title: Field practice study of half-dose sorafenib treatment on safety and efficacy for hepatocellular carcinoma: A propensity score analysis.
abstract: OBJECTIVE
  Patients with hepatocellular carcinoma (HCC) who receive an initial full dose of sorafenib (800 mg/day) often require a decreased dose (400 mg/day) or discontinuation of therapy because of severe adverse events. We conducted a retrospective analysis of patients with HCC to compare the safety and efficacy of full- to half-dose sorafenib.
  
  
  METHODS
  We reviewed the medical records of 218 consecutive patients with intermediate or advanced stage HCC who received half (n = 73) or full-dose sorafenib (n = 145) between 2009 and 2012 at four institutions. A propensity score-matching analysis was used to adjust for potential bias.
  
  
  RESULTS
  Multivariate logistic regression analysis showed that increased age was an independent factor for the selection of initial half-dose sorafenib (odds ratio, 1.10; 95% confidence interval, 1.05-1.15; P < 0.001). Fifty-eight patients each in the half-dose and full-dose groups were selected for propensity score matching. The incidence of grade 3-4 severe adverse effects was lower in the half-dose group (47.4% vs 66.7%, P = 0.037). In contrast, the median progression-free survival (PFS) and overall survival (OS) rates were not significantly different (half-dose group, 3.8 and 10.2 months; full-dose group, 2.5 and 8.8 months; P = 0.143 and 0.911, respectively).
  
  
  CONCLUSIONS
  Propensity score-matched analyses indicate that initial half-dose sorafenib treatment led to fewer severe adverse effects and a comparable survival benefit compared with a full dose in select patients with HCC, particularly for those of advanced age.
authors.affiliation: Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan; Department of Hepatobiliary and Pancreatic Medical Oncology, Kanagawa Cancer Center, Yokohama, Japan.
authors.forename: Manabu
authors.initials: M
authors.lastname: Morimoto
authors.forename: Kazushi
authors.initials: K
authors.lastname: Numata
authors.forename: Masaaki
authors.initials: M
authors.lastname: Kondo
authors.forename: Satoshi
authors.initials: S
authors.lastname: Kobayashi
authors.forename: Shinichi
authors.initials: S
authors.lastname: Ohkawa
authors.forename: Hisashi
authors.initials: H
authors.lastname: Hidaka
authors.forename: Takahide
authors.initials: T
authors.lastname: Nakazawa
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Okuwaki
authors.forename: Chiaki
authors.initials: C
authors.lastname: Okuse
authors.forename: Kotaro
authors.initials: K
authors.lastname: Matsunaga
authors.forename: Michihiro
authors.initials: M
authors.lastname: Suzuki
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Masataka
authors.initials: M
authors.lastname: Taguri
authors.forename: Katsuaki
authors.initials: K
authors.lastname: Tanaka
keywords: adverse drug reaction; age; dose; hepatocellular carcinoma; propensity score; sorafenib