Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer

Thierry André, Corrado Boni, Lamia Mounedji-Boudiaf, Matilde Navarro, Josep Tabernero, Tamas Hickish, Clare Topham, Marta Zaninelli, Philip Clingan, John Bridgewater, Isabelle Tabah-Fisch, Aimery De Gramont

Research output: Contribution to journalArticle

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 oxatiplatin 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 gastro-intestinal 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.

Original languageEnglish
Pages (from-to)2343-2351
Number of pages9
JournalNew England Journal of Medicine
Volume350
Issue number23
DOIs
Publication statusPublished - Jun 3 2004

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oxaliplatin
Leucovorin
Fluorouracil
Colonic Neoplasms
Therapeutics
Disease-Free Survival
Incidence
Confidence Intervals
Febrile Neutropenia

ASJC Scopus subject areas

  • Medicine(all)

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André, T., Boni, C., Mounedji-Boudiaf, L., Navarro, M., Tabernero, J., Hickish, T., ... De Gramont, A. (2004). Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. New England Journal of Medicine, 350(23), 2343-2351. https://doi.org/10.1056/NEJMoa032709

Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. / André, Thierry; Boni, Corrado; Mounedji-Boudiaf, Lamia; Navarro, Matilde; Tabernero, Josep; Hickish, Tamas; Topham, Clare; Zaninelli, Marta; Clingan, Philip; Bridgewater, John; Tabah-Fisch, Isabelle; De Gramont, Aimery.

In: New England Journal of Medicine, Vol. 350, No. 23, 03.06.2004, p. 2343-2351.

Research output: Contribution to journalArticle

André, T, Boni, C, Mounedji-Boudiaf, L, Navarro, M, Tabernero, J, Hickish, T, Topham, C, Zaninelli, M, Clingan, P, Bridgewater, J, Tabah-Fisch, I & De Gramont, A 2004, 'Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer', New England Journal of Medicine, vol. 350, no. 23, pp. 2343-2351. https://doi.org/10.1056/NEJMoa032709
André T, Boni C, Mounedji-Boudiaf L, Navarro M, Tabernero J, Hickish T et al. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. New England Journal of Medicine. 2004 Jun 3;350(23):2343-2351. https://doi.org/10.1056/NEJMoa032709
André, Thierry ; Boni, Corrado ; Mounedji-Boudiaf, Lamia ; Navarro, Matilde ; Tabernero, Josep ; Hickish, Tamas ; Topham, Clare ; Zaninelli, Marta ; Clingan, Philip ; Bridgewater, John ; Tabah-Fisch, Isabelle ; De Gramont, Aimery. / Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. In: New England Journal of Medicine. 2004 ; Vol. 350, No. 23. pp. 2343-2351.
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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 oxatiplatin 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 gastro-intestinal 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.",
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T1 - Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer

AU - André, Thierry

AU - Boni, Corrado

AU - Mounedji-Boudiaf, Lamia

AU - Navarro, Matilde

AU - Tabernero, Josep

AU - Hickish, Tamas

AU - Topham, Clare

AU - Zaninelli, Marta

AU - Clingan, Philip

AU - Bridgewater, John

AU - Tabah-Fisch, Isabelle

AU - De Gramont, Aimery

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N2 - 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 oxatiplatin 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 gastro-intestinal 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.

AB - 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 oxatiplatin 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 gastro-intestinal 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.

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