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American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer

Press, Michael F.; Wolff, Antonio C.; Hammond, M. Elizabeth H.; Schwartz, Jared N.; Hagerty, Karen L.; Allred, D. Craig; Cote, Richard J.; Dowsett, Mitchell; Fitzgibbons, Patrick L.; Hanna, Wedad M.; Langer, Amy; McShane, Lisa M.; Paik, Soonmyung; Pegram, Mark D.; Perez, Edith A.; Rhodes, Anthony; Sturgeon, Catharine; Taube, Sheila E.; Tubbs, Raymond; Vance, Gail H.; Van De Vijver, Marc; Wheeler, Thomas M.; Hayes, Daniel F.

Authors

Michael F. Press

Antonio C. Wolff

M. Elizabeth H. Hammond

Jared N. Schwartz

Karen L. Hagerty

D. Craig Allred

Richard J. Cote

Mitchell Dowsett

Patrick L. Fitzgibbons

Wedad M. Hanna

Amy Langer

Lisa M. McShane

Soonmyung Paik

Mark D. Pegram

Edith A. Perez

Anthony Rhodes

Catharine Sturgeon

Sheila E. Taube

Raymond Tubbs

Gail H. Vance

Marc Van De Vijver

Thomas M. Wheeler

Daniel F. Hayes



Abstract

Purpose: To develop a guideline to improve the accuracy of human epidermal growth factor receptor 2 (HER2) testing in invasive breast cancer and its utility as a predictive marker. Methods: The American Society of Clinical Oncology and the College of American Pathologists convened an expert panel, which conducted a systematic review of the literature and developed recommendations for optimal HER2 testing performance. The guideline was reviewed by selected experts and approved by the board of directors for both organizations. Results: Approximately 20% of current HER2 testing may be inaccurate. When carefully validated testing is performed, available data do not clearly demonstrate the superiority of either immunohistochemistry (IHC) or in situ hybridization (ISH) as a predictor of benefit from anti-HER2 therapy. Recommendations: The panel recommends that HER2 status should be determined for all invasive breast cancer. A testing algorithm that relies on accurate, reproducible assay performance, including newly available types of brightfield ISH, is proposed. Elements to reliably reduce assay variation (for example, specimen handling, assay exclusion, and reporting criteria) are specified. An algorithm defining positive, equivocal, and negative values for both HER2 protein expression and gene amplification is recommended: a positive HER2 result is IHC staining of 3+ (uniform, intense membrane staining of > 30% of invasive tumor cells), a fluorescent in situ hybridization (FISH) result of more than six HER2 gene copies per nucleus or a FISH ratio (HER2 gene signals to chromosome 17 signals) of more than 2.2; a negative result is an IHC staining of 0 or 1+, a FISH result of less than 4.0 HER2 gene copies per nucleus, or FISH ratio of less than 1.8. Equivocal results require additional action for final determination. It is recommended that to perform HER2 testing, laboratories show 95% concordance with another validated test for positive and negative assay values. The panel strongly recommends validation of laboratory assay or modifications, use of standardized operating procedures, and compliance with new testing criteria to be monitored with the use of stringent laboratory accreditation standards, proficiency testing, and competency assessment. The panel recommends that HER2 testing be done in a CAP-accredited laboratory or in a laboratory that meets the accreditation and proficiency testing requirements set out by this document. Copyright © 2007 by the American Society of Clinical Oncology and College of American Pathologists. All rights reserved.

Citation

Press, M. F., Wolff, A. C., Hammond, M. E. H., Schwartz, J. N., Hagerty, K. L., Allred, D. C., …Hayes, D. F. (2007). American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. Journal of Clinical Oncology, 25(1), 118-145. https://doi.org/10.1200/JCO.2006.09.2775

Journal Article Type Review
Publication Date Jan 1, 2007
Journal Journal of Clinical Oncology
Print ISSN 0732-183X
Publisher American Society of Clinical Oncology
Peer Reviewed Peer Reviewed
Volume 25
Issue 1
Pages 118-145
DOI https://doi.org/10.1200/JCO.2006.09.2775
Keywords breast cancer, human epidermal growth factor, receptor 2 testing
Public URL https://uwe-repository.worktribe.com/output/1030502
Publisher URL http://dx.doi.org/10.1200/JCO.2006.09.2775




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