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ELISA-like QDB method to meet the emerging need of Her2 assessment for breast cancer patients

Inherent issues of subjectivity and inconsistency have long plagued immunohistochemistry (IHC)-based Her2 assessment, leading to the repeated issuance of guidelines by the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) for its standardization for breast cancer pati...

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Autores principales: Yu, Guohua, Lyu, Yan, Jiang, Lei, Wang, Yunjun, Yin, Ying, Zhang, Jiandi, Yang, Maozhou, Tang, Fangrong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10036774/
https://www.ncbi.nlm.nih.gov/pubmed/36969021
http://dx.doi.org/10.3389/fonc.2023.920698
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author Yu, Guohua
Lyu, Yan
Jiang, Lei
Wang, Yunjun
Yin, Ying
Zhang, Jiandi
Yang, Maozhou
Tang, Fangrong
author_facet Yu, Guohua
Lyu, Yan
Jiang, Lei
Wang, Yunjun
Yin, Ying
Zhang, Jiandi
Yang, Maozhou
Tang, Fangrong
author_sort Yu, Guohua
collection PubMed
description Inherent issues of subjectivity and inconsistency have long plagued immunohistochemistry (IHC)-based Her2 assessment, leading to the repeated issuance of guidelines by the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) for its standardization for breast cancer patients. Yet, all these efforts may prove insufficient with the advent of Trastuzumab deruxtecan (T-Dxd), a drug with the promise to expand to tumors traditionally defined as Her2 negative (Her2−). In this study, we attempted to address these issues by exploring an ELISA-like quantitative dot blot (QDB) method as an alternative to IHC. The QDB method has been used to measure multiple protein biomarkers including ER, PR, Ki67, and cyclin D1 in breast cancer specimens. Using an independent cohort (cohort 2) of breast cancer formalin-fixed paraffin-embedded (FFPE) specimens, we validated cutoffs developed in cohort 1 (Yu et al., Scientific Reports 2020 10:10502) with overall 100% specificity (95% CI: 100–100) and 97.56% sensitivity (95% CI: 92.68–100) in cohort 2 against standard practice with the dichotomized absolutely quantitated values. Using the limit of detection (LOD) of the QDB method as the putative cutoff point, tumors with no Her2 expression were identified with the number comparable to those of IHC 0. Our results support further evaluation of the QDB method as an alternative to IHC to meet the emerging need of identifying tumors with low Her2 expression (Her2-low) in daily clinical practice.
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spelling pubmed-100367742023-03-25 ELISA-like QDB method to meet the emerging need of Her2 assessment for breast cancer patients Yu, Guohua Lyu, Yan Jiang, Lei Wang, Yunjun Yin, Ying Zhang, Jiandi Yang, Maozhou Tang, Fangrong Front Oncol Oncology Inherent issues of subjectivity and inconsistency have long plagued immunohistochemistry (IHC)-based Her2 assessment, leading to the repeated issuance of guidelines by the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) for its standardization for breast cancer patients. Yet, all these efforts may prove insufficient with the advent of Trastuzumab deruxtecan (T-Dxd), a drug with the promise to expand to tumors traditionally defined as Her2 negative (Her2−). In this study, we attempted to address these issues by exploring an ELISA-like quantitative dot blot (QDB) method as an alternative to IHC. The QDB method has been used to measure multiple protein biomarkers including ER, PR, Ki67, and cyclin D1 in breast cancer specimens. Using an independent cohort (cohort 2) of breast cancer formalin-fixed paraffin-embedded (FFPE) specimens, we validated cutoffs developed in cohort 1 (Yu et al., Scientific Reports 2020 10:10502) with overall 100% specificity (95% CI: 100–100) and 97.56% sensitivity (95% CI: 92.68–100) in cohort 2 against standard practice with the dichotomized absolutely quantitated values. Using the limit of detection (LOD) of the QDB method as the putative cutoff point, tumors with no Her2 expression were identified with the number comparable to those of IHC 0. Our results support further evaluation of the QDB method as an alternative to IHC to meet the emerging need of identifying tumors with low Her2 expression (Her2-low) in daily clinical practice. Frontiers Media S.A. 2023-03-10 /pmc/articles/PMC10036774/ /pubmed/36969021 http://dx.doi.org/10.3389/fonc.2023.920698 Text en Copyright © 2023 Yu, Lyu, Jiang, Wang, Yin, Zhang, Yang and Tang https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Oncology
Yu, Guohua
Lyu, Yan
Jiang, Lei
Wang, Yunjun
Yin, Ying
Zhang, Jiandi
Yang, Maozhou
Tang, Fangrong
ELISA-like QDB method to meet the emerging need of Her2 assessment for breast cancer patients
title ELISA-like QDB method to meet the emerging need of Her2 assessment for breast cancer patients
title_full ELISA-like QDB method to meet the emerging need of Her2 assessment for breast cancer patients
title_fullStr ELISA-like QDB method to meet the emerging need of Her2 assessment for breast cancer patients
title_full_unstemmed ELISA-like QDB method to meet the emerging need of Her2 assessment for breast cancer patients
title_short ELISA-like QDB method to meet the emerging need of Her2 assessment for breast cancer patients
title_sort elisa-like qdb method to meet the emerging need of her2 assessment for breast cancer patients
topic Oncology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10036774/
https://www.ncbi.nlm.nih.gov/pubmed/36969021
http://dx.doi.org/10.3389/fonc.2023.920698
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