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High inter-laboratory variability in the assessment of HER2-low breast cancer: a national registry study on 50,714 Danish patients

BACKGROUND: Considering 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. METHODS: Fro...

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Autores principales: Nielsen, Kåre, Sode, Michael, Jensen, Maj-Britt, Berg, Tobias, Knoop, Ann, Ejlertsen, Bent, Lænkholm, Anne-Vibeke
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10636935/
https://www.ncbi.nlm.nih.gov/pubmed/37946261
http://dx.doi.org/10.1186/s13058-023-01739-9
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author Nielsen, Kåre
Sode, Michael
Jensen, Maj-Britt
Berg, Tobias
Knoop, Ann
Ejlertsen, Bent
Lænkholm, Anne-Vibeke
author_facet Nielsen, Kåre
Sode, Michael
Jensen, Maj-Britt
Berg, Tobias
Knoop, Ann
Ejlertsen, Bent
Lænkholm, Anne-Vibeke
author_sort Nielsen, Kåre
collection PubMed
description BACKGROUND: Considering 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. METHODS: From 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. RESULTS: Of 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). CONCLUSIONS: Our 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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spelling pubmed-106369352023-11-11 High inter-laboratory variability in the assessment of HER2-low breast cancer: a national registry study on 50,714 Danish patients Nielsen, Kåre Sode, Michael Jensen, Maj-Britt Berg, Tobias Knoop, Ann Ejlertsen, Bent Lænkholm, Anne-Vibeke Breast Cancer Res Research BACKGROUND: Considering 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. METHODS: From 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. RESULTS: Of 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). CONCLUSIONS: Our 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. BioMed Central 2023-11-09 2023 /pmc/articles/PMC10636935/ /pubmed/37946261 http://dx.doi.org/10.1186/s13058-023-01739-9 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Nielsen, Kåre
Sode, Michael
Jensen, Maj-Britt
Berg, Tobias
Knoop, Ann
Ejlertsen, Bent
Lænkholm, Anne-Vibeke
High inter-laboratory variability in the assessment of HER2-low breast cancer: a national registry study on 50,714 Danish patients
title High inter-laboratory variability in the assessment of HER2-low breast cancer: a national registry study on 50,714 Danish patients
title_full High inter-laboratory variability in the assessment of HER2-low breast cancer: a national registry study on 50,714 Danish patients
title_fullStr High inter-laboratory variability in the assessment of HER2-low breast cancer: a national registry study on 50,714 Danish patients
title_full_unstemmed High inter-laboratory variability in the assessment of HER2-low breast cancer: a national registry study on 50,714 Danish patients
title_short High inter-laboratory variability in the assessment of HER2-low breast cancer: a national registry study on 50,714 Danish patients
title_sort high inter-laboratory variability in the assessment of her2-low breast cancer: a national registry study on 50,714 danish patients
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10636935/
https://www.ncbi.nlm.nih.gov/pubmed/37946261
http://dx.doi.org/10.1186/s13058-023-01739-9
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