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Annals of Oncology 13:576-581, 2002
© 2002 European Society for Medical Oncology

Original Paper

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

A. B. Benson III1,+, E. Mitchell2, N. Abramson3, B. Klencke4, P. Ritch5, J. P. Burnham6, C. McGuirt6, T. Bonny6, J. Levin6 and J. Hohneker6

1Northwestern University, Chicago, IL; 2Thomas Jefferson University, Philadelphia, PA; 3Baptist Regional Cancer Institute, Jacksonville, FL; 4The Medical Center at the University of California San Francisco, San Francisco, CA; 5Medical College of Wisconsin, Milwaukee, WI; 6Glaxo Wellcome, Research Triangle Park, NC, USA

Received 22 January 2001; revised 17 September 2001; accepted 4 October 2001.

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.

Key words: chemotherapy, dihydropyrimidine dehydrogenase, eniluracil, 5-fluorouracil,inoperable hepatocellular carcinoma


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