Author/Editor		Twelves, Chris; Wong, Alfred; Nowacki, Marek P; Abt, Markus; Burris, Howard; Carrato, Alfredo; Cassidy, Jim; Cervantes, Andres; Fagerberg, Jan; Štabuc, Borut
Title		Capecitabine as adjuvant treatment for stage III colon cancer
Type		članek
Source		N Engl J Med
Vol. and No.		Letnik 352, št. 26
Publication year		2005
Volume		str. 2696-704
Language		eng
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.
Descriptors		COLONIC NEOPLASMS ANTIMETABOLITES, ANTINEOPLASTIC CHEMOTHERAPY, ADJUVANT DEOXYCYTIDINE NEOPLASM STAGING AGE FACTORS SEX FACTORS DISEASE-FREE SURVIVAL SURVIVAL ANALYSIS MULTIVARIATE ANALYSIS