Portal de investigação
Retrospective study to estimate the prevalence and describe the clinicopathological characteristics, treatments received, and outcomes of HER2-low breast cancer
Data de publicação:
Data Ahead of Print:
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:
- -
- 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
Proyectos asociados
Parâmetros que demonstram ter influência na resposta à terapia neoadjuvante em pacientes com cancro da mama: Estado da arte e perspetivas futuras
Investigador Principal: Fernando Carlos de Landér Schmitt
Estudo Clínico Académico . 2021
Citar a publicação
Viale G,Basik M,Niikura N,Tokunaga E,Brucker S,Penault F,Hayashi N,Sohn J,Sousa RTD,Brufsky AM,O'Brien CS,Schmitt F,Higgins G,Varghese D,James GD,Moh A,Livingston A,de Giorgio V. Retrospective study to estimate the prevalence and describe the clinicopathological characteristics, treatments received, and outcomes of HER2-low breast cancer. ESMO Open. 2023. 8. (4):101615. IF:7,300. (1).
