title: Higher discontinuation and lower survival rates are likely in elderly Japanese patients with advanced hepatocellular carcinoma receiving sorafenib.
abstract: OBJECTIVE
  Sorafenib is approved for the treatment of advanced hepatocellular carcinoma (HCC) in Japan; however, its tolerability and efficacy in elderly patients with HCC have not been clarified. We aimed to evaluate the tolerability and efficacy of sorafenib with increasing age.
  
  
  METHODS
  As part of a retrospective, multicenter cohort study conducted between May 2009 and February 2010, patients with advanced HCC received 400 mg sorafenib twice daily (standard dosage) or once daily (half-dosage) until disease progression or treatment intolerance.
  
  
  RESULTS
  The mean age of the enrolled patients (n = 76) was 70.3 years, and 24 of them were ≥75 years old. The prognostic factors for survival were age < 75 years, performance status score zero, α-fetoprotein level < 1000 ng/mL, des-gamma-carboxy prothrombin level < 1000 ng/mL, and treatment duration ≥ 1 month. The median treatment duration and overall incidence of adverse drug reactions (ADRs) were not statistically different with increasing age. However, subgroup analysis revealed that treatment discontinuation because of ADRs was more frequent among the ≥75-year-old patients (41.7%) than among the <75-year-old ones (15.0%) with the standard dosage (P = 0.047); this trend was not observed among those who received the half-dose regimen.
  
  
  CONCLUSIONS
  Sorafenib has modest efficacy and acceptable toxicity in younger (<75 years) patients with HCC; however, elderly patients experience some side effects when it is administered at the standard dosage.
authors.affiliation: Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Kanagawa, Japan. morimoto@urahp.yokohama-cu.ac.jp
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: Hisashi
authors.initials: H
authors.lastname: Hidaka
authors.forename: Juichi
authors.initials: J
authors.lastname: Takada
authors.forename: Akitaka
authors.initials: A
authors.lastname: Shibuya
authors.forename: Satoshi
authors.initials: S
authors.lastname: Kobayashi
authors.forename: Shinichi
authors.initials: S
authors.lastname: Ohkawa
authors.forename: Chiaki
authors.initials: C
authors.lastname: Okuse
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