title: 5-fluorouracil arterial infusion + interferon therapy for highly advanced hepatocellular carcinoma: A multicenter, randomized, phase II study.
abstract: OBJECTIVE
  The efficacy and safety of 5-fluorouracil arterial infusion + interferon therapy (FAIT) was evaluated in patients with hepatocellular carcinoma (HCC) with a high degree of vascular invasion associated with poor prognosis, using best salvage therapy (BST) as a reference group.
  
  
  METHODS
  Sixty-nine patients with advanced HCC with a high degree of vascular invasion (Vp3, Vp4, Vv3) were randomly assigned to a FAIT group or a BST group. The FAIT group received interferon-α and 5-fluorouracil combination therapy; the BST group received either combination therapy of cisplatin and 5-fluorouracil (low-dose FP therapy) or cisplatin for arterial infusion.
  
  
  RESULTS
  Thirty patients in the FAIT group and 31 patients in the BST group were included in the efficacy analysis. The response rate (primary endpoint) was 26.7% (eight out of 30 patients) for the FAIT group and 25.8% (eight out of 31) for the BST group. The number of occurrences of adverse events of grade 3 or higher was 115 in 30 patients in the FAIT group and 113 in 29 patients in the BST group. None of the deaths were related to the study therapy.
  
  
  CONCLUSIONS
  FAIT exerts modest antitumor effects and poses no particular safety concerns. FAIT may be a strategy of choice worth trying for advanced HCC with high degree of vascular invasion, which is associated with poor prognosis.
authors: Osaka University, Suita, Osaka             Nishinomiya Municipal Central Hospital, Nishinomiya, Hyogo             Misawa City Hospital, Misawa, Aomori             Otsuka Pharmaceutical Co., Ltd., Osaka, Osaka, Japan.
authors: Morito
authors: M
authors: Monden
authors: Masato
authors: M
authors: Sakon
authors: Yuh
authors: Y
authors: Sakata
authors: Yoshitaka
authors: Y
authors: Ueda
authors: Etsuro
authors: E
authors: Hashimura