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Previous Volume 350:2343-2351 June 3, 2004 Number 23 Next

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

ABSTRACT

Background The standard adjuvant treatment of colon cancer is fluorouracil plus leucovorin (FL). Oxaliplatin improves the efficacy of this combination in patients with metastatic colorectal cancer. We evaluated the efficacy of treatment with FL plus oxaliplatin in the postoperative adjuvant setting.

Methods We randomly assigned 2246 patients who had undergone curative resection for stage II or III colon cancer to receive FL alone or with oxaliplatin for six months. The primary end point was disease-free survival.

Results A total of 1123 patients were randomly assigned to each group. After a median follow-up of 37.9 months, 237 patients in the group given FL plus oxaliplatin had had a cancer-related event, as compared with 293 patients in the FL group (21.1 percent vs. 26.1 percent; hazard ratio for recurrence, 0.77; P=0.002). The rate of disease-free survival at three years was 78.2 percent (95 percent confidence interval, 75.6 to 80.7) in the group given FL plus oxaliplatin and 72.9 percent (95 percent confidence interval, 70.2 to 75.7) in the FL group (P=0.002 by the stratified log-rank test). In the group given FL plus oxaliplatin, the incidence of febrile neutropenia was 1.8 percent, the incidence of gastrointestinal adverse effects was low, and the incidence of grade 3 sensory neuropathy was 12.4 percent during treatment, decreasing to 1.1 percent at one year of follow-up. Six patients in each group died during treatment (death rate, 0.5 percent).

Conclusions Adding oxaliplatin to a regimen of fluorouracil and leucovorin improves the adjuvant treatment of colon cancer.

Source Information

From Hôpital Tenon, Paris (T.A.); GERCOR Oncology Multidisciplinary Group, Paris (T.A., A.G.); Arcispedale Santa Maria Nuova, Reggio Emilia, Italy (C.B.); Sanofi-Synthelabo, Paris (L.M.-B., I.T.-F.); Hospital Duran i Reynals, l'Hospitalet de Llobregat, Llobregat, Spain (M.N.); Vall d'Hebron University Hospital, Barcelona, Spain (J.T.); Dorset Cancer Centre, Royal Bournemouth and Poole Hospitals, Bournemouth, United Kingdom (T.H.); Royal Surrey County Hospital, Guildford, Surrey, United Kingdom (C.T.); Ospedale Borgotrento, Verona, Italy (M.Z.); Southern Medical Day Care Centre, Wollongong, Australia (P.C.); North Middlesex Hospital, London (J.B.); and Hôpital Saint-Antoine, Paris (A.G.).

Address reprint requests to Dr. de Gramont at Hôpital Saint Antoine, 184 rue du Faubourg Saint Antoine, Paris 75012, France, or at aimery.de-gramont{at}sat.ap-hop-paris.fr.

Full Text of this Article

Related Letters:

Oxaliplatin in Colon Cancer
Mandalà M., Ferretti G., Barni S., de Gramont A., André T., Hickish T.
Extract | Full Text | PDF  
N Engl J Med 2004; 351:1691-1692, Oct 14, 2004. Correspondence

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