Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American society of clinical oncology/college of American pathologists clinical practice guideline update

Antonio C. Wolff, M. Elizabeth H Hammond, David G. Hicks, Mitch Dowsett, Lisa M. McShane, Kimberly H. Allison, Donald C. Allred, John M S Bartlett, Michael Bilous, Patrick Fitzgibbons, Wedad Hanna, Robert Brian Jenkins, Pamela B. Mangu, Soonmyung Paik, Edith A. Perez, Michael F. Press, Patricia A. Spears, Gail H. Vance, Giuseppe Viale, Daniel F. Hayes

Research output: Contribution to journalArticle

525 Citations (Scopus)

Abstract

Purpose. To update the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for human epidermal growth factor receptor 2 (HER2) testing in breast cancer to improve the accuracy of HER2 testing and its utility as a predictive marker in invasive breast cancer. Methods. ASCO/CAP convened an Update Committee that included coauthors of the 2007 guideline to conduct a systematic literature review and update recommendations for optimal HER2 testing. Results. The Update Committee identified criteria and areas requiring clarification to improve the accuracy of HER2 testing by immunohistochemistry (IHC) or in situ hybridization (ISH). The guideline was reviewed and approved by both organizations. Recommendations. The Update Committee recommends that HER2 status (HER2 negative or positive) be determined in all patientswith invasive (early stage or recurrence) breast cancer on the basis of one or more HER2 test results (negative, equivocal, or positive). Testing criteria define HER2-positive status when (on observing within an area of tumor that amounts to >10% of contiguous and homogeneous tumor cells) there is evidence of protein overexpression (IHC) or gene amplification (HER2 copy number or HER2/CEP17 ratio by ISH based on counting at least 20 cells within the area). If results are equivocal (revised criteria), reflex testing should be performed using an alternative assay (IHC or ISH). Repeat testing should be considered if results seem discordant with other histopathologic findings. Laboratories should demonstrate high concordance with a validated HER2 test on a sufficiently large and representative set of specimens. Testing must be performed in a laboratory accredited by CAP or another accrediting entity. The Update Committee urges providers and health systems to cooperate to ensure the highest quality testing.

Original languageEnglish (US)
Pages (from-to)241-256
Number of pages16
JournalArchives of Pathology and Laboratory Medicine
Volume138
Issue number2
DOIs
StatePublished - Feb 2014

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Medical Oncology
Practice Guidelines
Breast Neoplasms
In Situ Hybridization
Immunohistochemistry
Guidelines
human ERBB2 protein
Pathologists
Gene Amplification
Reflex
Neoplasms

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Medical Laboratory Technology

Cite this

Recommendations for human epidermal growth factor receptor 2 testing in breast cancer : American society of clinical oncology/college of American pathologists clinical practice guideline update. / Wolff, Antonio C.; Hammond, M. Elizabeth H; Hicks, David G.; Dowsett, Mitch; McShane, Lisa M.; Allison, Kimberly H.; Allred, Donald C.; Bartlett, John M S; Bilous, Michael; Fitzgibbons, Patrick; Hanna, Wedad; Jenkins, Robert Brian; Mangu, Pamela B.; Paik, Soonmyung; Perez, Edith A.; Press, Michael F.; Spears, Patricia A.; Vance, Gail H.; Viale, Giuseppe; Hayes, Daniel F.

In: Archives of Pathology and Laboratory Medicine, Vol. 138, No. 2, 02.2014, p. 241-256.

