title: Randomized phase III trial of regorafenib in metastatic colorectal cancer: analysis of the CORRECT Japanese and non-Japanese subpopulations.
abstract: BACKGROUND
  In the international, phase III, randomized, double-blind CORRECT trial, regorafenib significantly prolonged overall survival (OS) versus placebo in patients with metastatic colorectal cancer (mCRC) that had progressed on all standard therapies. This post hoc analysis evaluated the efficacy and safety of regorafenib in Japanese and non-Japanese subpopulations in the CORRECT trial.
  
  
  METHODS
  Patients were randomized 2 : 1 to regorafenib 160 mg once daily or placebo for weeks 1-3 of each 4-week cycle. The primary endpoint was OS. Outcomes were assessed using descriptive statistics.
  
  
  RESULTS
  One hundred Japanese and 660 non-Japanese patients were randomized to regorafenib (n = 67 and n = 438) or placebo (n = 33 and n = 222). Regorafenib had a consistent OS benefit in the Japanese and non-Japanese subpopulations, with hazard ratios of 0.81 (95 % confidence interval [CI] 0.43-1.51) and 0.77 (95 % CI 0.62-0.94), respectively. Regorafenib-associated hand-foot skin reaction, hypertension, proteinuria, thrombocytopenia, and lipase elevations occurred more frequently in the Japanese subpopulation than in the non-Japanese subpopulation, but were generally manageable.
  
  
  CONCLUSIONS
  Regorafenib appears to have comparable efficacy in Japanese and non-Japanese subpopulations, with a manageable adverse-event profile, suggesting that this agent could potentially become a standard of care in patients with mCRC.
authors.affiliation: Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, 277-8577, Chiba, Japan, tyoshino@east.ncc.go.jp.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Yoshino
authors.forename: Yoshito
authors.initials: Y
authors.lastname: Komatsu
authors.forename: Yasuhide
authors.initials: Y
authors.lastname: Yamada
authors.forename: Kentaro
authors.initials: K
authors.lastname: Yamazaki
authors.forename: Akihito
authors.initials: A
authors.lastname: Tsuji
authors.forename: Takashi
authors.initials: T
authors.lastname: Ura
authors.forename: Axel
authors.initials: A
authors.lastname: Grothey
authors.forename: Eric
authors.initials: E
authors.lastname: Van Cutsem
authors.forename: Andrea
authors.initials: A
authors.lastname: Wagner
authors.forename: Frank
authors.initials: F
authors.lastname: Cihon
authors.forename: Yoko
authors.initials: Y
authors.lastname: Hamada
authors.forename: Atsushi
authors.initials: A
authors.lastname: Ohtsu
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D019540:Area Under Curve; D044466:Asian People; D015992:Body Mass Index; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D003710:Demography; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010671:Phenylurea Compounds / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D010919:Placebos; D011725:Pyridines / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D010919:Placebos; D011725:Pyridines; C559147:regorafenib