title: Efficacy, safety, and survival factors for sorafenib treatment in Japanese patients with advanced hepatocellular carcinoma.
abstract: BACKGROUND
  Sorafenib, an oral multikinase inhibitor, was approved for the treatment of advanced hepatocellular carcinoma (HCC), but has not been adequately evaluated for safety and effectiveness in Japanese patients with advanced HCC.
  
  
  OBJECTIVE
  The purpose of this study was to prospectively assess the efficacy, safety, and risk factors for survival in patients with advanced HCC treated with sorafenib.
  
  
  METHODS
  Between May 2009 and December 2010, 96 Japanese patients with advanced HCC (76 male, 20 female, mean age: 70.4 years) were treated with sorafenib. Eighty-eight patients had Child-Pugh class A, and 8 patients had Child-Pugh class B liver cirrhosis. Barcelona Clinic Liver Cancer stage B and C were found in 64 and 32 patients, respectively.
  
  
  RESULTS
  Twelve patients demonstrated partial response to sorafenib therapy, 43 patients had stable disease, and 33 patients had progressive disease at the first radiologic assessment. The most frequent adverse events leading to discontinuation of sorafenib treatment were liver dysfunction (n = 8), hand-foot skin reaction (n = 7), and diarrhea (n = 4). The median survival time and time to progression were 11.6 and 3.2 months, respectively. By multivariate analysis, des-γ-carboxy prothrombin serum levels and duration of treatment were identified as independent risk factors for survival.
  
  
  CONCLUSIONS
  This study showed that sorafenib was safe and useful in Japanese patients with advanced HCC. In addition, this study demonstrated that sorafenib should be administered as a long-term treatment for advanced HCC regardless of therapeutic effect and dosage.
authors.affiliation: Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan. nakano_masahito@kurume-u.ac.jp
authors.forename: Masahito
authors.initials: M
authors.lastname: Nakano
authors.forename: Masatoshi
authors.initials: M
authors.lastname: Tanaka
authors.forename: Ryoko
authors.initials: R
authors.lastname: Kuromatsu
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Nagamatsu
authors.forename: Kenji
authors.initials: K
authors.lastname: Sakata
authors.forename: Satoru
authors.initials: S
authors.lastname: Matsugaki
authors.forename: Masahiko
authors.initials: M
authors.lastname: Kajiwara
authors.forename: Kunitaka
authors.initials: K
authors.lastname: Fukuizumi
authors.forename: Nobuyoshi
authors.initials: N
authors.lastname: Tajiri
authors.forename: Norito
authors.initials: N
authors.lastname: Matsukuma
authors.forename: Terufumi
authors.initials: T
authors.lastname: Sakai
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Ono
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Yano
authors.forename: Hironori
authors.initials: H
authors.lastname: Koga
authors.forename: Junichi
authors.initials: J
authors.lastname: Kurogi
authors.forename: Akio
authors.initials: A
authors.lastname: Takata
authors.forename: Shuji
authors.initials: S
authors.lastname: Sumie
authors.forename: Manabu
authors.initials: M
authors.lastname: Satani
authors.forename: Shingo
authors.initials: S
authors.lastname: Yamada
authors.forename: Takashi
authors.initials: T
authors.lastname: Niizeki
authors.forename: Hajime
authors.initials: H
authors.lastname: Aino
authors.forename: Hideki
authors.initials: H
authors.lastname: Iwamoto
authors.forename: Takuji
authors.initials: T
authors.lastname: Torimura
authors.forename: Michio
authors.initials: M
authors.lastname: Sata
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People; D001557:Benzenesulfonates / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D011379:Prognosis; D011446:Prospective Studies; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*; D011725:Pyridines / Q000627:therapeutic use*; D012307:Risk Factors; D012449:Safety; D000077157:Sorafenib; D015996:Survival Rate; D048490:raf Kinases / Q000037:antagonists & inhibitors
chemical_list: D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D047428:Protein Kinase Inhibitors; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib; D048490:raf Kinases