ArticleBMC cancer2009
Inter-observer reproducibility of HER2 immunohistochemical assessment and concordance with fluorescent in situ hybridization (FISH): pathologist assessment compared to quantitative image analysis.
Article in BMC cancer, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 1 of them a synthesis that pooled it.
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Who cites it
39 citing papers in PubMed, 1 synthesis or guideline pooled it, 85 citations in OpenAlex.
- Quantitative Image Analysis of Human Epidermal Growth Factor Receptor 2 Immunohistochemistry for Breast Cancer: Guideline From the College of American Pathologists.Archives of pathology & laboratory medicine · 2019Guideline
- Intra-slide calibration technology improves immunohistochemical harmonization within and between anatomic pathology laboratories.bioRxiv : the preprint server for biology · 2026Article
- Low E-cadherin expression is associated with poor prognosis in pulmonal adenocarcinoma.Scientific reports · 2026Article
- Reliability of stromal markers multiplex immunofluorescent staining: pathologist assessment compared to quantitative image analysis.American journal of cancer research · 2026Article
- Article
- Associations of stem cell markers CD44, CD24 and ALDH1A1 with mammographic breast density in women with benign breast biopsies.British journal of cancer · 2024Article
- Clinical application of the HM-1000 image processing for HER2 fluorescence in situ hybridization signal quantification in breast cancer.Diagnostic pathology · 2024Article
- Comprehensive Assessment of Immune Phenotype and Its Effects on Survival Outcomes in HER2-Low versus HER2-Zero Breast Cancer.Breast cancer (Dove Medical Press) · 2024Article
- Reproductive factors and expression of stem cell markers in women with incident benign breast disease.American journal of cancer research · 2024Article
- Enhancing the anticancer potential of metformin: fabrication of efficient nanospanlastics,International journal of pharmaceutics: X · 2023Article
- Diagnostic Role and Prognostic Impact of PSAP Immunohistochemistry: A Tissue Microarray Study on 31,358 Cancer Tissues.Diagnostics (Basel, Switzerland) · 2023Article
- Deep learning to automatically evaluate HER2 gene amplification status from fluorescence in situ hybridization images.Scientific reports · 2023Article
- Determining HER2 Status by Artificial Intelligence: An Investigation of Primary, Metastatic, and HER2 Low Breast Tumors.Diagnostics (Basel, Switzerland) · 2023Article
- HER2-low breast cancer shows a lower immune response compared to HER2-negative cases.Scientific reports · 2022Article
- Digital validation of breast biomarkers (ER, PR, AR, and HER2) in cytology specimens using three different scanners.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2022Article
- Reliability of CD44, CD24, and ALDH1A1 immunohistochemical staining: Pathologist assessment compared to quantitative image analysis.Frontiers in medicine · 2022Article
- Her2-Positive Cancers and Antibody-Based Treatment: State of the Art and Future Developments.Cancers · 2021Review
- Reimagining T Staging Through Artificial Intelligence and Machine Learning Image Processing Approaches in Digital Pathology.JCO clinical cancer informatics · 2020Article
- Age-correlated protein and transcript expression in breast cancer and normal breast tissues is dominated by host endocrine effects.Nature cancer · 2020Article
- Insulin-like growth factor-1 receptor expression in upper tract urothelial carcinoma.Virchows Archiv : an international journal of pathology · 2019Article
Corrections and comments
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Authors and funding
9 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn breast cancer patients, HER2 overexpression is routinely assessed by immunohistochemistry (IHC) and equivocal cases are subject to fluorescent in situ hybridization (FISH). Our study compares HER2 scoring by histopathologists with automated quantitation of staining, and determines the concordance of IHC scores with FISH results.
methodsA tissue microarray was constructed from 1,212 invasive breast carcinoma cases with linked treatment and outcome information. IHC slides were semi-quantitatively scored by two independent pathologists on a range of 0 to 3+, and also analyzed with an Ariol automated system by two operators. 616 cases were scorable by both IHC and FISH.
resultsUsing data from unequivocal positive (3+) or negative (0, 1+) results, both visual and automated scores were highly consistent: there was excellent concordance between two pathologists (kappa = 1.000, 95% CI: 1-1), between two machines (kappa = 1.000, 95% CI: 1-1), and between both visual and both machine scores (kappa = 0.898, 95% CI: 0.775-0.979). Two pathologists successfully distinguished negative, positive and equivocal cases (kappa = 0.929, 95% CI: 0.909-0.946), with excellent agreement with machine 1 scores (kappa = 0.835, 95% CI: 0.806-0.862; kappa = 0.837, 95% CI: 0.81-0.862), and good agreement with machine 2 scores (kappa = 0.698, 95% CI: 0.6723-0.723; kappa = 0.709, 95% CI: 0.684-0.732), whereas the two machines showed good agreement (kappa = 0.806, 95% CI: 0.785-0.826). When comparing categorized IHC scores and FISH results, the agreement was excellent for visual 1 (kappa = 0.814, 95% CI: 0.768-0.856), good for visual 2 (kappa = 0.763, 95% CI: 0.712-0.81) and machine 1 (kappa = 0.665, 95% CI: 0.609-0.718), and moderate for machine 2 (kappa = 0.535, 95% CI: 0.485-0.584).
conclusionA fully automated image analysis system run by an experienced operator can provide results consistent with visual HER2 scoring. Further development of such systems will likely improve the accuracy of detection and categorization of membranous staining, making this technique suitable for use in quality assurance programs and eventually in clinical practice.
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