Prognostic value of EndoPredict test in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative primary breast cancer screened for the randomized, double-blind, phase III UNIRAD trial

TY - JOUR

T1 - Prognostic value of EndoPredict test in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative primary breast cancer screened for the randomized, double-blind, phase III UNIRAD trial

AU - Penault-Llorca, F.

AU - Dalenc, F.

AU - Chabaud, S.

AU - Cottu, P.

AU - Allouache, D.

AU - Cameron, D.

AU - Grenier, J.

AU - Venat Bouvet, L.

AU - Jegannathen, A.

AU - Campone, M.

AU - Debled, M.

AU - Hardy-Bessard, A. C.

AU - Giacchetti, S.

AU - Barthelemy, P.

AU - Kaluzinski, L.

AU - Mailliez, A.

AU - Mouret-Reynier, M.-A.

AU - Legouffe, E.

AU - Cayre, A.

AU - Martinez, M.

AU - Delbaldo, C.

AU - Mollon-Grange, D.

AU - Macaskill, E. J.

AU - Sephton, M.

AU - Stefani, L.

AU - Belgadi, B.

AU - Winter, M.

AU - Orfeuvre, H.

AU - Lacroix-Triki, M.

AU - Bonnefoi, H.

AU - Bliss, J.

AU - Canon, J.-L.

AU - Lemonnier, J.

AU - Andre, F.

AU - Bachelot, T.

N1 - Publisher Copyright: © 2024 The Authors

PY - 2024/5

Y1 - 2024/5

N2 - Background: The purpose of this study was to evaluate the prognostic value of the multigene EndoPredict test in prospectively collected data of patients screened for the randomized, double-blind, phase III UNIRAD trial, which evaluated the addition of everolimus to adjuvant endocrine therapy in high-risk, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. Patients and methods: Patients were classified into low or high risk according to the EPclin score, consisting of a 12-gene molecular score combined with tumor size and nodal status. Association of the EPclin score with disease-free survival (DFS) and distant metastasis-free survival (DMFS) was evaluated using Kaplan–Meier estimates. The independent prognostic added value of EPclin score was tested in a multivariate Cox model after adjusting on tumor characteristics. Results: EndoPredict test results were available for 768 patients: 663 patients classified as EPclin high risk (EPCH) and 105 patients as EPclin low risk (EPCL). Median follow-up was 70 months (range 1-172 months). For the 429 EPCH randomized patients, there was no significant difference in DFS between treatment arms. The 60-month relapse rate for patients in the EPCL and EPCH groups was 0% and 7%, respectively. Hazard ratio (HR) supposing continuous EPclin score was 1.87 [95% confidence interval (CI) 1.4-2.5, P < 0.0001]. This prognostic effect remained significant when assessed in a Cox model adjusting on tumor size, number of positive nodes and tumor grade (HR 1.52, 95% CI 1.09-2.13, P = 0.0141). The 60-month DMFS for patients in the EPCL and EPCH groups was 100% and 94%, respectively (adjusted HR 8.10, 95% CI 1.1-59.1, P < 0.0001). Conclusions: The results confirm the value of EPclin score as an independent prognostic parameter in node-positive, hormone receptor-positive, HER2-negative early breast cancer patients receiving standard adjuvant treatment. EPclin score can be used to identify patients at higher risk of recurrence who may warrant additional systemic treatments.

AB - Background: The purpose of this study was to evaluate the prognostic value of the multigene EndoPredict test in prospectively collected data of patients screened for the randomized, double-blind, phase III UNIRAD trial, which evaluated the addition of everolimus to adjuvant endocrine therapy in high-risk, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. Patients and methods: Patients were classified into low or high risk according to the EPclin score, consisting of a 12-gene molecular score combined with tumor size and nodal status. Association of the EPclin score with disease-free survival (DFS) and distant metastasis-free survival (DMFS) was evaluated using Kaplan–Meier estimates. The independent prognostic added value of EPclin score was tested in a multivariate Cox model after adjusting on tumor characteristics. Results: EndoPredict test results were available for 768 patients: 663 patients classified as EPclin high risk (EPCH) and 105 patients as EPclin low risk (EPCL). Median follow-up was 70 months (range 1-172 months). For the 429 EPCH randomized patients, there was no significant difference in DFS between treatment arms. The 60-month relapse rate for patients in the EPCL and EPCH groups was 0% and 7%, respectively. Hazard ratio (HR) supposing continuous EPclin score was 1.87 [95% confidence interval (CI) 1.4-2.5, P < 0.0001]. This prognostic effect remained significant when assessed in a Cox model adjusting on tumor size, number of positive nodes and tumor grade (HR 1.52, 95% CI 1.09-2.13, P = 0.0141). The 60-month DMFS for patients in the EPCL and EPCH groups was 100% and 94%, respectively (adjusted HR 8.10, 95% CI 1.1-59.1, P < 0.0001). Conclusions: The results confirm the value of EPclin score as an independent prognostic parameter in node-positive, hormone receptor-positive, HER2-negative early breast cancer patients receiving standard adjuvant treatment. EPclin score can be used to identify patients at higher risk of recurrence who may warrant additional systemic treatments.

KW - breast cancer

KW - endocrine therapy

KW - EndoPredict

KW - prognostic biomarker

KW - risk stratification

UR - https://www.scopus.com/pages/publications/85191830168

U2 - 10.1016/j.esmoop.2024.103443

DO - 10.1016/j.esmoop.2024.103443

M3 - Article

C2 - 38692082

AN - SCOPUS:85191830168

SN - 2059-7029

VL - 9

JO - ESMO open

JF - ESMO open

IS - 5

M1 - 103443

ER -