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J Clin Oncol. 2018 May 20;36(15):1469-1477. doi: 10.1200/JCO.2017.76.0355. Epub 2018 Apr 5.

Three Versus 6 Months of Oxaliplatin-Based Adjuvant Chemotherapy for Patients With Stage III Colon Cancer: Disease-Free Survival Results From a Randomized, Open-Label, International Duration Evaluation of Adjuvant (IDEA) France, Phase III Trial.

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1
Thierry André and Benoist Chibaudel, Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris; Thierry André, Sorbonne Universités, UMPC Paris 06; Marine Hug de Larauze and Benoist Chibaudel and Thierry André, Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR); Christophe Louvet, Institut Mutualiste Montsouris; Céline Lepère, Hôpital Européen Georges Pompidou (HEGP); Gaël Deplanque, Groupe Hospitalier Saint-Joseph; Jean-Baptiste Bachet, Groupe Hospitalier Pitié Salpêtrière and Sorbonne Université, UMPC Paris 06; Ahmed Khalil, Hôpital Tenon; Julien Taieb, Hôpital Européen Georges Pompidou and Sorbonne Paris Cité, Université Paris Descartes, Paris; Julien Taieb, Fédération Française de Cancérologie Digestive; Jeremie Bez, Fédération Française de Cancérologie Digestive; François Ghiringhelli, Centre Georges-François Leclerc, Dijon; Dewi Vernerey and Sophie Paget-Bailly, CHU de Besançon; Serge Fratte, Hôpital de Besançon; Sophie Paget-Bailly, Franck Bonnetain and Dewi Vernerey INSERM UMR1098, Besançon; Laurent Mineur, Institut Sainte Catherine, Avignon; Jaafar Bennouna, Institut de Cancérologie de l'Ouest René Gauducheau, Saint-Herblain et Institut de Cancérologie Paul Papin, Angers; Jérôme Desrame, Hôpital Jean Mermoz, Lyon; Roger Faroux, Centre Hospitalier Départemental de La Roche sur Yon, La Roche sur Yon; Serge Fratte, Hôpital of Belfort-Montbeliard, Montbeliard; Jérôme Dauba, Centre Hospitalier Layné, Mont-de-Marsan; Olivier Dupuis, Clinique Victor Hugo, Le Mans; Yves Becouran, Institut Bergonié, Bordeaux; May Mabro, Hôpital Foch, Suresnes; Joëlle Egreteau, Centre Hospitalier de Bretagne Sud Site de Lorient, Lorient; Olivier Bouche, Hôpital Robert Debré, Reims; Marc Ychou, Institut du Cancer de Montpellier, and CHU de Montpellier, Montpellier; Marie Pierre Galais, Centre Francois Baclesse, Caen; Louis Marie Dourthe, Clinique Sainte Anne, Strasbourg; and Aimery de Gramont, Institut Hospitalier Franco-Britannique, Levallois-Perret, France.

Abstract

Purpose Reduction of adjuvant treatment duration may decrease toxicities without loss of efficacy in stage III colon cancer. This could offer clear advantages to patients and health care providers. Methods In International Duration Evaluation of Adjuvant Chemotherapy (IDEA) France, as part of the IDEA international collaboration, patient with colon cancer patients were randomly assigned to 3 and 6 months of modified FOLFOX6 (mFOLFOX6: infusional fluorouracil, leucovorin, and oxaliplatin) or capecitabine plus oxaliplatin (CAPOX) by physician choice. The primary end point was disease-free survival (DFS), and analyses were descriptive. Results A total of 2,010 eligible patients received either 3 or 6 months of chemotherapy (modified intention-to-treat population); 2,000 (99%) had stage III colon cancer (N1: 75%, N2: 25%); 1,809 (90%) received mFOLFOX6, and 201 (10%) received CAPOX. The median age was 64 years, and the median follow-up time was 4.3 years. Overall, 94% (3 months) and 78% (6 months) of patients completed treatment (fluoropyrimidines ± oxaliplatin). Maximal grade 2 and 3 neuropathy rates were 28% and 8% in the 3-month arm and 41% and 25% in the 6-month arm ( P < .001). Final rates of residual neuropathy greater than grade 1 were 3% in the 3-month arm and 7% in the 6-month arm ( P < .001). There were 578 DFS events: 314 and 264 in the 3- and 6-month arms, respectively. The 3-year DFS rates were 72% and 76% in the 3- and 6-month arms, respectively (hazard ratio [HR], 1.24; 95% CI, 1.05 to 1.46; P = .0112). In the 3 and 6-month arms, respectively, for patients who received mFOLFOX6, the 3-year DFS rates were 72% and 76% (HR, 1.27; 95% CI, 1.07 to 1.51); for the T4 and/or N2 population, they were 58% and 66% (HR, 1.44; 95% CI, 1.14 to 1.82); and for the T1-3N1 population, they were 81% and 83% (HR, 1.15; 95% CI, 0.89 to 1.49). Conclusion IDEA France, in which 90% of patients received mFOLFOX6, shows superiority of 6 months of adjuvant chemotherapy compared with 3 months, especially in the T4 and/or N2 subgroups. These results should be considered alongside the international IDEA collaboration data.

PMID:
29620995
DOI:
10.1200/JCO.2017.76.0355

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