title: Combination therapy of oral fluoropyrimidine anticancer drug S-1 and interferon alpha for HCC patients with extrahepatic metastases.
abstract: OBJECTIVE
  There is no standard treatment for hepatocellular carcinoma (HCC) patients with extrahepatic metastases. We assessed the efficiency and safety of the oral fluoropyrimidine anticancer drug S-1 combined with interferon alpha (IFN-alpha) for HCC patients with extrahepatic metastases.
  
  
  METHODS
  Twenty-nine HCC patients with extrahepatic metastases received S-1/IFN. One cycle of combination therapy represented 2 weeks followed by 2-4 weeks of rest. In each cycle, S-1 was administrated orally at 80-120 mg (depending on body surface area) every day and IFN-alpha intramuscularly at 5 million units thrice weekly.
  
  
  RESULTS
  The overall response of 29 patients was complete response (CR) in 4 (14%), partial response (PR) in 1, stable disease in 4, progressive disease in 12, and dropout in 8 patients. Objective response (CR + PR) was 17%. The time to progression and survival rate were significantly higher in patients with lung metastases (n = 19) than in those with painful bone metastases (n = 7; p = 0.0058 and 0.0015). With regard to NCI-CTC grade 3 adverse reactions, 3 (10%), 3 (10%) and 2 (7%) patients developed anorexia, leukopenia, and neutropenia, respectively. No grade 4 adverse reaction or toxicity-related death occurred.
  
  
  CONCLUSIONS
  S-1/IFN is a potentially safe and suitable combination therapy for HCC patients with extrahepatic metastases, especially those with lung metastases.
authors: Programs for Biomedical Research, Division of Frontier Medical Science, Department of Medicine and Molecular Science, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima, Japan.
authors: Kiminori
authors: K
authors: Uka
authors: Hiroshi
authors: H
authors: Aikata
authors: Nami
authors: N
authors: Mori
authors: Shintaro
authors: S
authors: Takaki
authors: Yoshiiku
authors: Y
authors: Kawakami
authors: Takahiro
authors: T
authors: Azakami
authors: Tomokazu
authors: T
authors: Kawaoka
authors: Soo Cheol
authors: SC
authors: Jeong
authors: Shoichi
authors: S
authors: Takahashi
authors: Kazuaki
authors: K
authors: Chayama
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000556:secondary; D018450:Disease Progression; D004338:Drug Combinations; D005260:Female; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage; D012074:Remission Induction; D012189:Retrospective Studies; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D016898:Interferon-alpha; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid