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Previous Volume 352:2696-2704 June 30, 2005 Number 26 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Allegra, C. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

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.

Source Information

From the University of Leeds and Bradford NHS Hospitals' Trust, Leeds, and Cancer Research U.K., Department of Medical Oncology, University of Glasgow, Glasgow, United Kingdom (C.T.); Tom Baker Cancer Centre, Calgary, Alta., Canada (A.W.); Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland (M.P.N.); Hoffmann–La Roche, Basel, Switzerland (M.A., J.F.); Sarah Cannon Cancer Center, Nashville (H.B.); Hospital General de Elche, Elche, Alicante, Spain (A. Carrato); Cancer Research U.K., Department of Medical Oncology, University of Glasgow, Glasgow, and Department of Medicine and Therapeutics, University of Aberdeen, Aberdeen — both in the United Kingdom (J.C.); Hospital Clínico, Valencia, Spain (A. Cervantes); University Hospital of Crete, Heraklion, Greece (V.G.); Hôpital Pasteur, Colmar, France (F.H.); University of Edinburgh, Edinburgh, United Kingdom (D.J.); Rydygier Memorial Hospital, Krakow–Nowa Huta, Poland (P.K.); Städisches Klinikum Magdeburg, Magdeburg, Germany (H.K.); Ottawa Regional Cancer Centre, Ottawa (J. Maroun); Outpatient Cancer Center, Freiburg, Germany (N.M.); Box Hill Hospital, Melbourne, Australia (J. McKendrick); Cancer Institute, Krakow, Poland (M.P.); Instituto Nazionale per la Ricerca sul Cancro, Genoa, Italy (R.R.); Krankenanstalt Rudolfstiftung, Vienna (J.S.); Hôpital La Timone, Marseille, France (J.-F.S.); Klinicni Center Ljubljana, Ljubljana, Slovenia (B.S.); Regional Center of Oncology, Bydgoszcz, Poland (J.T.); Perth Oncology, Mount Hospital, West Perth, Australia (G.V.H.); Great Poland Cancer Center, Poznan, Poland (J.Z.); and Allgemeines KrankenHaus-Universität Kliniken Wien, Vienna (W.S.).

Address reprint requests to Dr. Twelves at the Tom Connors Cancer Research Centre, University of Bradford, Richmond Road, Bradford BD7 1DP, United Kingdom, or at c.twelves{at}bradford.ac.uk.

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