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Retrospective study to estimate the prevalence and describe the clinicopathological characteristics, treatments received, and outcomes of HER2-low breast cancer

 G Viale  ;  M Basik  ;  N Niikura  ;  E Tokunaga  ;  S Brucker  ;  F Penault-Llorca  ;  N Hayashi  ;  J Sohn  ;  R Teixeira de Sousa  ;  A M Brufsky  ;  C S O'Brien  ;  F Schmitt  ;  G Higgins  ;  D Varghese  ;  G D James  ;  A Moh  ;  A Livingston  ;  V de Giorgio-Miller 
 ESMO OPEN, Vol.8(4) : 101615, 2023-08 
Journal Title
Issue Date
Biomarkers, Tumor* ; Breast Neoplasms* / diagnosis ; Breast Neoplasms* / epidemiology ; Breast Neoplasms* / therapy ; Female ; Humans ; In Situ Hybridization ; Prevalence ; Receptor, ErbB-2 / genetics ; Retrospective Studies
HER2-low ; breast cancer ; human epidermal growth factor receptor 2 ; immunohistochemistry ; prevalence ; retrospective study.
Background: Approximately 80% of all breast cancers (BCs) are currently categorized as human epidermal growth factor receptor 2 (HER2)-negative [immunohistochemistry (IHC) 0, 1+, or 2+/in situ hybridization (ISH) negative]; approximately 60% of BCs traditionally categorized as HER2-negative express low levels of HER2. HER2-low (IHC 1+ or IHC 2+/ISH−) status became clinically actionable with approval of trastuzumab deruxtecan to treat unresectable/metastatic HER2-low BC. Greater understanding of patients with HER2-low disease is urgently needed. Patients and methods: This global, multicenter, retrospective study (NCT04807595) included tissue samples from patients with confirmed HER2-negative unresectable/metastatic BC [any hormone receptor (HR) status] diagnosed from 2014 to 2017. Pathologists rescored HER2 IHC-stained slides as HER2-low (IHC 1+ or IHC 2+/ISH−) or HER2 IHC 0 after training on low-end expression scoring using Ventana 4B5 and other assays at local laboratories (13 sites; 10 countries) blinded to historical scores. HER2-low prevalence and concordance between historical scores and rescores were assessed. Demographics, clinicopathological characteristics, treatments, and outcomes were examined. Results: In rescored samples from 789 patients with HER2-negative unresectable/metastatic BC, the overall HER2-low prevalence was 67.2% (HR positive, 71.1%; HR negative, 52.8%). Concordance was moderate between historical and rescored HER2 statuses (81.3%; κ = 0.583); positive agreement was numerically higher for HER2-low (87.5%) than HER2 IHC 0 (69.9%). More than 30% of historical IHC 0 cases were rescored as HER2-low overall (all assays) and using Ventana 4B5. There were no notable differences between HER2-low and HER2 IHC 0 in patient characteristics, treatments received, or clinical outcomes. Conclusions: Approximately two-thirds of patients with historically HER2-negative unresectable/metastatic BC may benefit from HER2-low-directed treatments. Our data suggest that HER2 reassessment in patients with historical IHC 0 scores may be considered to help optimize selection of patients for treatment. Further, accurate identification of patients with HER2-low BC may be achieved with standardized pathologist training. © 2023 The Author(s)
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Sohn, Joo Hyuk(손주혁) ORCID logo https://orcid.org/0000-0002-2303-2764
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