ArticleBreast cancer research and treatment2024
Immunohistochemical assessment of HER2 low breast cancer: interobserver reproducibility and correlation with digital image analysis.
Article in Breast cancer research and treatment, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed, 9 citations in OpenAlex.
- Revisiting HER2-negative breast cancer in the era of HER2-low and HER2-ultralow expression: Assessment of interobserver variability.Breast (Edinburgh, Scotland) · 2026Article
- "HER2-Low" and the Challenge of Repurposing Legacy HER2 IHC Biomarker Assays.Current oncology (Toronto, Ont.) · 2026Article
- Advances in Breast Cancer Research: Immunological, Pathological, and Pharmacological Perspectives for Improving Patient Outcomes.International journal of molecular sciences · 2026Review
- HER2-Low Breast Cancer at the Interface of Pathology and Technology: Toward Precision Management.Biomedicines · 2025Review
- Inter-rater agreement of HER2-low scores between expert breast pathologists and the Visiopharm digital image analysis application (HER2 APP, CE2797).The journal of pathology. Clinical research · 2025Article
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Authors and funding
12 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe recent findings from the DESTINY-Breast04 trial highlighted the clinical importance of distinguishing between HER2 immunohistochemistry (IHC) scores 0 and 1 + in metastatic breast cancer (BC). However, pathologist interpretation of HER2 IHC scoring is subjective, and standardized methodology is needed. We evaluated the consistency of HER2 IHC scoring among pathologists and the accuracy of digital image analysis (DIA) in interpreting HER2 IHC staining in cases of HER2-low BC.
methodsFifty whole-slide biopsies of BC with HER2 IHC staining were evaluated, comprising 25 cases originally reported as IHC score 0 and 25 as 1 +. These slides were digitally scanned. Six pathologists with breast expertise independently reviewed and scored the scanned images, and DIA was applied. Agreement among pathologists and concordance between pathologist scores and DIA results were statistically analyzed using Kendall coefficient of concordance (W) tests.
resultsSubstantial agreement among at least five of the six pathologists was found for 18 of the score 0 cases (72%) and 15 of the score 1 + cases (60%), indicating excellent interobserver agreement (W = 0.828). DIA scores were highly concordant with pathologist scores in 96% of cases (47/49), indicating excellent concordance (W = 0.959).
conclusionAlthough breast subspecialty pathologists were relatively consistent in evaluating BC with HER2 IHC scores of 0 and 1 +, DIA may be a reliable supplementary tool to enhance the standardization and quantification of HER2 IHC assessment, especially in challenging cases where results may be ambiguous (i.e., scores 0-1 +). These findings hold promise for improving the accuracy and consistency of HER2 testing.
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