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Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 3508
© 2004 American Society of Clinical Oncology
A phase III trial comparing oral UFT to FULV in stage II and III carcinoma of the colon: Results of NSABP Protocol C-06
N. Wolmark,
S. Wieand,
B. Lembersky,
L. Colangelo,
R. Smith and
R. Pazdur
NSABP, Pittsburgh, PA; FDA, Rockville, MD
3508
Background: The primary aim of this two-arm randomized prospective study was to compare the relative efficacy of oral UFT+LV with that of FULV in prolonging disease-free survival (DFS) and survival (S). Methods: Between February 1997 and March 1999, 1,608 patients (805 and 803 in each arm) with stage II and III carcinoma of the colon were randomized to receive either oral UFT+LV (tegafur, 300 mg/m2/day and uracil in a 1:4 molar ratio p.o. x 28 days; leucovorin 90 mg/day p.o. x 28 days, each 35 day cycle x 5) or FULV (5-FU, 500 mg/m2 iv bolus weekly x 6; LV, 500 mg/m2 iv weekly x 6, each 8 week cycle x 3 Results: With a mean time on study of 64 months for patients with follow-up there were no significant differences in disease-free survival or overall survival between the two treatment arms. Results (%) at 5 years were:
The two regimens were equitoxic and well tolerated. The Fact C quality of life metric disclosed no significant difference; other secondary quality of life measurements during chemotherapy administration appeared to favor UFT. Conclusion: Oral UFT + LV achieved equivalent DFS and S when compared to iv FULV in patients with stage II and III carcinoma of the colon.
No significant financial relationships to disclose.
Abstract presentation from the 2004 ASCO Annual Meeting
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