors: M
authors: Machida
authors: Novartis, Tokyo, Japan.
authors: Nobuaki
authors: N
authors: Fukasawa
mesh_terms: D000328:Adult; D000368:Aged; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007191:Indazoles; D007564:Japan; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011743:Pyrimidines / Q000627:therapeutic use*; D012509:Sarcoma / Q000188:drug therapy* / Q000401:mortality; D013449:Sulfonamides / Q000627:therapeutic use*; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors*
chemical_list: D020533:Angiogenesis Inhibitors; D007191:Indazoles; D011743:Pyrimidines; D013449:Sulfonamides; D042461:Vascular Endothelial Growth Factor A; C516667:pazopanib
keywords: pazopanib; randomized controlled trial; soft tissue sarcoma