Patient-Centered Simulations to Assess the Usefulness of the 70-Gene Signature for Adjuvant Chemotherapy Administration in Early-Stage Breast Cancer

Emmanuel Caruana (1, 2, 3) , Yohann Foucher (1, 2, 3, 4) , Philippe Tessier (1, 2, 3) , Jean-Sébastien Frenel (5, 6) , Jean-Marc Classe (5, 6) , Etienne Dantan (1, 2, 3)

1 SPHERE - MethodS in Patients-centered outcomes and HEalth ResEarch
2 UN - Université de Nantes
3 UT - Université de Tours
4 CHU Nantes - Centre Hospitalier Universitaire de Nantes
5 UNICANCER/ICO - Institut de Cancérologie de l'Ouest [Angers/Nantes]
6 CRLCC René Gauducheau

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.

Mots clés: Stratified medicine; Randomized Controlled Trials as Topic; Quality-Adjusted Life Years; Quality of Life; Patient-centered outcomes; Neoplasm Staging; Humans; Gene Regulatory Networks; Female; Disease-Free Survival; Computer Simulation; Adjuvant; Chemotherapy; Breast Neoplasms; Breast cancer; Immunologic; Adjuvants; Adjuvant chemotherapy; 70-gene signature

Domaines: Sciences du Vivant [q-bio]

Emmanuel Caruana, Yohann Foucher, Philippe Tessier, Jean-Sébastien Frenel, Jean-Marc Classe, et al.. Patient-Centered Simulations to Assess the Usefulness of the 70-Gene Signature for Adjuvant Chemotherapy Administration in Early-Stage Breast Cancer. Breast Cancer Research and Treatment, 2019, 174 (2), pp.537-542. ⟨10.1007/s10549-018-05107-6⟩. ⟨hal-03158776⟩