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.

Autor:	Penault-Llorca F; Centre de Lutte Contre le Cancer Jean Perrin, Imagerie Moléculaire et Stratégies Théranostiques, Université Clermont Auvergne, UMR 1240 INSERM-UCA, Clermont Ferrand. Electronic address: Frederique.PENAULT-LLORCA@clermont.unicancer.fr., Dalenc F; Oncopole Claudius Regaud, IUCT, Toulouse., Chabaud S; Centre Léon Bérard, Lyon., Cottu P; Institut Curie, Paris., Allouache D; Centre François Baclesse, Caen, France., Cameron D; Western General Hospital, Edinburg, UK., Grenier J; Institut Sainte Catherine, Avignon., Venat Bouvet L; CHU Dupuytren, Limoges, France., Jegannathen A; Royal Stoke Hospital, Stoke-on-Trent, UK., Campone M; Institut de cancérologie de l'Ouest, Saint-Herblain & Angers., Debled M; Institut Bergonié, Bordeaux., Hardy-Bessard AC; Centre CARIO-HPCA, Plérin., Giacchetti S; APHP Hôpital Saint Louis, Paris., Barthelemy P; Institut de Cancérologie Strasbourg Europe, Strasbourg., Kaluzinski L; Centre Hospitalier Cotentin, Cherbourg en Cotentin., Mailliez A; Centre Oscar Lambret, Lille., Mouret-Reynier MA; Centre de Lutte Contre le Cancer Jean Perrin, Imagerie Moléculaire et Stratégies Théranostiques, Université Clermont Auvergne, UMR 1240 INSERM-UCA, Clermont Ferrand., Legouffe E; Centre Oncogard, Nîmes., Cayre A; Centre de Lutte Contre le Cancer Jean Perrin, Imagerie Moléculaire et Stratégies Théranostiques, Université Clermont Auvergne, UMR 1240 INSERM-UCA, Clermont Ferrand., Martinez M; Clinique Pasteur, Toulouse., Delbaldo C; Hôpital Diaconesses, Paris., Mollon-Grange D; Hôpital Laennec, Quimper, France., Macaskill EJ; Ninewells Hospital, Dundee., Sephton M; Musgrove Park Hospital, Taunton, UK., Stefani L; Centre Hospitalier Annecy, Pringy., Belgadi B; Centre Hospitalier Montélimar, Montélimar, France., Winter M; Weston Park Hospital, Sheffield, UK., Orfeuvre H; Centre Hospitalier Fleyriat, Bourg-en-Bresse., Lacroix-Triki M; Gustave Roussy, Villejuif, France., Bonnefoi H; Institut Bergonié, Bordeaux., Bliss J; The Institute of Cancer Research, London, UK., Canon JL; Grand Hôpital de Charleroi, Charleroi, Belgium., Lemonnier J; UNICANCER, Paris, France., Andre F; Gustave Roussy, Villejuif, France., Bachelot T; Centre Léon Bérard, Lyon.
Jazyk:	angličtina
Zdroj:	ESMO open [ESMO Open] 2024 May; Vol. 9 (5), pp. 103443. Date of Electronic Publication: 2024 Apr 30.
DOI:	10.1016/j.esmoop.2024.103443
Abstrakt:	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. Competing Interests: Disclosure FPL: advisor for AstraZeneca, Daiichi Sankyo, Genomic Health, GILEAD, GSK, Lilly, Menarini/Stemline, MSD, Myriad, Nanostring, Novartis, Pfizer, Pierre-Fabre, Roche; funding: MSD, Myriad, AstraZeneca, Daiichi Sankyo; travel/expenses: AstraZeneca, BMS, Daiichi Sankyo, MSD, Novartis, Pfizer. FD: advisor for Daichi, Seagen, Novartis, Gilead, Lilly, MSD; travel/expenses: Daichi, Novartis, Pfizer. PC: advisor for Pfizer, Lilly; travel/expenses: Roche, Pfizer, Lilly, Novartis, Sanofi, BMS. JG: advisor for Daiichi Sankyo, Gilead, Pfizer; travel/expenses: Eisai Europe. MC: advisor for Novartis, Sandoz, Accord, Sanofi, Lilly, AstraZeneca, AbbVie, Seattle Genetics, Daiichi Sankyo; consulting fees: Pierre Fabre, Sanofi, Novartis, Servier, Daiichi Sankyo; travel//expenses: Novartis, AstraZeneca, Pfizer, Roche. ACHB: advisor for Novartis, AstraZeneca, Pfizer, Novartis, Clovis Onco, Seattle Genetics, Eisai, Daiichi Sankyo/Astra Zeneca, MSD. SG: advisor for Eisai, Lilly; funding: Merck, AstraZeneca; travel/expenses: Lilly. PB: advisor for Ipsen, BMS, MSD, Pfizer, Merck KGaA, Astellas, Novartis, Gilead, Bayer; travel/expenses: BMS, Pfizer, Janssen-Cilag, Astellas, MSD, Ipsen, Merck. AM: advisor for Pfizer; travel/expenses: AstraZeneca, Pierre Fabre, Lilly. MS: travel/expenses: Eisai Europe. MLT: consulting fees: Myriad Genetics. JB: funding: AstraZeneca, Merck Sharp & Dohme, Puma Biotech, Pfizer, Roche, Lilly, Janssen-Cilag, Clovis Onco; travel/expenses: Pfizer. FA: stock and other ownership interests: PEGASCY; funding: AstraZeneca, Novartis, Pfizer, Lilly, Roche, Daiichi; travel/expenses: Novartis, Roche, GlaxoSmithKline, AstraZeneca. TB: advisor for Roche, Novartis, AstraZeneca, Pfizer, Seattle Genetics, MSD; funding: Roche, Novartis, AstraZeneca, Seattle Genetics, Pfizer; travel/expenses: Roche, Pfizer, AstraZeneca. All other authors have declared no conflicts of interest. (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Databáze:	MEDLINE
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