The prospective French participitation to IDEA (International Duration Evaluation of Adjuvant Chemotherapy) study in stage III colon cancer: Patients’ characteristics and safety analysis of 3 versus 6 months of adjuvant chemotherapy.

Authors

Thierry Andre

Thierry Andre

Hôpital Saint-Antoine, Paris, France

Thierry Andre , Aimery De Gramont , Laurent Mineur , Jérôme Desramé , Roger Faroux , Jaafar Bennouna , Jérôme Dauba , Christophe Louvet , Simon Pernot , Yves Becouarn , May Mabro , Joëlle Egreteau , Olivier Bouche Sr., Franck Bonnetain , Marine Hug de Larauze , Karine Le Malicot , Julien Taieb , Olivier Jean Marie Dupuis

Organizations

Hôpital Saint-Antoine, Paris, France, Institut Hospitalier Franco-Britannique, Levallois-Perret, France, Institut Sainte-Catherine, Avignon, France, Hôpital Privé Jean Mermoz, Lyon, France, Centre Hospitalier Départemental Les Oudairies, La Roche sur Yon, France, Institut de Cancérologie de l'Ouest, Nantes, France, Centre Hospitalier Layné, Mont De Marsan, France, Institut Mutualiste Montsouris, Paris, France, Hôpital Européen Georges-Pompidou, Paris, France, Institut Bergonié, Bordeaux, France, Hôpital Foch, Suresnes, France, Centre Hospitalier Bretagne Sud, Lorient, France, Centre Hospitalier Universitaire Robert Debré, Reims, France, Centre Hospitalier Régional et Universitaire, Besançon, France, GERCOR, Paris, France, FFCD, Dijon, France, Clinique Victor Hugo, Le Mans, France

Research Funding

Other

Background: The IDEA international collaboration was established to prospectively combine/analyze data from six randomized trials to assess whether a 3-month course of oxaliplatin/fluoropyrimidines-based adjuvant chemotherapy (CT) is non-inferior to the 6-month current standard treatment in stage III colon cancer (CC). The primary endpoint of IDEA was 3-year disease-free survival. The accrual goal for the French IDEA study was 2,000 patients. Methods: French IDEA randomized patients with stage III CC between 3 months (arm A) and 6 months (arm B) of adjuvant CT with modified (m) FOLFOX6 or XELOX (depending on physician/patient choice). Oxaliplatin was stopped in case of persistent neuropathy grade ≥2 with fluoropyrimidines continuation for the planned duration. Toxicity was graded during treatment and follow-up using NCI-CTCAE v3.0. Results: From May 2009 to May 2014, 2,023 patients were randomized in 129 French centers either to arm A (n=1009, 49.9%) or to arm B (n=1014, 50.1%). 2012 (99.5%) patients had stage III disease (N1: 75%; N2: 25%) and 11 patients had stage II (n=2) or stage IV disease (n=9). Median age was 64 years (18-85). 89.4% of patients received mFOLFOX6, 10.1% of patients received XELOX, and 0.5% of patients did not receive any study treatment. Overall, 94.1% and 77.5% of patients completed 3 months (arm A) and 6 months (arm B) of CT, respectively. Median oxaliplatin dose was 500 mg/m2 in arm A and 747 mg/m2in arm B. Toxicity profiles depended on the FU backbone with more grade 3/4 neutropenia on mFOLFOX6 (15.0% vs 6.5%) and more grade 3/4 diarrhea (4.7% vs 8.1%) on XELOX. Grade 2/3-4 peripheral neuropathy was less common in arm A than in arm B (23.2/6% vs 37.9/20.4%). Grade 2/3-4 residual neuropathy for patients with a follow-up of at least 3 years (n=811, median follow-up of 3.91 years) was 2.3/0.5% in arm A vs 3.9/ 2.4% in arm B. At 6 months after randomization, mortality rate was 0.7% (n=7) on arm A and 0.5% (n=5) on arm B. Median follow-up is 2.74 years for the whole population. Conclusions: Both mFOLFOX6 and XELOX were safe. Peripheral neuropathy was lower in arm A than in arm B. Clinical trial information: 2009-010384-16.

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Abstract Details

Meeting

2016 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Cancers of the Colon, Rectum, and Anus

Track

Cancers of the Colon, Rectum, and Anus

Sub Track

Multidisciplinary Treatment

Clinical Trial Registration Number

2009-010384-16

Citation

J Clin Oncol 34, 2016 (suppl 4S; abstr 633)

DOI

10.1200/jco.2016.34.4_suppl.633

Abstract #

633

Poster Bd #

G16

Abstract Disclosures