title: Therapeutic efficacy of combination therapy with intra-arterial 5-fluorouracil and systemic pegylated interferon α-2b for advanced hepatocellular carcinoma with portal venous invasion.
abstract: BACKGROUND
  The prognosis of advanced hepatocellular carcinoma (HCC) remains poor, particularly among patients with portal vein tumor thrombosis (PVTT). This study evaluated the efficacy of combined 5-fluorouracil and pegylated interferon (PEG-IFN) α-2b in patients with advanced HCC.
  
  
  METHODS
  Subjects comprised 59 HCC patients with PVTT treated using subcutaneous administration of PEG-IFNα-2b (50-100 μg on day 1 of each week for 4 weeks) and intra-arterial infusion of 5-fluorouracil (250 mg/d for 5 hours on days 1-5 of each week for 4 weeks). One treatment cycle lasted 4 weeks. The current therapy was discontinued in patients with progressive disease (PD). For responses other than PD, treatment was repeated for ≥1 cycle. The primary efficacy endpoint was the objective early response rate. Secondary efficacy endpoints were progression-free survival (PFS) and overall survival.
  
  
  RESULTS
  Objective early response rate was 73.0%. Cumulative PFS rates were 67.4% at 6 months, 30.2% at 12 months, 25.9% at 18 months, and 20.7% at 24 months. Median PFS was 9.7 months. Cumulative survival rates were 82.4% at 6 months, 73.6% at 12 months, 52.8% at 24 months, and 44.0% at 36 months. Median survival time was 29.9 months. All adverse reactions were controllable by temporary suspension of treatment. Serious complications and treatment-related deaths were not observed.
  
  
  CONCLUSIONS
  Although a prospective randomized controlled trial using a larger population of patients with advanced HCC is needed to evaluate combination therapy with 5-fluorouracil and PEG-IFNα-2b, this new combination therapy may be useful for patients with advanced HCC.
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Iwate Medical University, Morioka, Iwate, Japan. kaz-k@yc4.so-net.ne.jp
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Kasai
authors.forename: Akira
authors.initials: A
authors.lastname: Ushio
authors.forename: Yukiho
authors.initials: Y
authors.lastname: Kasai
authors.forename: Kei
authors.initials: K
authors.lastname: Sawara
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Miyamoto
authors.forename: Kanta
authors.initials: K
authors.lastname: Oikawa
authors.forename: Hidekatsu
authors.initials: H
authors.lastname: Kuroda
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Takikawa
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Suzuki
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage*; D006801:Humans; D007261:Infusions, Intra-Arterial; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011169:Portal Vein; D011379:Prognosis; D011994:Recombinant Proteins / Q000008:administration & dosage; D015996:Survival Rate; D020246:Venous Thrombosis / Q000150:complications*
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C417083:peginterferon alfa-2b; D005472:Fluorouracil