title: Randomized, phase II study comparing interferon combined with hepatic arterial infusion of fluorouracil plus cisplatin and fluorouracil alone in patients with advanced hepatocellular carcinoma.
abstract: OBJECTIVE
  This randomized phase II trial compared the response rates to treatment with interferon (IFN) combined with hepatic arterial infusion of fluorouracil (FU) plus cisplatin (CDDP) or FU alone in patients with advanced hepatocellular carcinoma (HCC).
  
  
  METHODS
  A total of 114 patients with measurable advanced HCC were enrolled and randomized into 2 groups. FU (300 mg/m(2), days 1-5, days 8-12) with or without CDDP (20 mg/m(2), days 1 and 8) was administered via the hepatic artery. IFNα-2b was administered 3 times per week for 4 weeks.
  
  
  RESULTS
  The response rates were 45.6% for the IFN/FU + CDDP group and 24.6% for the IFN/FU group. The response rate was significantly higher in the IFN/FU + CDDP group (p = 0.030). The median overall survival period was 17.6 months in the IFN/FU + CDDP group versus 10.5 months in the IFN/FU group (p = 0.522). The median progression-free survival period was 6.5 months in the IFN/FU + CDDP group versus 3.3 months in the IFN/FU group (p = 0.0048). Hematological toxicity was common, but no toxicity-related deaths were observed.
  
  
  CONCLUSIONS
  These results show the clinical efficacy of adding CDDP to the hepatic arterial infusion of FU in combined chemotherapy regimens with IFN.
authors: Department of Gastroenterology, Kanazawa University, Kanazawa, Japan. ytatsuya@m-kanazawa.jp
authors: Tatsuya
authors: T
authors: Yamashita
authors: Kuniaki
authors: K
authors: Arai
authors: Hajime
authors: H
authors: Sunagozaka
authors: Teruyuki
authors: T
authors: Ueda
authors: Takeshi
authors: T
authors: Terashima
authors: Taro
authors: T
authors: Yamashita
authors: Eishiro
authors: E
authors: Mizukoshi
authors: Akito
authors: A
authors: Sakai
authors: Yasunari
authors: Y
authors: Nakamoto
authors: Masao
authors: M
authors: Honda
authors: Shuichi
authors: S
authors: Kaneko
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*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007261:Infusions, Intra-Arterial / Q000379:methods; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects; D008113:Liver Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged
chemical_list: D016898:Interferon-alpha; D002945:Cisplatin; D005472:Fluorouracil