Capecitabine as adjuvant treatment for stage III colon cancer

C Twelves, A Wong, M P Nowacki, M Abt, H Burris, A Carrato, J Cassidy, A Cervantes, J Fagerberg, V Georgoulias, F Husseini, D Jodrell, P Koralewski, H Kroning, J Maroun, N Marschner, J McKendrick, M Pawlicki, R Rosso, J SchullerJ F Seitz, B Stabuc, J Tujakowski, G Van Hazel, J Zaluski, W Scheithauer

Research output: Contribution to journalArticlepeer-review



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.


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.


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).


Oral capecitabine is an effective alternative to intravenous fluorouracil plus leucovorin in the adjuvant treatment of colon cancer.

Original languageEnglish
Pages (from-to)2696-2704
Number of pages9
JournalNew England Journal of Medicine
Issue number26
Publication statusPublished - 30 Jun 2005


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