title: Combination therapy with S-1 and pegylated interferon alpha for advanced hepatocellular carcinoma.
abstract: OBJECTIVE
  There are currently no effective treatments for patients with advanced hepatocellular carcinoma (HCC) with vascular invasion or extrahepatic metastases. We evaluated the efficacy and safety of combination therapy with S-1 and pegylated interferon (PEG-IFN)-alpha for advanced HCC.
  
  
  METHODS
  A total of 22 patients received combination therapy with S-1 and PEG-IFN. One cycle of the combination therapy consists of oral S-1 (80 mg/m(2)) administration and subcutaneous PEG-IFN injection (PEG-IFN-alpha-2a 90 microg weekly or PEG-IFN-alpha-2b 50 microg weekly) for 4 weeks with 1- to 2-week intervals.
  
  
  RESULTS
  One patient was evaluated as complete response, 6 as partial response, 8 as stable disease, and 6 as progressive disease. One patient was not evaluable because therapy had to be discontinued as a result of jaundice. The median survival time was 15.3 months (95% CI: 4.4-26.2 months). The 1- and 2-year survival rates were 54.9 and 36.6%, respectively. The overall response rate was 31.8% and the disease control rate was 68.2%. Grade 3 neutropenia (18.2%), leukopenia (9.1%), anemia (9.1%), and thrombocytopenia (18.2%) were observed. Grade 4 toxicities were not observed.
  
  
  CONCLUSIONS
  Combination therapy with S-1 and PEG-IFN is effective and feasible, and is therefore a promising regimen for advanced HCC.
authors.affiliation: Department of Gastroenterology and Hepatology, Kinki University School of Medicine, Osaka-Sayama, Japan.
authors.forename: Kazuomi
authors.initials: K
authors.lastname: Ueshima
authors.forename: Masatoshi
authors.initials: M
authors.lastname: Kudo
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Nagai
authors.forename: Chie
authors.initials: C
authors.lastname: Tatsumi
authors.forename: Taisuke
authors.initials: T
authors.lastname: Ueda
authors.forename: Shunsuke
authors.initials: S
authors.lastname: Takahashi
authors.forename: Kinuyo
authors.initials: K
authors.lastname: Hatanaka
authors.forename: Satoshi
authors.initials: S
authors.lastname: Kitai
authors.forename: Emi
authors.initials: E
authors.lastname: Ishikawa
authors.forename: Tatsuo
authors.initials: T
authors.lastname: Inoue
authors.forename: Satoru
authors.initials: S
authors.lastname: Hagiwara
authors.forename: Yasunori
authors.initials: Y
authors.lastname: Minami
authors.forename: Hobyung
authors.initials: H
authors.lastname: Chung
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy*; D018450:Disease Progression; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008113:Liver Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage*; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011994:Recombinant Proteins; D016019:Survival Analysis; D005641:Tegafur / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D004338:Drug Combinations; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; C079198:S 1 (combination); D005641:Tegafur; D011092:Polyethylene Glycols; D010094:Oxonic Acid; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a