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Patient-centered simulations to assess the usefulness of the 70-gene signature for adjuvant chemotherapy administration in early-stage breast cancer

  • Emmanuel Caruana
  • Yohann Foucher
  • Philippe Tessier
  • Jean-Sébastien Frenel
  • Jean-Marc Classe
  • Etienne DantanEmail author
Epidemiology
  • 53 Downloads

Abstract

Purpose

From the MINDACT trial, Cardoso et al. did not demonstrate a significant efficacy for adjuvant chemotherapy (CT) for women with early-stage breast cancer presenting high clinical and low genomic risks. Our objective was to assess the usefulness of the 70-gene signature in this population by using an alternative endpoint: the number of Quality-Adjusted Life-Years (QALYs), i.e., a synthetic measure of quantity and quality of life.

Methods

Based on the results of the MINDACT trial, we simulated a randomized clinical trial consisting of 1497 women with early-stage breast cancer presenting high clinical and low genomic risks. The individual preferences for the different health states and corresponding decrements were obtained from the literature.

Results

The gain in terms of 5-year disease-free survival was 2.8% (95% CI from − 0.1 to 5.7%, from 90.4% for women without CT to 93.3% for women with CT). In contrast, due to the associated side effects, CT significantly reduced the number of QALYs by 62 days (95% CI from 55 to 70 days, from 4.13 years for women without CT to 3.96 years for women with CT).

Conclusion

Our results support the conclusions published by Cardoso et al. by providing additional evidence that the 70-gene signature can be used to avoid overtreatment by CT for women with high clinical risk but low genomic risk.

Keywords

70-gene signature Breast cancer Patient-centered outcomes Stratified medicine Adjuvant chemotherapy 

Abbreviations

95% CI

95% confidence interval

ABC

Adjuvant breast cancer trial

CMF

Cyclophosphamide, methotrexate, and fluorouracil

CT

Chemotherapy

DFS

Disease-free survival

DMFS

Distant metastasis-free survival

EBC

Early-stage breast cancer

E-CMF

Epirubicin followed by cyclophosphamide, methotrexate, fluorouracil

EORTC

European organisation for research and treatment of cancer

FEC60

Fluorouracil, epirubicin, and cyclophosphamide

FEC-D

FEC60 followed by docetaxel

HRQoL

Health-related quality of life

HR

Hazard ratio

MINDACT

Microarray in node-negative disease may avoid chemotherapy

NEAT

National epirubicin adjuvant trial

QALYs

Quality-adjusted life-years

TACT

Taxotere as adjuvant chemotherapy trial

Notes

Acknowledgements

This work was supported by the Cancer National Institute (INCa, MAP-MARKER, No. 2013-137).

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Research involving human participants and/or animals

This article does not contain any studies with animals performed by any of the authors.

Informed consent

For this type of study formal consent is not required.

Supplementary material

10549_2018_5107_MOESM1_ESM.docx (56 kb)
Supplementary material 1 (DOCX 55 KB)

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.INSERM UMR 1246 -SPHERE, Nantes University, Tours UniversityNantesFrance
  2. 2.Nantes University HospitalNantesFrance
  3. 3.Institut de Cancérologie de l’Ouest, Centre René GauducheauSaint-HerblainFrance

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