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

3783 - Prospective pooled analysis of six phase III trials investigating duration of adjuvant (adjuv) oxaliplatin-based therapy (3 vs 6 months) for patients (pts) with stage III colon cancer (CC): Updated results of IDEA (International Duration Evaluation of Adjuvant chemotherapy)

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

Axel Grothey

Citation

Annals of Oncology (2017) 28 (suppl_5): v605-v649. 10.1093/annonc/mdx440

Authors

A. Grothey1, A. Sobrero2, J.A. Meyerhardt3, T. Yoshino4, J. Paul5, J. Taieb6, I. Souglakos7, R. Kerr8, R. Labianca9, A.F. Shields10, F. Bonnetain11, T. Yamanaka12, I. Boukovinas13, Q. Shi14, J.P. Meyers14, D. Niedzwiecki15, V. Torri16, D.J. Sargent14, T. André17, T. Iveson18

Author affiliations

  • 1 Division Of Medical Oncology, Mayo Clinic, 55905 - Rochester/US
  • 2 Medical Oncology Unit, IRCCS San Martino, 16132 - Genova/IT
  • 3 Medical Oncology, Dana-Farber Cancer Institute, 2215 - Boston/US
  • 4 Department Of Gastroenterology And Gastrointestinal Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 5 Cancer Research Uk Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow/GB
  • 6 Gastroenterology And Digestive Oncology, Hôpital européen Georges-Pompidou , Sorbonne Paris Cité Université Paris Descartes, 75015 - Paris/FR
  • 7 Dept Of Medical Oncology, University Hospital of Heraklion (PAGNI), 710 03 - Heraklion/GR
  • 8 Dept Of Oncology, Churchill Hospital University of Oxford, OX3 7LE - Oxford/GB
  • 9 Dept Of Oncology, Ospedale Papa Giovanni XXIII, 24127 - Bergamo/IT
  • 10 Dept Of Oncology, Karmanos Cancer Institute, 48201-2013 - Detroit/US
  • 11 Methodological And Quality Of Life Unit In Oncology (inserm Umr 1098), University Hospital Jean Minjoz, 25000 - Besançon/FR
  • 12 Medical Course Biostatistics, Yokohama City University School of Medicine, 236-0004 - Yokohama/JP
  • 13 Medical Oncology Unit, Bioclinic Thessaloniki, Thessaloniki/GR
  • 14 Dept Of Biomedical Statistics And Informatics, Mayo Clinic, 55905 - Rochester/US
  • 15 Department Of Biostatistics And Bioinformatics, Duke University,, Durham/US
  • 16 Dept Of Oncology, IRRCS Mario Negri Institute for Pharmacological Research, 20133 - Milan/IT
  • 17 Medical Oncology, Hopital Saint Antoine, 75571 - Paris/FR
  • 18 Dept Of Medical Oncology, University Hospital Southampton, SO16 6YD - Southampton/GB
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Abstract 3783

Background

Since 2004, 6 months (m) of oxaliplatin (oxali)-based treatment has been the standard of care as adjuv therapy for stage III CC. As oxali is associated with cumulative neurotoxicity, a shorter duration of adjuv therapy could spare pts toxicity and lead to substantial saving in health expenditures.

Methods

A prospective, pre-planned pooled analysis of 6 concurrently conducted randomized phase 3 trials (SCOT, TOSCA, Alliance/SWOG 80702, IDEA France, ACHIEVE, HORG) was performed to evaluate the non-inferiority (NI) of 3m compared with 6m (ref) of adj FOLFOX/CAPOX. The primary endpoint was disease-free survival (DFS), defined as time from enrolment to relapse, 2nd CRC, and death (all causes). NI was to be declared if the 2-sided 95% confidence interval (CI) for DFS Hazard Ratio (HR 3m v 6m) estimated by a stratified Cox model was below 1.12. NI was examined within regimen and stage subgroups as pre-planned.

Results

The analysis included 12,834 pts from 12 countries, accrued 6/07-12/15. After 3263 (of 3390 expected) DFS events NI for the shorter duration of therapy could not be confirmed for the overall study population (HR 1.07, 95%CI 1.00-1.15). NI of 3m v 6m was seen for CAPOX (HR 0.95, 95%CI 0.85-1.06; whereas 3m of FOLFOX was inferior to 6m (HR 1.16, 95%CI 1.06-1.26). Pts treated with CAPOX (vs FOLFOX) had a higher rate of T4 CC (24.3% vs 18.6%, p 

Conclusions

The IDEA results provide the basis for individual adjustments of adj treatment duration based on risk of recurrence, pt preference, toxicity and the chemotherapy regimen used. Further analyses are warranted to explain the different performance of CAPOX and FOLFOX with regard to the NI question.

Clinical trial identification

NCT00749450 (SCOT); NCT00646607 (TOSCA); NCT01150045 (CALGB/SWOG 80702); NCT00958737 (IDEA France); NCT01308086 (HORG); UMIN-CTR Clinical Trial Identifier: UMIN000008543 (ACHIEVE)

Legal entity responsible for the study

Mayo Clinic

Funding

Mayo Clinic, U10CA180821, U10CA180835, U10CA180882, U10CA180888, U10CA180835, INCA, PHRC2009, EME 09/800/34, HTA 14/140/84, CRUK C1348/A15960, JFMC

Disclosure

All authors have declared no conflicts of interest.

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