IngentaConnect Oral eniluracil5-fluorouracil in patients with inoperable hepatoc...

Authors: Hohneker J.⁶; Benson III A.B.¹; Mitchell E.²; Abramson N.³; Klencke B.⁴; Ritch P.⁵; Burnham J.P.⁶; McGuirt C.⁶; Bonny T.⁶; Levin J.⁶

Source: Annals of Oncology, Volume 13, Number 4, 26 April 2002 , pp. 576-581(6)

Publisher: Oxford University Press

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.

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