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Phase II Study of Uracil-Tegafur With Leucovorin in Elderly ( 75 years old) Patients With Colorectal Cancer: ECOG 1299

Howard S. Hochster, Weixiu Luo, Elizabeta C. Popa, Bruce T. Lyman, Mary Mulcahy, Peter A. Beatty, Al Bowen Benson

From the New York University Cancer Institute, New York; Capitol District Hematology/Oncology, Latham, NY; Dana-Farber Cancer Institute, Boston, MA; Northwestern University, Chicago, IL; and Meriter Hospital, Madison, WI

Address reprint requests to Howard S. Hochster, MD, New York University Cancer Institute, 160 E 34th St, New York, NY 10016; e-mail: howard.hochster{at}med.nyu.edu

Purpose To evaluate the tolerability and effectiveness of uracil-tegafur (UFT) with leucovorin (LV) in the treatment of elderly patients with advanced colorectal cancer.

Patients and Methods Patients 75 years of age with previously untreated colorectal cancer were eligible for this phase II, single-arm, open-label, multicenter cooperative group clinical trial. UFT 100 mg/m² plus LV 30 mg orally every 8 hours for 28 days every 35 days was administered until progression.

Results Fifty-eight patients were enrolled between June 2000 and July 2001, and 55 were treated. The median age of treated patients was 81 years (range, 75 to 90 years), 26 patients were (47%) women, and 80% had good performance status (0 to 1). The observed overall response rate was 22% (95% CI, 11.8% to 35.0%). The estimated median overall survival time was 13.0 months (95% CI, 9.6 to 17.4 months), and median progression-free survival time was 4.6 months (95% CI, 2.6 to 6.7 months). Among the 56 treated patients (including one ineligible patient), 31 (55%) experienced grade 3 to 4 toxicities, most commonly diarrhea (25%) and GI toxicity (36%), with patients older than 85 years of age at highest risk.

Conclusion The results of this trial support the efficacy of oral UFT/LV in elderly patients with colorectal cancer. The regimen is tolerated moderately well overall, particularly as compared with other fluoropyrimidine regimens, although there is increased GI toxicity in the most elderly. These results suggest that studies using newer oral fluoropyrimidine analogs should be investigated in this patient population.

Supported by Grants No. CA23318, 66636, 21115, 11083, 17145, 21076, and 16087 from the National Institutes of Health.

Presented in part at 41st Annual Meeting of the American Society of Clinical Oncology, May 13-17, 2005, Orlando, FL.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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