Clinical relevance and concordance of HER2 status in local and central testing: an analysis of 1581 HER2-positive breast carcinomas over 12 years
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 diagnos...
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| Hauptverfasser: | , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
April 2018
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| In: |
Modern pathology
Year: 2018, Jahrgang: 31, Heft: 4, Pages: 607-615 |
| ISSN: | 1530-0285 |
| DOI: | 10.1038/modpathol.2017.171 |
| Online-Zugang: | Verlag, Volltext: http://dx.doi.org/10.1038/modpathol.2017.171 Verlag, Volltext: https://www.nature.com/articles/modpathol2017171 
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| Verfasserangaben: | Berit M. Pfitzner, Bianca Lederer, Judith Lindner, Christine Solbach, Knut Engels, Mahdi Rezai, Karel Dohnal, Hans Tesch, Martin L. Hansmann, Christoph Salat, Michaela Beer, Andreas Schneeweiss, Peter Sinn, Agnes Bankfalvi, Silvia Darb-Esfahani, Gunter von Minckwitz, Bruno V. Sinn, Ralf Kronenwett, Karsten Weber, Carsten Denkert, & Sibylle Loibl |
| Zusammenfassung: | 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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| Beschreibung: | Published: 22 December 2017 Gesehen am 15.11.2018 |
| Beschreibung: | Online Resource |
| ISSN: | 1530-0285 |
| DOI: | 10.1038/modpathol.2017.171 |