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

Identifieur interne : 00AB60 ( Main/Exploration ); précédent : 00AB59; suivant : 00AB61

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

Auteurs : Thierry Andre [France] ; Corrado Boni [Italie] ; Lamia Mounedji-Boudiaf [France] ; Matilde Navarro [Espagne] ; Josep Tabernero [Espagne] ; Tamas Hickish [Royaume-Uni] ; Clare Topham [Royaume-Uni] ; Marta Zaninelli [Italie] ; Philip Clingan [Australie] ; John Bridgewater [Royaume-Uni] ; Isabelle Tabah-Fisch [France] ; Aimery De Gramont [France]

Source :

RBID : Pascal:04-0317626

Descripteurs français

English descriptors

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.


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Le document en format XML

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<title xml:lang="en" level="a">Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer</title>
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<name sortKey="Hickish, Tamas" sort="Hickish, Tamas" uniqKey="Hickish T" first="Tamas" last="Hickish">Tamas Hickish</name>
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<name sortKey="Topham, Clare" sort="Topham, Clare" uniqKey="Topham C" first="Clare" last="Topham">Clare Topham</name>
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<name sortKey="Clingan, Philip" sort="Clingan, Philip" uniqKey="Clingan P" first="Philip" last="Clingan">Philip Clingan</name>
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<wicri:noRegion>Medical Day Care Centre</wicri:noRegion>
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<name sortKey="Bridgewater, John" sort="Bridgewater, John" uniqKey="Bridgewater J" first="John" last="Bridgewater">John Bridgewater</name>
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<name sortKey="Tabah Fisch, Isabelle" sort="Tabah Fisch, Isabelle" uniqKey="Tabah Fisch I" first="Isabelle" last="Tabah-Fisch">Isabelle Tabah-Fisch</name>
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<country>France</country>
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<region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
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<name sortKey="De Gramont, Aimery" sort="De Gramont, Aimery" uniqKey="De Gramont A" first="Aimery" last="De Gramont">Aimery De Gramont</name>
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<country>France</country>
<placeName>
<region type="region">Île-de-France</region>
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<series>
<title level="j" type="main">The New England journal of medicine</title>
<title level="j" type="abbreviated">N. Engl. j. med.</title>
<idno type="ISSN">0028-4793</idno>
<imprint>
<date when="2004">2004</date>
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<title level="j" type="main">The New England journal of medicine</title>
<title level="j" type="abbreviated">N. Engl. j. med.</title>
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<keywords scheme="KwdEn" xml:lang="en">
<term>Adjuvant treatment</term>
<term>Calcium folinate</term>
<term>Colon cancer</term>
<term>Fluorouracil</term>
<term>Medicine</term>
<term>Oxaliplatin</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Oxaliplatine</term>
<term>Fluorouracil</term>
<term>Folinate de calcium</term>
<term>Traitement adjuvant</term>
<term>Médecine</term>
<term>Cancer du côlon</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr">
<term>Médecine</term>
</keywords>
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<front>
<div type="abstract" xml:lang="en">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.</div>
</front>
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<li>Australie</li>
<li>Espagne</li>
<li>France</li>
<li>Italie</li>
<li>Royaume-Uni</li>
</country>
<region>
<li>Angleterre</li>
<li>Catalogne</li>
<li>Grand Londres</li>
<li>Île-de-France</li>
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<li>Barcelone</li>
<li>Londres</li>
<li>Paris</li>
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<name sortKey="Topham, Clare" sort="Topham, Clare" uniqKey="Topham C" first="Clare" last="Topham">Clare Topham</name>
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<country name="Australie">
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