Multicenter Phase II Study to Evaluate a 28-Day Regimen of Oral Fluorouracil Plus Eniluracil in the Treatment of Patients with Previously Untreated Metastatic Colorectal Cancer

Author: Sridhar Mani, Howard Hochster, Thomas Beck, et al.
Content Contributor: Abramson Cancer Center of the University of Pennsylvania
Last Reviewed: November 01, 2001

Reviewers: Li Liu, MD
Source: Journal of Clinical Oncology, Volume 18:2894-2901, (August) 2000

Précis: Oral fluorouracil plus eniluracil is effective in treating metastatic colon cancer


Fluorouracil (5-FU) has been a mainstay of therapy for the treatment of metastatic colorectal cancer, despite modest response rates of approximately 20% on conventional bolus administration schedules. Some phase I studies have demonstrated that the combination of oral 5-FU plus eniluracil provides a cost-effective and convenient alternative to protracted IV infusion therapy in patients with metastatic colorectal cancer (Journal of Clinical Oncology 2000 Feb; 18(4): 915-26). In this phase II study, the researchers assessed the efficacy of oral 5-FU plus eniluracil in patients with metastatic colon cancer.


A total of 55 patients with previously untreated metastatic colorectal cancer received oral eniluracil plus one of two dose levels of oral 5-FU twice a day for 28 days, which was repeated every 5 weeks.

  • A partial response was observed in 25% of all treated patients with a median response duration of 23.9 weeks.
  • 36% of patients had stable disease for a median duration of 24.1 weeks.
  • Median progression-free and overall survival was 22.6 weeks and 59 weeks, respectively.
  • The response rates of the two dose level groups were similar.

This phase II study demonstrated that oral 5-FU taken with eniluracil was well tolerated and comparable to intravenous treatment for metastatic colorectal cancer in terms of efficacy. We have to wait for the results of a phase III study in order to know if this is truly as effective as conventional treatment.

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