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Annals of Oncology 13:1576-1582, 2002
© 2002 European Society for Medical Oncology

Original Paper

Phase II trial of 5-fluorouracil plus eniluracil in patients with advanced pancreatic cancer: a Southwest Oncology Group study

M. L. Rothenberg1,+, J. K. Benedetti2, J. S. Macdonald3, T. E. Seay4, M. A. Neubauer5, C. S. George6, M. S. Tanaka7, J. K. Giguere8, B. T. Pruitt9 and J. L. Abbruzzese10,§

1 Vanderbilt University Medical Center, Nashville, TN; 2 Southwest Oncology Group Statistical Center, Seattle, WA; 3 St Vincent’s Comprehensive Cancer Center, New York, NY; 4 Atlanta Regional Community Clinical Oncology Program, Atlanta, GA; 5 Kansas City Community Clinical Oncology Program, Kansas City, MO; 6 Columbus Community Clinical Oncology Program, Columbus, OH; 7 University of California, Davis, Sacramento, CA; 8 Greenville Community Clinical Oncology Program, Greenville, SC; 9 Don and Sybil Harrington Cancer Center, Amarillo, TX; 10 University of Texas, M.D. Anderson Cancer Center, Houston, TX, USA

Received 31 January 2002; revised 4 April 2002; accepted 24 April 2002

Background:

Eniluracil is a potent, irreversible inactivator of dihydropyrimidine dehydrogenase, the major catabolic enzyme for 5-fluorouracil (5-FU). Pretreatment with eniluracil significantly increases plasma half-life, plasma concentration and oral bioavailability of 5-FU. This multicenter phase II trial was designed to estimate the 6-month survival rate in patients with metastatic adenocarcinoma of the pancreas treated with 5-FU and eniluracil.

Patients and methods:

One hundred and sixteen patients (61 with no prior chemotherapy and 55 with prior chemotherapy) were registered for treatment with eniluracil 50 mg (total dose) p.o. on days 1–7 and 5-FU 20 mg/m2/day p.o. on days 2–6 of a 28-day treatment cycle.

Results:

In 106 patients evaluable for survival, the 6-month survival rate was 34% [95% confidence interval (CI) 22% to 47%, median survival 3.6 months] for patients who had not been treated previously with chemotherapy and 29% (95% CI 16% to 42%, median survival 3.4 months) for those who had received prior chemotherapy. For those patients with measurable disease, the confirmed response rates were 8% and 2%, respectively. The most common grade 3–4 toxicities were neutropenia (29% of patients) and diarrhea (12% of patients). Overall, 69% of patients experienced a grade 3 or worse adverse event during treatment.

Conclusions:

These results suggest that the combination of a 7-day course of eniluracil and a 5-day course of oral 5-FU has limited activity in patients with advanced pancreatic cancer, and is associated with a high frequency of clinically significant adverse events.

Key words: 5-fluorouracil, clinical trial, eniluracil, oral chemotherapy, pancreatic cancer, phase II


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