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

Autores da FMUP
Participantes de fora da FMUP
- Viale, G
- Basik, M
- Niikura, N
- Tokunaga, E
- Brucker, S
- Penault-Llorca, F
- Hayashi, N
- Sohn, J
- Sousa, RTD
- Brufsky, AM
- O'Brien, CS
- Higgins, G
- Varghese, D
- James, GD
- Moh, A
- Livingston, A
- de Giorgio-Miller, V
Unidades de investigação
Abstract
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%; K = 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.
Dados da publicação
- ISSN/ISSNe:
- 2059-7029, 2059-7029
- Tipo:
- Article
- Páginas:
- -
- PubMed:
- 37562195
- Link para outro recurso:
- www.scopus.com
ESMO Open Elsevier BV
Citações Recebidas na Web of Science: 7
Citações Recebidas na Scopus: 21
Documentos
- Não há documentos
Filiações
Keywords
- breast cancer; human epidermal growth factor receptor 2; HER2-low; immunohistochemistry; prevalence; retrospective study
Financiamento
Projetos associados
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Investigador Principal: Fernando Carlos de Landér Schmitt
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