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.
Date
2024-05-01ICR Author
Author
Penault-Llorca, F
Dalenc, F
Chabaud, S
Cottu, P
Allouache, D
Cameron, D
Grenier, J
Venat Bouvet, L
Jegannathen, A
Campone, M
Debled, M
Hardy-Bessard, A-C
Giacchetti, S
Barthelemy, P
Kaluzinski, L
Mailliez, A
Mouret-Reynier, M-A
Legouffe, E
Cayre, A
Martinez, M
Delbaldo, C
Mollon-Grange, D
Macaskill, EJ
Sephton, M
Stefani, L
Belgadi, B
Winter, M
Orfeuvre, H
Lacroix-Triki, M
Bonnefoi, H
Bliss, J
Canon, J-L
Lemonnier, J
Andre, F
Bachelot, T
Type
Journal Article
Metadata
Show full item recordAbstract
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.
Collections
Subject
EndoPredict
breast cancer
endocrine therapy
prognostic biomarker
risk stratification
Humans
Female
Breast Neoplasms
Middle Aged
Prognosis
Receptor, ErbB-2
Double-Blind Method
Aged
Adult
Receptors, Estrogen
Receptors, Progesterone
Everolimus
Disease-Free Survival
Biomarkers, Tumor
Research team
Clin Trials & Stats Unit
Language
eng
Date accepted
2024-04-04
License start date
2024-05-01
Citation
ESMO Open, 2024, 9 (5), pp. 103443 -
Publisher
ELSEVIER
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