Digital image analysis and assisted reading of the HER2 score display reduced concordance: pitfalls in the categorisation of HER2-low breast cancer
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Aims: Digital image analysis (DIA) is used increasingly as an assisting tool to evaluate biomarkers, including human epidermal growth factor receptor 2 (HER2) in invasive breast cancer (BC). DIA can assist pathologists in HER2 evaluation by presenting quantitative information about the HER2 staining in APP assisted reading (AR). Concurrently, the HER2-low category (HER2-1+/2+ without HER2 gene amplification) has gained prominence due to newly developed antibody-drug conjugates. However, major inter- and intraobserver variability have been observed for the entity. The present quality assurance study investigated the concordance between DIA and AR in clinical use, especially concerning the HER2-low category. Methods and results: HER2 immunohistochemistry (IHC) in 761 tumours from 727 patients was evaluated in tissue microarray (TMA) cores by DIA (Visiopharm HER2-CONNECT) and AR. Overall concordance between HER2-scores were 73% (n = 552, weighted-κ: 0.66), and 88% (n = 669, weighted-κ: 0.70), when combining HER2-0/1+. A total of 205 scores were discordant by one category, while four were discordant by two categories. A heterogeneous HER2 pattern was relatively common in the discordant cases and a pitfall in the categorisation of HER2-low BC. AR more commonly reassigned a lower HER2 score (from HER2-1+ to HER2-0) within the HER2-low subgroup (n = 624) compared with DIA. Conclusion: DIA and AR display moderate agreement with heterogeneous and aberrant staining, representing a source of discordance and a pitfall in the evaluation of HER2.
Originalsprog | Engelsk |
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Tidsskrift | Histopathology |
Vol/bind | 82 |
Udgave nummer | 6 |
Sider (fra-til) | 912-924 |
Antal sider | 13 |
ISSN | 0309-0167 |
DOI | |
Status | Udgivet - 2023 |
Bibliografisk note
Funding Information:
The project was funded by Region Zealand, who supplied a researcher grant (R29‐A1243). The authors thank Tove Aagesen (Department of Pathology, Zealand University Hospital) for her help in extracting the clinical and pathological information. In addition Johan Doré (Visiopharm A/S) and Jamilla Ahdidan (Visiopharm A/S) provided helpful comments about the direction of the project and the interpretation of the dataset.
Publisher Copyright:
© 2023 The Authors. Histopathology published by John Wiley & Sons Ltd.
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