ArticleModern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc2018
Clinical relevance and concordance of HER2 status in local and central testing-an analysis of 1581 HER2-positive breast carcinomas over 12 years.
Article in Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
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Who cites it
24 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
- Trastuzumab deruxtecan in HER2-expressing gynecologic cancers from DESTINY-PanTumor02: antitumor activity, safety, and exploratory biomarker analyses.Journal of gynecologic oncology · 2026Trial
- Detection of HER2 expression usingBreast cancer research : BCR · 2024Trial
- How artificial intelligence applied to digital pathology could guide treatment personalization in breast cancer.ESMO real world data and digital oncology · 2026Review
- The 19th St. Gallen international breast cancer conference 'primary therapy of patients with early breast cancer. Evidence, controversies, consensus': key moments and breakthroughs.Ecancermedicalscience · 2026Article
- Validation and Prospective Testing of a High-Sensitivity, Quantitative Analytic Assay for HER2 on Histopathology Slides.Laboratory investigation; a journal of technical methods and pathology · 2025Article
- Current status and challenges in HER2 IHC assessment: scoring survey results in Japan.Breast cancer research and treatment · 2025Article
- New treatment options for metastatic HER2-low breast cancer : Consequences for histopathological diagnosis.Pathologie (Heidelberg, Germany) · 2023Review
- Concordance of microsatellite instability and mismatch repair status in paired biopsies and surgical specimens of resectable gastroesophageal adenocarcinoma: time for a call to action.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2023Article
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- Multi-institutional Assessment of Pathologist Scoring HER2 Immunohistochemistry.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2023Article
- [New treatment options for metastatic HER2-low breast cancer : Consequences for histopathological diagnosis].Pathologie (Heidelberg, Germany) · 2022Review
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- Loss of HER2 in breast cancer: biological mechanisms and technical pitfalls.Cancer drug resistance (Alhambra, Calif.) · 2022Article
- Quantification of Human Epidermal Growth Factor Receptor 2 by Immunopeptide Enrichment and Targeted Mass Spectrometry in Formalin-Fixed Paraffin-Embedded and Frozen Breast Cancer Tissues.Clinical chemistry · 2021Article
- Assessment of Ki67 in Breast Cancer: Updated Recommendations From the International Ki67 in Breast Cancer Working Group.Journal of the National Cancer Institute · 2021Article
- Looking for more reliable biomarkers in breast cancer: Comparison between routine methods and RT-qPCR.PloS one · 2021Article
- Estrogen, progesterone, and human epidermal growth factor receptor 2 discordance between primary and metastatic breast cancer.Breast cancer research and treatment · 2020Article
- Local and Central Evaluation of HER2 Positivity and Clinical Outcome in Advanced Gastric and Gastroesophageal Cancer-Results from the AGMT GASTRIC-5 Registry.Journal of clinical medicine · 2020Article
Corrections and comments
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Authors and funding
21 authors.
Funding
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Abstract
Human epidermal growth factor receptor 2 (HER2) is a central predictive biomarker in breast cancer. Inaccurate HER2 results in different laboratories could be as high as 20%. However, this statement is based on data generated more than 13 years ago and may not reflect the standards of modern diagnostic pathology. We compared central and local HER2 testing in a total of 1581 HER2-positive tumors from five clinical trials. We evaluated the clinical relevance for pathological complete response (pCR) and disease-free survival in a subgroup of 677 tumors, which received an anti-HER2 therapy. Over the period of 12 years, the discordance rate for HER2 decreased from 52.4 (GeparTrio) to 8.4% (GeparSepto). Discordance rates were significantly higher in hormone receptor (HR)-positive tumors (26.6%), compared to HR-negative tumors (16.3%, P<0.0001), which could be explained by a different distribution of HER2 mRNA levels in HR-positive and HR-negative tumors. pCR rates were significantly lower in discordant tumors (13.7%) compared to concordant tumors (32.2%, GeparQuattro and GeparQuinto, P<0.001). In survival analysis, tumors with discordant HER2 testing had a reduced overall survival (OS) in the HR-negative group (P=0.019) and a trend for improved OS in the HR-positive group (P=0.125). The performance of local HER2 testing was considerably improved over time and has reached a 92% concordance, which shows that quality initiatives in diagnostic pathology are working. Tumors with discordant HER2 testing had a reduced therapy response and different survival rates.
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