Research output: Contribution to journalArticle

Wolff, AC, Hammond, MEH, Hicks, DG, Dowsett, M, McShane, LM, Allison, KH, Allred, DC, Bartlett, JMS, Bilous, M, Fitzgibbons, P, Hanna, W, Jenkins, RB, Mangu, PB, Paik, S, Perez, EA, Press, MF, Spears, PA, Vance, GH, Viale, G & Hayes, DF 2014, 'Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American society of clinical oncology/college of American pathologists clinical practice guideline update', Archives of Pathology and Laboratory Medicine, vol. 138, no. 2, pp. 241-256. https://doi.org/10.5858/arpa.2013-0953-SA
Wolff, Antonio C. ; Hammond, M. Elizabeth H ; Hicks, David G. ; Dowsett, Mitch ; McShane, Lisa M. ; Allison, Kimberly H. ; Allred, Donald C. ; Bartlett, John M S ; Bilous, Michael ; Fitzgibbons, Patrick ; Hanna, Wedad ; Jenkins, Robert Brian ; Mangu, Pamela B. ; Paik, Soonmyung ; Perez, Edith A. ; Press, Michael F. ; Spears, Patricia A. ; Vance, Gail H. ; Viale, Giuseppe ; Hayes, Daniel F. / Recommendations for human epidermal growth factor receptor 2 testing in breast cancer : American society of clinical oncology/college of American pathologists clinical practice guideline update. In: Archives of Pathology and Laboratory Medicine. 2014 ; Vol. 138, No. 2. pp. 241-256.
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abstract = "Purpose. To update the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for human epidermal growth factor receptor 2 (HER2) testing in breast cancer to improve the accuracy of HER2 testing and its utility as a predictive marker in invasive breast cancer. Methods. ASCO/CAP convened an Update Committee that included coauthors of the 2007 guideline to conduct a systematic literature review and update recommendations for optimal HER2 testing. Results. The Update Committee identified criteria and areas requiring clarification to improve the accuracy of HER2 testing by immunohistochemistry (IHC) or in situ hybridization (ISH). The guideline was reviewed and approved by both organizations. Recommendations. The Update Committee recommends that HER2 status (HER2 negative or positive) be determined in all patientswith invasive (early stage or recurrence) breast cancer on the basis of one or more HER2 test results (negative, equivocal, or positive). Testing criteria define HER2-positive status when (on observing within an area of tumor that amounts to >10{\%} of contiguous and homogeneous tumor cells) there is evidence of protein overexpression (IHC) or gene amplification (HER2 copy number or HER2/CEP17 ratio by ISH based on counting at least 20 cells within the area). If results are equivocal (revised criteria), reflex testing should be performed using an alternative assay (IHC or ISH). Repeat testing should be considered if results seem discordant with other histopathologic findings. Laboratories should demonstrate high concordance with a validated HER2 test on a sufficiently large and representative set of specimens. Testing must be performed in a laboratory accredited by CAP or another accrediting entity. The Update Committee urges providers and health systems to cooperate to ensure the highest quality testing.",
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AU - Hammond, M. Elizabeth H

AU - Hicks, David G.

AU - Dowsett, Mitch

AU - McShane, Lisa M.

AU - Allison, Kimberly H.

AU - Allred, Donald C.

AU - Bartlett, John M S

AU - Bilous, Michael

AU - Fitzgibbons, Patrick

AU - Hanna, Wedad

AU - Jenkins, Robert Brian

AU - Mangu, Pamela B.

AU - Paik, Soonmyung

AU - Perez, Edith A.

AU - Press, Michael F.

AU - Spears, Patricia A.

AU - Vance, Gail H.

AU - Viale, Giuseppe

AU - Hayes, Daniel F.

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N2 - Purpose. To update the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for human epidermal growth factor receptor 2 (HER2) testing in breast cancer to improve the accuracy of HER2 testing and its utility as a predictive marker in invasive breast cancer. Methods. ASCO/CAP convened an Update Committee that included coauthors of the 2007 guideline to conduct a systematic literature review and update recommendations for optimal HER2 testing. Results. The Update Committee identified criteria and areas requiring clarification to improve the accuracy of HER2 testing by immunohistochemistry (IHC) or in situ hybridization (ISH). The guideline was reviewed and approved by both organizations. Recommendations. The Update Committee recommends that HER2 status (HER2 negative or positive) be determined in all patientswith invasive (early stage or recurrence) breast cancer on the basis of one or more HER2 test results (negative, equivocal, or positive). Testing criteria define HER2-positive status when (on observing within an area of tumor that amounts to >10% of contiguous and homogeneous tumor cells) there is evidence of protein overexpression (IHC) or gene amplification (HER2 copy number or HER2/CEP17 ratio by ISH based on counting at least 20 cells within the area). If results are equivocal (revised criteria), reflex testing should be performed using an alternative assay (IHC or ISH). Repeat testing should be considered if results seem discordant with other histopathologic findings. Laboratories should demonstrate high concordance with a validated HER2 test on a sufficiently large and representative set of specimens. Testing must be performed in a laboratory accredited by CAP or another accrediting entity. The Update Committee urges providers and health systems to cooperate to ensure the highest quality testing.

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