Assessment of HER2 testing patterns, HER2+ disease, and the utilization of HER2-directed therapy in early breast cancer

David D Stenehjem,1,2 Minkyoung Yoo,1 Sudhir K Unni,1 Mukul Singhal,1 Hillevi Bauer,1 Kim Saverno,1 Cheng Quah,3 Anthony Masaquel,3 Diana I Brixner1,41Pharmacotherapy Outcomes Research Center (PORC), College of Pharmacy, University of Utah, Salt Lake City, UT, USA; 2Huntsman Cancer Institute, Salt...

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Autores principales: Stenehjem DD, Yoo M, Unni SK, Singhal M, Bauer H, Saverno K, Quah C, Masaquel A, Brixner DI
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Publicado: Dove Medical Press 2014
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spelling oai:doaj.org-article:d20a95d5003542918f52ce0ae90528462021-12-02T01:56:20ZAssessment of HER2 testing patterns, HER2+ disease, and the utilization of HER2-directed therapy in early breast cancer1179-1314https://doaj.org/article/d20a95d5003542918f52ce0ae90528462014-10-01T00:00:00Zhttp://www.dovepress.com/assessment-of-her2-testing-patterns-her2-disease-and-the-utilization-o-peer-reviewed-article-BCTThttps://doaj.org/toc/1179-1314 David D Stenehjem,1,2 Minkyoung Yoo,1 Sudhir K Unni,1 Mukul Singhal,1 Hillevi Bauer,1 Kim Saverno,1 Cheng Quah,3 Anthony Masaquel,3 Diana I Brixner1,41Pharmacotherapy Outcomes Research Center (PORC), College of Pharmacy, University of Utah, Salt Lake City, UT, USA; 2Huntsman Cancer Institute, Salt Lake City, UT, USA; 3Genentech, Inc., South San Francisco, CA, USA; 4Program in Personalized Health Care, University of Utah, Salt Lake City, UT, USAContext: Determining human epidermal growth factor receptor 2 (HER2) status is critical for the management of early-stage breast cancer (ESBC). An understanding of HER2 testing practices can provide insight into how test results influence the use of HER2-directed therapy.Objective: To assess HER2 testing, HER2+ disease, and HER2-directed therapy in ESBC at the Huntsman Cancer Institute before and after the 2007 American Society of Clinical Oncology and College of American Pathologist (ASCO/CAP) guidelines on HER2 testing were published.Methods: Patients were identified from an institutional tumor registry. HER2 testing patterns and results were examined using a chart review of pathology and clinical notes. Patient characteristics, HER2+ rate, and trastuzumab use were evaluated descriptively. Discordance rate with reflex testing (immunohistochemistry [IHC]2+ retested by fluorescence in situ hybridization [FISH]) was also evaluated.Results: A total of 1,459 women were included (mean age: 57 years). The rate of HER2+ disease was 17% (number [N] =245). The discordance rate between IHC2+ and FISH was 10%. After the 2007 ASCO/CAP guidelines, fewer tumors were classified as IHC3+ (16% post- versus 21.9% pre-2007), more tumors were characterized as IHC2+ (26.4% post- versus 20.7% pre-2007), and the overall HER2+ rate was decreased (18.7% versus 21.9%), but this was not statistically significant (P=0.519). Most patients with HER2+ ESBC received HER2-targeted therapy (N=185).Conclusion: The HER2+ rate was 17% and within the range of the reported rates in the literature. Reflex testing identified additional HER2+ tumors by approximately 10%, and should be considered a potential quality indicator. ASCO/CAP HER2 testing guidelines in 2007 appeared to impact the interpretation and classification of HER2+ tumors.Keywords: human epidermal growth factor receptor 2, HER2, early-stage breast cancer, immunohistochemistry, FISH, HER2-targeted therapyStenehjem DDYoo MUnni SKSinghal MBauer HSaverno KQuah CMasaquel ABrixner DIDove Medical PressarticleNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENBreast Cancer: Targets and Therapy, Vol 2014, Iss default, Pp 169-177 (2014)
institution DOAJ
collection DOAJ
language EN
topic Neoplasms. Tumors. Oncology. Including cancer and carcinogens
