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Quality assessment of HER2 testing by monitoring of positivity rates

Interlaboratory variation in human epidermal growth factor receptor 2 (HER2) testing provides a challenge for targeted therapy in breast and gastric cancer. Assessment of positivity rates among laboratories could help monitor their performance and define reference values for positivity rates to be e...

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Autores principales: Choritz, Harald, Büsche, Guntram, Kreipe, Hans
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer-Verlag 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3162627/
https://www.ncbi.nlm.nih.gov/pubmed/21809092
http://dx.doi.org/10.1007/s00428-011-1132-8
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author Choritz, Harald
Büsche, Guntram
Kreipe, Hans
author_facet Choritz, Harald
Büsche, Guntram
Kreipe, Hans
author_sort Choritz, Harald
collection PubMed
description Interlaboratory variation in human epidermal growth factor receptor 2 (HER2) testing provides a challenge for targeted therapy in breast and gastric cancer. Assessment of positivity rates among laboratories could help monitor their performance and define reference values for positivity rates to be expected in a geographic region. Pathologists regularly determined the number of HER2-positive cases (HER2 3+, HER2 2+/amplified or amplified) in their laboratory, and figures were continuously entered into a central website. The overall positivity rate of each participant was calculated and compared with the average rates of all other institutes (n = 42). A total of 18,081 test results on breast cancer and 982 on gastric cancer were entered into the system. Positivity rates for HER2 in breast cancer ranged from 7.6% to 31.6%. Statistically, the results from six institutions qualified as outliers (p < 0.000005). From the remaining institutions encompassing 10,916 assessments, the mean proportion of positive cases was 16.7 ± 3.2% (99% confidence interval 16.6–16.8). The results from six institutions were in between the 95% and 99.5% confidence intervals. For gastric cancer, there was one outlier and the mean positivity rate was 23.2 ± 5.7%. The proportion of HER2-positive breast cancer cases is considerably lower than could have been expected from published studies. By assessing the positivity rates and comparing them with that of all breast or gastric cancers in a given population, pathologists will be alerted to a potential systematic error in their laboratory assay, causative for over- or underestimation of cancer cases suited for anti-HER2 therapy.
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spelling pubmed-31626272011-09-26 Quality assessment of HER2 testing by monitoring of positivity rates Choritz, Harald Büsche, Guntram Kreipe, Hans Virchows Arch Original Article Interlaboratory variation in human epidermal growth factor receptor 2 (HER2) testing provides a challenge for targeted therapy in breast and gastric cancer. Assessment of positivity rates among laboratories could help monitor their performance and define reference values for positivity rates to be expected in a geographic region. Pathologists regularly determined the number of HER2-positive cases (HER2 3+, HER2 2+/amplified or amplified) in their laboratory, and figures were continuously entered into a central website. The overall positivity rate of each participant was calculated and compared with the average rates of all other institutes (n = 42). A total of 18,081 test results on breast cancer and 982 on gastric cancer were entered into the system. Positivity rates for HER2 in breast cancer ranged from 7.6% to 31.6%. Statistically, the results from six institutions qualified as outliers (p < 0.000005). From the remaining institutions encompassing 10,916 assessments, the mean proportion of positive cases was 16.7 ± 3.2% (99% confidence interval 16.6–16.8). The results from six institutions were in between the 95% and 99.5% confidence intervals. For gastric cancer, there was one outlier and the mean positivity rate was 23.2 ± 5.7%. The proportion of HER2-positive breast cancer cases is considerably lower than could have been expected from published studies. By assessing the positivity rates and comparing them with that of all breast or gastric cancers in a given population, pathologists will be alerted to a potential systematic error in their laboratory assay, causative for over- or underestimation of cancer cases suited for anti-HER2 therapy. Springer-Verlag 2011-08-02 2011 /pmc/articles/PMC3162627/ /pubmed/21809092 http://dx.doi.org/10.1007/s00428-011-1132-8 Text en © The Author(s) 2011 https://creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.
spellingShingle Original Article
Choritz, Harald
Büsche, Guntram
Kreipe, Hans
Quality assessment of HER2 testing by monitoring of positivity rates
title Quality assessment of HER2 testing by monitoring of positivity rates
title_full Quality assessment of HER2 testing by monitoring of positivity rates
title_fullStr Quality assessment of HER2 testing by monitoring of positivity rates
title_full_unstemmed Quality assessment of HER2 testing by monitoring of positivity rates
title_short Quality assessment of HER2 testing by monitoring of positivity rates
title_sort quality assessment of her2 testing by monitoring of positivity rates
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3162627/
https://www.ncbi.nlm.nih.gov/pubmed/21809092
http://dx.doi.org/10.1007/s00428-011-1132-8
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