HER2DX Genomic Assay in HER2-Positive Early Breast Cancer Treated with Trastuzumab and Pertuzumab: A Correlative Analysis from the PHERGain Phase II Trial.

Autor:	Llombart-Cussac A; Arnau de Vilanova Hospital, Valencia, Spain.; Medica Scientia Innovation Research (MEDSIR)-Oncoclínicas and Co., Jersey City, New Jersey, Sao Paulo, Brazil., Pérez-García J; Medica Scientia Innovation Research (MEDSIR)-Oncoclínicas and Co., Jersey City, New Jersey, Sao Paulo, Brazil.; International Breast Cancer Center (IBCC), Pangaea Oncology, Quiron Group, Barcelona, Spain., Brasó-Maristany F; Reveal Genomics, S.L Barcelona, Barcelona, Spain.; Institut D'Investigacions Biomèdiques August Pi i Sunyer Barcelona, Barcelona, Spain., Paré L; Reveal Genomics, S.L Barcelona, Barcelona, Spain., Villacampa G; Vall d'Hebron Institute of Oncology, Barcelona, Spain., Gion M; Hospital Universitario Ramón y Cajal, Madrid, Spain., Schmid P; Bart Cancer Institute, Queen Mary University of London, London, United Kingdom., Colleoni M; Division of Medical Senology, IEO, European Institute of Oncology, IRCCS, Milan, Italy., Borrego MR; Hospital Universitario Virgen del Rocío, Sevilla, Spain., Galván P; Reveal Genomics, S.L Barcelona, Barcelona, Spain.; Institut D'Investigacions Biomèdiques August Pi i Sunyer Barcelona, Barcelona, Spain., Parker JS; Reveal Genomics, S.L Barcelona, Barcelona, Spain.; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina., Buckingham W; Reveal Genomics, S.L Barcelona, Barcelona, Spain., Perou CM; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina., Villagrasa P; Reveal Genomics, S.L Barcelona, Barcelona, Spain., Guerrero JA; Medica Scientia Innovation Research (MEDSIR)-Oncoclínicas and Co., Jersey City, New Jersey, Sao Paulo, Brazil., Sampayo-Cordero M; Medica Scientia Innovation Research (MEDSIR)-Oncoclínicas and Co., Jersey City, New Jersey, Sao Paulo, Brazil., Mancino M; Medica Scientia Innovation Research (MEDSIR)-Oncoclínicas and Co., Jersey City, New Jersey, Sao Paulo, Brazil., Prat A; Reveal Genomics, S.L Barcelona, Barcelona, Spain.; Institut D'Investigacions Biomèdiques August Pi i Sunyer Barcelona, Barcelona, Spain.; Cancer Institute and Blood Diseases, Hospital Clinic de Barcelona, Barcelona, Spain.; Department of Medicine, University of Barcelona, Barcelona, Spain.; Institute of Oncology (IOB)-Hospital Quirónsalud, Barcelona, Spain., Cortés J; Medica Scientia Innovation Research (MEDSIR)-Oncoclínicas and Co., Jersey City, New Jersey, Sao Paulo, Brazil.; International Breast Cancer Center (IBCC), Pangaea Oncology, Quiron Group, Barcelona, Spain.; Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid, Spain.
Jazyk:	angličtina
Zdroj:	Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2024 Sep 13; Vol. 30 (18), pp. 4123-4130.
DOI:	10.1158/1078-0432.CCR-24-0464
Abstrakt:	Purpose: The purpose of this study was to assess the predictive capability of HER2DX assay following (neo)adjuvant trastuzumab-pertuzumab (HP)-based therapy in HER2-positive (HER2+) early breast cancer. Experimental Design: HER2DX was analyzed in baseline pretreatment tumors from the PHERGain trial. Patients with stage I-IIIA HER2+ early breast cancer were randomized to group A [docetaxel, carboplatin, and HP (TCHP)] and group B (HP ± endocrine therapy). PET response was evaluated after two cycles. Group A received TCHP for six cycles regardless of PET response. Group B continued with HP ± endocrine therapy for six cycles (PET responders) or with TCHP for six cycles (PET nonresponders). The primary objective of this retrospective study was to associate the HER2DX pathologic complete response (pCR) score with pCR. The secondary objective was the association of the HER2DX risk score with 3-year invasive disease-free survival (iDFS). Results: HER2DX was performed on 292 (82.0%) tumors. The overall pCR rate was 38.0%, with pCR rates of 56.4% in group A and 33.8% in group B. In multivariable analysis including treatment and clinicopathologic factors, the HER2DX pCR score (continuous variable) significantly correlated with pCR [OR, 1.29; 95% confidence interval (CI), 1.10-1.54; P < 0.001]. HER2DX-defined pCR-high, -med, and -low groups exhibited pCR rates of 50.4%, 35.8%, and 23.2%, respectively (pCR-high vs. pCR-low OR, 3.27; 95% CI, 1.54-7.09; P < 0.001). In patients with residual disease, the HER2DX high-risk group demonstrated numerically worse 3-year iDFS than the low-risk group (89.8% vs. 100%; HR, 2.70; 95% CI, 0.60-12.18; P = 0.197). Conclusions: HER2DX predicts pCR in the context of neoadjuvant HP-based therapy, regardless of chemotherapy addition, and might identify patients at higher risk of recurrence among patients with residual disease. (©2024 The Authors; Published by the American Association for Cancer Research.)
Databáze:	MEDLINE
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