ArticleBreast cancer research : BCR2015
Quantitative measurement of HER2 expression in breast cancers: comparison with 'real-world' routine HER2 testing in a multicenter Collaborative Biomarker Study and correlation with overall survival.
Article in Breast cancer research : BCR, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.
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Who cites it
27 citing papers in PubMed, 45 citations in OpenAlex.
- Right-sizing treatment for HER2-positive breast cancer: evolving algorithms across the disease continuum.Nature reviews. Clinical oncology · 2026Review
- Advances in Targeting HER2 across Cancer Subtypes: A Pan-Tumor Approach.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Review
- HER2 expression in breast cancer: evidence gaps and challenges.NPJ precision oncology · 2025Review
- Dual HER2 inhibition: mechanisms of synergy, patient selection, and resistance.Nature reviews. Clinical oncology · 2024Review
- Fully Automated Artificial Intelligence Solution for Human Epidermal Growth Factor Receptor 2 Immunohistochemistry Scoring in Breast Cancer: A Multireader Study.JCO precision oncology · 2024Article
- Immunohistochemical assessment of HER2 low breast cancer: interobserver reproducibility and correlation with digital image analysis.Breast cancer research and treatment · 2024Article
- Open questions, current challenges, and future perspectives in targeting human epidermal growth factor receptor 2-low breast cancer.ESMO open · 2024Review
- Novel approach to HER2 quantification using phosphor-integrated dots in human breast invasive cancer microarray.PloS one · 2024Article
- Brain Radiotherapy Combined with Targeted Therapy for HER2-Positive Breast Cancer Patients with Brain Metastases.Breast cancer (Dove Medical Press) · 2024Article
- HER2-Low Breast Cancer-Diagnostic Challenges and Opportunities for Insights from Ongoing Studies: A Podcast.Targeted oncology · 2023Article
- Unlocking the Resistance to Anti-HER2 Treatments in Breast Cancer: The Issue of HER2 Spatial Distribution.Cancers · 2023Review
- ELISA-like QDB method to meet the emerging need of Her2 assessment for breast cancer patients.Frontiers in oncology · 2023Article
- The HER2-low revolution in breast oncology: steps forward and emerging challenges.Therapeutic advances in medical oncology · 2023Review
- Review
- Targeted Approaches to HER2-Low Breast Cancer: Current Practice and Future Directions.Cancers · 2022Review
- HER2-low-positive breast cancer: evolution from primary tumor to residual disease after neoadjuvant treatment.NPJ breast cancer · 2022Article
- Diffusion kernel-based predictive modeling of KRAS dependency in KRAS wild type cancer cell lines.NPJ systems biology and applications · 2022Article
- Simulating the Selection of Resistant Cells with Bystander Killing and Antibody Coadministration in Heterogeneous Human Epidermal Growth Factor Receptor 2-Positive Tumors.Drug metabolism and disposition: the biological fate of chemicals · 2022Article
- Evolution of HER2-low expression from primary to recurrent breast cancer.NPJ breast cancer · 2021Article
- PD-L1 quantification across tumor types using the reverse phase protein microarray: implications for precision medicine.Journal for immunotherapy of cancer · 2021Article
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Authors and funding
21 authors at 9 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionAccurate assessment of HER2 status is critical in determining appropriate therapy for breast cancer patients but the best HER2 testing methodology has yet to be defined. In this study, we compared quantitative HER2 expression by the HERmark™ Breast Cancer Assay (HERmark) with routine HER2 testing by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH), and correlated HER2 results with overall survival (OS) of breast cancer patients in a multicenter Collaborative Biomarker Study (CBS).
methodsTwo hundred and thirty-two formalin-fixed, paraffin-embedded breast cancer tissues and local laboratory HER2 testing results were provided by 11 CBS sites. HERmark assay and central laboratory HER2 IHC retesting were retrospectively performed in a blinded fashion. HER2 results by all testing methods were obtained in 192 cases.
resultsHERmark yielded a continuum of total HER2 expression (H2T) ranging from 0.3 to 403 RF/mm2 (approximately 3 logs). The distribution of H2T levels correlated significantly (P<0.0001) with all routine HER2 testing results. The concordance of positive and negative values (equivocal cases excluded) between HERmark and routine HER2 testing was 84% for local IHC, 96% for central IHC, 85% for local FISH, and 84% for local HER2 status. OS analysis revealed a significant correlation of shorter OS with HER2 positivity by local IHC (HR=2.6, P=0.016), central IHC (HR=3.2, P=0.015), and HERmark (HR=5.1, P<0.0001) in this cohort of patients most of whom received no HER2-targeted therapy. The OS curve of discordant low (HER2 positive but H2T low, 10% of all cases) was aligned with concordant negative (HER2 negative and H2T low, HR=1.9, P=0.444), but showed a significantly longer OS than concordant positive (HER2 positive and H2T high, HR=0.31, P=0.024). Conversely, the OS curve of discordant high (HER2 negative but H2T high, 9% of all cases) was aligned with concordant positive (HR=0.41, P=0.105), but showed a significantly shorter OS than concordant negative (HR=41, P<0.0001).
conclusionsQuantitative HER2 measurement by HERmark is highly sensitive, accurately quantifies HER2 protein expression and correlates well with routine HER2 testing. When HERmark and local HER2 results were discordant, HERmark more accurately predicted overall survival.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.