ArticleBreast cancer research : BCR2023
High inter-laboratory variability in the assessment of HER2-low breast cancer: a national registry study on 50,714 Danish patients.
Article in Breast cancer research : BCR, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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Who cites it
20 citing papers in PubMed.
- Post Hoc Analysis of the Phase II DESTINY-PanTumor02 Study: Local and Central HER2 IHC Concordance and Trastuzumab Deruxtecan Efficacy by HER2 IHC Status in HER2-Expressing Solid Tumors.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Trial
- HER2-low breast cancer in routine practice: a nationwide study of diagnostic variability across pathology laboratories.Virchows Archiv : an international journal of pathology · 2026Article
- Artificial Intelligence (AI)-Assisted Human Epidermal Growth Factor Receptor 2 (HER2) Scoring in Breast Cancer: Diagnostic Agreement and Understanding Discordance.Laboratory investigation; a journal of technical methods and pathology · 2026Article
- A multigene model for response stratification to neoadjuvant chemotherapy in triple negative breast cancer.Breast (Edinburgh, Scotland) · 2026Article
- Multi-site validation of an AI-based biomarker test for determining ER, PR, and HER2 status from H&E-stained breast cancer slides.ESMO real world data and digital oncology · 2026Article
- Repurposing HER2 IHC: Pan-HER2 and Low-HER2.Applied immunohistochemistry & molecular morphology : AIMM · 2026Review
- Digital image analysis improves diagnostic accuracy of HER2-low and HER2-ultralow breast cancer: a step towards personalised medicine.Virchows Archiv : an international journal of pathology · 2026Article
- Addressing the Challenges in the Identification of HER2-Low and Ultralow Breast Cancer in Asia: A Delphi Consensus.Advances in therapy · 2026Article
- Mechanisms of Resistance and Synergy: The Role of Tumor Microenvironment in HER2-Low Breast Cancer Therapy.Pharmaceuticals (Basel, Switzerland) · 2026Review
- HER2 Heterogeneity in Breast Cancer: Biological Basis, Clinical Implications, and Therapeutic Strategies.Breast cancer (Dove Medical Press) · 2026Review
- Dynamics of HER2 status following neoadjuvant systemic therapy in breast cancer: a large single-center cohort analysis.Therapeutic advances in medical oncology · 2026Article
- New standards in HER2-low testing: the CASI-01 comparative methods study.EBioMedicine · 2025Article
- Report of a national external quality assessment program for HER2-low expression in breast cancer-options for increased accuracy with standardized methodology.Virchows Archiv : an international journal of pathology · 2025Article
- Toward Optimizing the Impact of Digital Pathology and Augmented Intelligence on Issues of Diagnosis, Grading, Staging, and Classification.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2025Review
- Transfer learning drives automatic HER2 scoring on HE-stained WSIs for breast cancer: a multi-cohort study.Breast cancer research : BCR · 2025Article
- HER2-Low Breast Cancer-Current Knowledge and Future Directions.Medicina (Kaunas, Lithuania) · 2025Review
- Recent advances and updated highlights in breast cancer pathologic diagnosis: a narrative review.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2025Review
- Cost-Effectiveness of Trastuzumab Deruxtecan in Patients with Unresectable or Metastatic HER2-Low Breast Cancer Who Have Received Prior Chemotherapy.Advances in therapy · 2025Article
- Survival outcomes for HER2-low breast cancer: Danish national data.Acta oncologica (Stockholm, Sweden) · 2024Article
- Analysis of HER2-Low Breast Cancer in Aotearoa New Zealand: A Nationwide Retrospective Cohort Study.Cancers · 2024Article
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundConsidering the recent advancements in the treatment of breast cancer with low expression of human epidermal growth factor receptor 2 (HER2), we aimed to examine inter-laboratory variability in the assessment of HER2-low breast cancer across all Danish pathology departments.
methodsFrom the Danish Breast Cancer Group, we obtained data on all women diagnosed with primary invasive breast cancer in 2007-2019 who were subsequently assigned for curatively intended treatment.
resultsOf 50,714 patients, HER2 score and status were recorded for 48,382, among whom 59.2% belonged to the HER2-low group (score 1+ or 2+ without gene amplification), 26.8% had a HER2 score of 0, and 14.0% were HER2 positive. The proportion of HER2-low cases ranged from 46.3 to 71.8% among pathology departments (P < 0.0001) and from 49.3 to 65.6% over the years (P < 0.0001). In comparison, HER2 positivity rates ranged from 11.8 to 17.2% among departments (P < 0.0001) and from 12.6 to 15.7% over the years (P = 0.005). In the eight departments with the highest number of patients, variability in HER2-low cases increased from 2011 to 2019, although the same immunohistochemical assay was used. By multivariable logistic regression, the examining department was significantly related to both HER2 score 0 and HER2 positivity (P < 0.0001) but showed greater dispersion in odds ratios in the former case (range 0.25-1.41 vs. 0.84-1.27).
conclusionsOur data showed high inter-laboratory variability in the assessment of HER2-low breast cancer. The findings cast doubt on whether the current test method for HER2 is robust and reliable enough to select HER2-low patients for HER2-targeted treatment in daily clinical practice.
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