Oral eniluracil/5-fluorouracil in patients with inoperable hepatocellular carcinoma

A. B. Benson*, E. Mitchell, N. Abramson, B. Klencke, P. Ritch, J. P. Burnham, C. McGuirt, T. Bonny, J. Levin, J. Hohneker

*Corresponding author for this work

Research output: Contribution to journalArticle

15 Scopus citations

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. Patients and 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.

Original languageEnglish (US)
Pages (from-to)576-581
Number of pages6
JournalAnnals of Oncology
Volume13
Issue number4
DOIs
StatePublished - Apr 2002

Keywords

  • 5-fluorouracil
  • Chemotherapy
  • Dehydrogenase
  • Dihydropyrimidine
  • Inoperable hepatocellular carcinoma

ASJC Scopus subject areas

  • Hematology
  • Oncology

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    Benson, A. B., Mitchell, E., Abramson, N., Klencke, B., Ritch, P., Burnham, J. P., McGuirt, C., Bonny, T., Levin, J., & Hohneker, J. (2002). Oral eniluracil/5-fluorouracil in patients with inoperable hepatocellular carcinoma. Annals of Oncology, 13(4), 576-581. https://doi.org/10.1093/annonc/mdf079