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...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2023-03-01
|
| Series: | Frontiers in Oncology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2023.920698/full |
| _version_ | 1811155458546728960 |
|---|---|
| author | Guohua Yu Yan Lyu Lei Jiang Yunjun Wang Ying Yin Jiandi Zhang Maozhou Yang Fangrong Tang |
| author_facet | Guohua Yu Yan Lyu Lei Jiang Yunjun Wang Ying Yin Jiandi Zhang Maozhou Yang Fangrong Tang |
| author_sort | Guohua Yu |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-04-10T04:34:17Z |
| format | Article |
| id | doaj.art-e0679c8344d74381b1f44d5edb53b0fd |
| institution | Directory Open Access Journal |
| issn | 2234-943X |
| language | English |
| last_indexed | 2024-04-10T04:34:17Z |
| publishDate | 2023-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Oncology |
| spelling | doaj.art-e0679c8344d74381b1f44d5edb53b0fd2023-03-10T05:23:33ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2023-03-011310.3389/fonc.2023.920698920698ELISA-like QDB method to meet the emerging need of Her2 assessment for breast cancer patientsGuohua Yu0Yan Lyu1Lei Jiang2Yunjun Wang3Ying Yin4Jiandi Zhang5Maozhou Yang6Fangrong Tang7Laboratory of Molecular Pathology, Department of Pathology, Affiliated Yantai Yuhuangding Hospital, Qingdao University, Yantai, Shandong, ChinaYantai Quanticision Diagnostics, Inc., a Division of Quanticision Diagnostics, Inc. (US), Yantai, Shandong, ChinaLaboratory of Molecular Pathology, Department of Pathology, Affiliated Yantai Yuhuangding Hospital, Qingdao University, Yantai, Shandong, ChinaLaboratory of Molecular Pathology, Department of Pathology, Affiliated Yantai Yuhuangding Hospital, Qingdao University, Yantai, Shandong, ChinaLaboratory of Molecular Pathology, Department of Pathology, Affiliated Yantai Yuhuangding Hospital, Qingdao University, Yantai, Shandong, ChinaYantai Quanticision Diagnostics, Inc., a Division of Quanticision Diagnostics, Inc. (US), Yantai, Shandong, ChinaYantai Quanticision Diagnostics, Inc., a Division of Quanticision Diagnostics, Inc. (US), Yantai, Shandong, ChinaYantai Quanticision Diagnostics, Inc., a Division of Quanticision Diagnostics, Inc. (US), Yantai, Shandong, ChinaInherent 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.https://www.frontiersin.org/articles/10.3389/fonc.2023.920698/fullHER2QDBFFPELODHER2-lowELISA |
| spellingShingle | Guohua Yu Yan Lyu Lei Jiang Yunjun Wang Ying Yin Jiandi Zhang Maozhou Yang Fangrong Tang ELISA-like QDB method to meet the emerging need of Her2 assessment for breast cancer patients Frontiers in Oncology HER2 QDB FFPE LOD HER2-low ELISA |
| 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 | HER2 QDB FFPE LOD HER2-low ELISA |
| url | https://www.frontiersin.org/articles/10.3389/fonc.2023.920698/full |
| work_keys_str_mv | AT guohuayu elisalikeqdbmethodtomeettheemergingneedofher2assessmentforbreastcancerpatients AT yanlyu elisalikeqdbmethodtomeettheemergingneedofher2assessmentforbreastcancerpatients AT leijiang elisalikeqdbmethodtomeettheemergingneedofher2assessmentforbreastcancerpatients AT yunjunwang elisalikeqdbmethodtomeettheemergingneedofher2assessmentforbreastcancerpatients AT yingyin elisalikeqdbmethodtomeettheemergingneedofher2assessmentforbreastcancerpatients AT jiandizhang elisalikeqdbmethodtomeettheemergingneedofher2assessmentforbreastcancerpatients AT maozhouyang elisalikeqdbmethodtomeettheemergingneedofher2assessmentforbreastcancerpatients AT fangrongtang elisalikeqdbmethodtomeettheemergingneedofher2assessmentforbreastcancerpatients |