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, Eric M. Chevlen, Mark A. O'Rourke, Charles H. Weaver, William N. Bell, Robin White, Chip McGuirt, Jeremey Levin, John Hohneker, Richard L. Schilsky, Jacob Lokich

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33 Scopus citations

Abstract

Purpose: To determine the efficacy of fluorouracil (5-FU) plus eniluracil when administered to patients with previously untreated metastatic colorectal cancer. Patients and Methods: In this single-arm phase II study, patients with previously untreated metastatic colorectal cancer received oral eniluracil plus 5-FU (10:1 dose ratio), at 5-FU doses of 1.00 mg/m2 or 1.15 mg/m2 twice daily (every 12 hours) for 28 consecutive days repeated every 5 weeks (one cycle). Treatment continued until there was documented disease progression or unacceptable toxicity. Results: Thirty and 25 patients were enrolled at a starting dose of 1.00 mg/m2 and 1.15 and mg/m2, respectively. Fourteen (25%) of 55 patients (95% confidence interval, 15% to 39%) had a partial response, and 20 patients (36%) had stable disease. The median durations of the partial responses and stable disease were 23.9 weeks (range, 12.3 to 52.1+ weeks) and 24.1 weeks (range, 17.1 to 55.6+ weeks), respectively. The median durations of progression-free and overall survival were 22.6 weeks (range, 21.0 to 29.0 weeks) and 59 weeks (range, 4 to 84+ weeks), respectively. The response rate in the 1.15 mg/m2-dose group was similar to the 1.00 mg/m2-dose group (28% v 23%, respectively). Severe (grade 3/4) nonhematologic treatment-related toxicity included diarrhea (nine patients), nausea/vomiting (one patient each), mucositis (two patients), and anorexia (one patient). Severe hematologic toxicities were rare. At the 1.15 mg/m2-dose level, two patients exhibited grade 3 granulocytopenia, and two patients had grade 3 anemia. Conclusion: The response rate with oral 5-FU plus eniluracil is comparable with that observed with infusional 5-FU or bolus 5-FU and leucovorin. The toxicity profile of this oral regimen is acceptable for use in an outpatient home-based setting. (C) 2000 by American Society of Clinical Oncology.

Original languageEnglish (US)
Pages (from-to)2894-2901
Number of pages8
JournalJournal of Clinical Oncology
Volume18
Issue number15
DOIs
StatePublished - Jan 1 2000
Externally publishedYes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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