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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

Sridhar Mani, Howard Hochster, Thomas Beck, et al.
Abramson Cancer Center of the University of Pennsylvania
Last Modified: November 1, 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

Introduction

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.

Method

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.

Results

• 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.

Discussion

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.