Twelves, C. et al. (2005) Capecitabine as adjuvant treatment for stage III colon cancer. New England Journal of Medicine, 352(26), pp. 2696-2704. (doi: 10.1056/NEJMoa043116)
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Abstract
BACKGROUND: Intravenous bolus fluorouracil plus leucovorin is the standard adjuvant treatment for colon cancer. The oral fluoropyrimidine capecitabine is an established alternative to bolus fluorouracil plus leucovorin as first-line treatment for metastatic colorectal cancer. We evaluated capecitabine in the adjuvant setting. METHODS: We randomly assigned a total of 1987 patients with resected stage III colon cancer to receive either oral capecitabine (1004 patients) or bolus fluorouracil plus leucovorin (Mayo Clinic regimen; 983 patients) over a period of 24 weeks. The primary efficacy end point was at least equivalence in disease-free survival; the primary safety end point was the incidence of grade 3 or 4 toxic effects due to fluoropyrimidines. RESULTS: Disease-free survival in the capecitabine group was at least equivalent to that in the fluorouracil-plus-leucovorin group (in the intention-to-treat analysis, P<0.001 for the comparison of the upper limit of the hazard ratio with the noninferiority margin of 1.20). Capecitabine improved relapse-free survival (hazard ratio, 0.86; 95 percent confidence interval, 0.74 to 0.99; P=0.04) and was associated with significantly fewer adverse events than fluorouracil plus leucovorin (P<0.001). CONCLUSIONS: Oral capecitabine is an effective alternative to intravenous fluorouracil plus leucovorin in the adjuvant treatment of colon cancer.
Item Type: | Articles |
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Status: | Published |
Refereed: | Yes |
Glasgow Author(s) Enlighten ID: | Cassidy, Professor James |
Authors: | Twelves, C., Wong, A., Nowacki, M., Abt, M., Burris, H., Carrato, A., Cassidy, J., Cervantes, A., Fagerberg, J., Georgoulias, V., Husseini, F., Jodrell, D., Koralewski, P., Kroning, H., Maroun, J., Marschner, N., McKendrick, J., Pawlicki, M., Rosso, R., Schuller, J., and Seitz, J. |
College/School: | College of Medical Veterinary and Life Sciences > School of Cancer Sciences |
Journal Name: | New England Journal of Medicine |
Publisher: | Massachusetts Medical Society |
ISSN: | 0028-4793 |
ISSN (Online): | 1533-4406 |
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