title: Oral eniluracil/5-fluorouracil in patients with inoperable hepatocellular carcinoma.
abstract: BACKGROUND
  Conventional systemic chemotherapy currently available for patients with inoperable hepatocellular carcinoma is ineffective. The purpose of this study was to evaluate the safety and efficacy of eniluracil/5-fluorouracil (5-FU) in the treatment of patients with this highly refractory disease.
  
  
  METHODS
  This multicenter, open-label study evaluated a 28-day oral regimen of 5-FU (1 mg/m2 twice daily) plus the dihydropyrimidine dehydrogenase inhibitor, eniluracil (10 mg/m2 twice daily), in patients with chemotherapy-naive or anthracycline-refractory inoperable hepatocellular carcinoma.
  
  
  RESULTS
  A total of 36 patients enrolled into the study. No patient showed a confirmed partial or complete tumor response, although nine patients (25%) had a best response of stable disease. The median duration of progression-free survival was 9.6 weeks [95% confidence interval (CI) 9.1-10.6 weeks], and the median duration of overall survival was 32.7 weeks (95% CI 17.4-71.6 weeks). Eniluracil/5-FU was well tolerated. Diarrhea, the most frequent treatment-related non-hematological toxicity, occurred in 11 patients (31%). Hematological toxicities were infrequent and usually mild.
  
  
  CONCLUSIONS
  Eniluracil/5-FU as a 28-day oral outpatient regimen is well tolerated by patients with inoperable hepatocellular carcinoma, although minimal activity was observed when given as monotherapy at the dose used in this study.
authors.affiliation: Division of Hematology/Oncology, Northwestern University, Chicago, IL 60611, USA. a-benson@northwestern.edu
authors.forename: A B
authors.initials: AB
authors.lastname: Benson
authors.forename: E
authors.initials: E
authors.lastname: Mitchell
authors.forename: N
authors.initials: N
authors.lastname: Abramson
authors.forename: B
authors.initials: B
authors.lastname: Klencke
authors.forename: P
authors.initials: P
authors.lastname: Ritch
authors.forename: J P
authors.initials: JP
authors.lastname: Burnhan
authors.forename: C
authors.initials: C
authors.lastname: McGuirt
authors.forename: T
authors.initials: T
authors.lastname: Bonny
authors.forename: J
authors.initials: J
authors.lastname: Levin
authors.forename: J
authors.initials: J
authors.lastname: Hohneker
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000473:pathology; D003967:Diarrhea / Q000139:chemically induced; D004791:Enzyme Inhibitors / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014498:Uracil / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: D004791:Enzyme Inhibitors; C073482:eniluracil; D014498:Uracil; D005472:Fluorouracil