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

Antonio C. Wolff, M. Elizabeth H Hammond, Jared N. Schwartz, Karen L. Hagerty, D. Craig Alfred, Richard J Cote, Mitchell Dowsett, Patrick L. Fitzgibbons, Wedad M. Hanna, Amy Langer, Lisa M. McShane, Soonmyung Paik, Mark D. Pegram, Edith A. Perez, Michael F. Press, Anthony Rhodes, Catharine Sturgeon, Sheila E. Taube, Raymond Tubbs, Gail H. Vance & 3 others Marc Van De Vijver, Thomas M. Wheeler, Daniel F. Hayes

Research output: Contribution to journalArticle

1130 Citations (Scopus)

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 (CAP) 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 6 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 a 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. Tlie 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.

Original languageEnglish
Pages (from-to)18-43
Number of pages26
JournalArchives of Pathology and Laboratory Medicine
Volume131
Issue number1
StatePublished - Jan 1 2007
Externally publishedYes

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Guidelines
Breast Neoplasms
erbB-1 Genes
Fluorescence In Situ Hybridization
Accreditation
Immunohistochemistry
Staining and Labeling
In Situ Hybridization
human ERBB2 protein
Pathologists
Specimen Handling
Chromosomes, Human, Pair 17
Gene Amplification
Membranes

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Medical Laboratory Technology

Cite this

American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. / Wolff, Antonio C.; Hammond, M. Elizabeth H; Schwartz, Jared N.; Hagerty, Karen L.; Alfred, 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.; Press, Michael F.; Rhodes, Anthony; Sturgeon, Catharine; Taube, Sheila E.; Tubbs, Raymond; Vance, Gail H.; Van De Vijver, Marc; Wheeler, Thomas M.; Hayes, Daniel F.

In: Archives of Pathology and Laboratory Medicine, Vol. 131, No. 1, 01.01.2007, p. 18-43.

Research output: Contribution to journalArticle

Wolff, AC, Hammond, MEH, Schwartz, JN, Hagerty, KL, Alfred, DC, Cote, RJ, Dowsett, M, Fitzgibbons, PL, Hanna, WM, Langer, A, McShane, LM, Paik, S, Pegram, MD, Perez, EA, Press, MF, Rhodes, A, Sturgeon, C, Taube, SE, Tubbs, R, Vance, GH, Van De Vijver, M, Wheeler, TM & Hayes, DF 2007, 'American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer', Archives of Pathology and Laboratory Medicine, vol. 131, no. 1, pp. 18-43.
Wolff, Antonio C. ; Hammond, M. Elizabeth H ; Schwartz, Jared N. ; Hagerty, Karen L. ; Alfred, 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. ; Press, Michael F. ; Rhodes, Anthony ; Sturgeon, Catharine ; Taube, Sheila E. ; Tubbs, Raymond ; Vance, Gail H. ; Van De Vijver, Marc ; Wheeler, Thomas M. ; Hayes, Daniel F. / American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. In: Archives of Pathology and Laboratory Medicine. 2007 ; Vol. 131, No. 1. pp. 18-43.
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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 (CAP) 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 6 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 a 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. Tlie 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.",
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AU - Wolff, Antonio C.

AU - Hammond, M. Elizabeth H

AU - Schwartz, Jared N.

AU - Hagerty, Karen L.

AU - Alfred, D. Craig

AU - Cote, Richard J

AU - Dowsett, Mitchell

AU - Fitzgibbons, Patrick L.

AU - Hanna, Wedad M.

AU - Langer, Amy

AU - McShane, Lisa M.

AU - Paik, Soonmyung

AU - Pegram, Mark D.

AU - Perez, Edith A.

AU - Press, Michael F.

AU - Rhodes, Anthony

AU - Sturgeon, Catharine

AU - Taube, Sheila E.

AU - Tubbs, Raymond

AU - Vance, Gail H.

AU - Van De Vijver, Marc

AU - Wheeler, Thomas M.

AU - Hayes, Daniel F.

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N2 - 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 (CAP) 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 6 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 a 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. Tlie 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.

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