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When clinical practice demands to go beyond statistics: Adjuvant chemotherapy of colon cancer. The 3 vs 6 month story

1584 - Three versus six months adjuvant oxaliplatin-based chemotherapy for patients with stage III colon cancer: per-protocol, subgroups and long-lasting neuropathy results.

Date

11 Sep 2017

Session

When clinical practice demands to go beyond statistics: Adjuvant chemotherapy of colon cancer. The 3 vs 6 month story

Presenters

Julien Taieb

Citation

Annals of Oncology (2017) 28 (suppl_5): v158-v208. 10.1093/annonc/mdx393

Authors

J. Taieb1, F. Bonnetain2, L. Mineur3, J. Bennouna4, J. Desrame5, R. Faroux6, S. Fratte7, J. Dauba8, D. Vernerey2, C. Louvet9, C. Lepere10, O. Dupuis11, Y. Becouarn12, M. Mabro13, J. Egreteau14, O. Bouche15, G. Deplanque16, M. Ychou17, A. de Gramont18, T. André19

Author affiliations

  • 1 Department Of Gastroenterology And Digestive Oncology, Hôpital Européen Georges Pompidou, 75015 - Paris/FR
  • 2 Methodological And Quality Of Life Unit In Oncology (inserm Umr 1098), University Hospital Jean Minjoz, 25000 - Besançon/FR
  • 3 Radiotherapy And Oncology Gi And Liver, Institut Ste Catherine, Avignon/FR
  • 4 Digestive Oncology, CHU de Nantes, 44093 - Nantes/FR
  • 5 Hepato-gastroenterology, Hôpital privé Jean Mermoz, 69373 - Lyon/FR
  • 6 Hepato-gastroenterology, CHD Vendee - Hopital Les Oudairies, 85925 - La Roche sur Yon/FR
  • 7 Hepato-gastroenterology, CH Belfort Monbéliard, CHU de Besançon and Institut de Cancérologie de Franche-Comté, 90000 - Belfort and Besançon/FR
  • 8 Medical Oncology, Centre hospitalier de Mont-de-Marsan (site Layné), 40024 - Mont de Marsan/FR
  • 9 Medical Oncology, Institut Mutualiste Montsouris, 75014 - Paris/FR
  • 10 Department Of Gastroenterology, European Georges Pompidou Hospital, 75015 - Paris/FR
  • 11 Medical Oncology, Clinique Victor Hugo, 72000 - Le Mans/FR
  • 12 Hepato-gastroenterology, Institut Bergonié, 33076 - Bordeaux/FR
  • 13 Medical Oncology, Hopital Foch, 92151 - Suresnes/FR
  • 14 Medical Oncology, Centre Hospitalier Bretagne Sud, 56100 - Lorient/FR
  • 15 Hepato-gastroenterology, CHU Robert Debré, 51092 - Reims/FR
  • 16 Medical Oncology, Hopital Riviera Chablais, 1800 - Vevey/CH
  • 17 Medical Oncology  , ICM Val d'Aurelle, 34298 - Montpellier/FR
  • 18 Medical Oncology, Institut Hospitalier Franco-Britannique, 92300 - Levallois-Perret/FR
  • 19 Medical Oncology, Hopital Saint Antoine, 75571 - Paris/FR
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Abstract 1584

Background

The International Duration Evaluation of Adjuvant chemotherapy (IDEA) collaboration was established to combine data from 6 randomized trials to assess whether 3-month (3M) of oxaliplatin/fluoropyrimidines-based adjuvant chemotherapy is non-inferior to 6-month (6M) for 3-year disease-free survival (DFS) in stage III colon cancer (CC).

Methods

IDEA France randomized patients (pts) between 3M and 6M of chemotherapy with mFOLFOX6 or XELOX (physician choice). DFS was estimated using the Kaplan–Meier method and described using a 3-year DFS rate with 95% confidence interval (CI). Cox-proportional-hazard models were performed to estimate the hazard ratios (HRs) and 95% CIs. We present here the results in the modified ITT (mITT: pts receiving at least one dose of treatment) and modified per-protocol (mPP: pts receiving 3M in the 3M arm and >5M in the 6M arm) populations. Subgroups and long lasting neuropathy results are also reported here.

Results

From May 2009 to May 2014, 2022 pts were randomized from 129 centers and 2010 (99%) and 1757 (87%) were included in the mITT and mPP populations, respectively. With a median follow-up of 4.3 years, the 3-year DFS rate was 72% and 76% (HR = 1.24; 95% CI 1.05–1.46, p = 0.01) for the 3M and 6M mITT populations, respectively and 72% and 78% (HR = 1.36; 95% CI 1.14–1.63, p = 0.0008) for the 3M and 6 M mPP populations. In the mITT FOLFOX treated population (90% of pts), 3-year DFS was 81% (3M) and 83% (6M) for T1-3/N1 pts (N = 1106, HR = 1.15 95%CI 0.89-1.49) and 58% (3M) and 66% (6M) for T4/N2 pts (N = 702, HR = 1.44 95%CI 1.14-1.82). Grade >1 neuropathy was observed in 36% and 67% of pts (p 1 neuropathy was 2.8% and 7.4% (p 

Conclusions

The IDEA France study, with 90% of pts treated with mFOLFOX6, shows that 6M adjuvant treatment is superior to 3M. However, this difference was not significant in the mITT and mPP T1-3N1 populations suggesting that 3M of the mFOLFOX6 regimen could be an option for these pts. Clinically relevant (grade>1) neuropathy was significantly higher in the 6M arm, with long-lasting neuropathy in 7.4% of pts.

Clinical trial identification

Registration Number (European Union Drug Regulating Authorities Clinical Trials): 2009-010384-16

Legal entity responsible for the study

GERCOR - Groupe Coopérateur Multidisciplinaire en Oncologie

Funding

French Ministry of Health and French National Cancer Institute (INCa)

Disclosure

J. Taieb: Advisory board or Board of directors: Sanofi, Baxalta, Roche, Merck, Amgen, Lilly, Celgene. F. Bonnetain: Advisory board or Board of directors: Roche, Ipsen, Amgen, Nestle, Novartis; corporate-sponsored research: Novartis, Roche. L. Mineur: Advisory board or Board of directors: Amgen, Sanofi, Bayer, Roche; corporate-sponsored research: Sanofi, Merck, Chugai. J. Bennouna: Advisory board or Board of directors and honorarium: BMS, Roche, Boehringer Ingelheim, AstraZeneca. D. Vernerey: Honorarium: Janssen, Celgene. Advisory board: HallioDx. C. Lepere: Advisory board or Board of directors: Ipsen. O. Bouche: Advisory board or Board of directors: Merck Serono, Roche, Amgen. M. Ychou: Advisory board or Board of directors: Roche, Bayer, Amgen, Lilly. T. André: Advisory board or Board of directors: BMS, Amgen, Roche; corporate-sponsored research: BMS, Roche; honoraria: Baxter, Bayer, Lilly, MSD, Sanofi, Mundipharma, Novartis. All other authors have declared no conflicts of interest.

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