RC254-282
spellingShingle Neoplasms. Tumors. Oncology. Including cancer and carcinogens
RC254-282
Stenehjem DD
Yoo M
Unni SK
Singhal M
Bauer H
Saverno K
Quah C
Masaquel A
Brixner DI
Assessment of HER2 testing patterns, HER2+ disease, and the utilization of HER2-directed therapy in early breast cancer
description David D Stenehjem,1,2 Minkyoung Yoo,1 Sudhir K Unni,1 Mukul Singhal,1 Hillevi Bauer,1 Kim Saverno,1 Cheng Quah,3 Anthony Masaquel,3 Diana I Brixner1,41Pharmacotherapy Outcomes Research Center (PORC), College of Pharmacy, University of Utah, Salt Lake City, UT, USA; 2Huntsman Cancer Institute, Salt Lake City, UT, USA; 3Genentech, Inc., South San Francisco, CA, USA; 4Program in Personalized Health Care, University of Utah, Salt Lake City, UT, USAContext: Determining human epidermal growth factor receptor 2 (HER2) status is critical for the management of early-stage breast cancer (ESBC). An understanding of HER2 testing practices can provide insight into how test results influence the use of HER2-directed therapy.Objective: To assess HER2 testing, HER2+ disease, and HER2-directed therapy in ESBC at the Huntsman Cancer Institute before and after the 2007 American Society of Clinical Oncology and College of American Pathologist (ASCO/CAP) guidelines on HER2 testing were published.Methods: Patients were identified from an institutional tumor registry. HER2 testing patterns and results were examined using a chart review of pathology and clinical notes. Patient characteristics, HER2+ rate, and trastuzumab use were evaluated descriptively. Discordance rate with reflex testing (immunohistochemistry [IHC]2+ retested by fluorescence in situ hybridization [FISH]) was also evaluated.Results: A total of 1,459 women were included (mean age: 57 years). The rate of HER2+ disease was 17% (number [N] =245). The discordance rate between IHC2+ and FISH was 10%. After the 2007 ASCO/CAP guidelines, fewer tumors were classified as IHC3+ (16% post- versus 21.9% pre-2007), more tumors were characterized as IHC2+ (26.4% post- versus 20.7% pre-2007), and the overall HER2+ rate was decreased (18.7% versus 21.9%), but this was not statistically significant (P=0.519). Most patients with HER2+ ESBC received HER2-targeted therapy (N=185).Conclusion: The HER2+ rate was 17% and within the range of the reported rates in the literature. Reflex testing identified additional HER2+ tumors by approximately 10%, and should be considered a potential quality indicator. ASCO/CAP HER2 testing guidelines in 2007 appeared to impact the interpretation and classification of HER2+ tumors.Keywords: human epidermal growth factor receptor 2, HER2, early-stage breast cancer, immunohistochemistry, FISH, HER2-targeted therapy
format article
author Stenehjem DD
Yoo M
Unni SK
Singhal M
Bauer H
Saverno K
Quah C
Masaquel A
Brixner DI
author_facet Stenehjem DD
Yoo M
Unni SK
Singhal M
Bauer H
Saverno K
Quah C
Masaquel A
Brixner DI
author_sort Stenehjem DD
title Assessment of HER2 testing patterns, HER2+ disease, and the utilization of HER2-directed therapy in early breast cancer
title_short Assessment of HER2 testing patterns, HER2+ disease, and the utilization of HER2-directed therapy in early breast cancer
title_full Assessment of HER2 testing patterns, HER2+ disease, and the utilization of HER2-directed therapy in early breast cancer
title_fullStr Assessment of HER2 testing patterns, HER2+ disease, and the utilization of HER2-directed therapy in early breast cancer
title_full_unstemmed Assessment of HER2 testing patterns, HER2+ disease, and the utilization of HER2-directed therapy in early breast cancer
title_sort assessment of her2 testing patterns, her2+ disease, and the utilization of her2-directed therapy in early breast cancer
publisher Dove Medical Press
publishDate 2014
url https://doaj.org/article/d20a95d5003542918f52ce0ae9052846
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