Cargando…
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...
Autores principales: | , , , , , , , |
---|---|
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 |
_version_ | 1784911731034685440 |
---|---|
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. |
format | Online Article Text |
id | pubmed-10036774 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT yuguohua elisalikeqdbmethodtomeettheemergingneedofher2assessmentforbreastcancerpatients AT lyuyan elisalikeqdbmethodtomeettheemergingneedofher2assessmentforbreastcancerpatients AT jianglei elisalikeqdbmethodtomeettheemergingneedofher2assessmentforbreastcancerpatients AT wangyunjun elisalikeqdbmethodtomeettheemergingneedofher2assessmentforbreastcancerpatients AT yinying elisalikeqdbmethodtomeettheemergingneedofher2assessmentforbreastcancerpatients AT zhangjiandi elisalikeqdbmethodtomeettheemergingneedofher2assessmentforbreastcancerpatients AT yangmaozhou elisalikeqdbmethodtomeettheemergingneedofher2assessmentforbreastcancerpatients AT tangfangrong elisalikeqdbmethodtomeettheemergingneedofher2assessmentforbreastcancerpatients |