Human epidermal growth factor receptor 2 testing in breast cancer

American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update

Antonio C. Wolff, Lisa M. McShane, M. Elizabeth Hale Hammond, Kimberly H. Allison, Patrick Fitzgibbons, Michael F. Press, Brittany E. Harvey, Pamela B. Mangu, John M.S. Bartlett, Wedad Hanna, Michael Bilous, Ian O. Ellis, Mitchell Dowsett, Robert Brian Jenkins, Patricia A. Spears, Gail H. Vance, Giuseppe Viale

Research output: Contribution to journalReview article

29 Citations (Scopus)

Abstract

Purpose. - To update key recommendations of the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) human epidermal growth factor receptor 2 (HER2) testing in breast cancer guideline. Methods. - Based on the signals approach, an Expert Panel reviewed published literature and research survey results on the observed frequency of less common in situ hybridization (ISH) patterns to update the recommendations. Recommendations. - Two recommendations addressed via correspondence in 2015 are included. First, immunohistochemistry (IHC) 2+ is defined as invasive breast cancer with weak to moderate complete membrane staining observed in >10% of tumor cells. Second, if the initial HER2 test result in a core needle biopsy specimen of a primary breast cancer is negative, a new HER2 test may (not ''must'') be ordered on the excision specimen based on specific clinical criteria. The HER2 testing algorithm for breast cancer is updated to address the recommended workup for less common clinical scenarios (approximately 5% of cases) observed when using a dual-probe ISH assay. These scenarios are described as ISH group 2 (HER2/ chromosome enumeration probe 17 [CEP17] ratio ≥2.0; average HER2 copy number <4.0 signals per cell), ISH group 3 (HER2/CEP17 ratio <2.0; average HER2 copy number ≥6.0 signals per cell), and ISH group 4 (HER2/ CEP17 ratio <2.0; average HER2 copy number ≥4.0 and <6.0 signals per cell). The diagnostic approach includes more rigorous interpretation criteria for ISH and requires concomitant IHC review for dual-probe ISH groups 2 to 4 to arrive at the most accurate HER2 status designation (positive or negative) based on combined interpretation of the ISH and IHC assays. The Expert Panel recommends that laboratories using single-probe ISH assays include concomitant IHC review as part of the interpretation of all single-probe ISH assay results.

Original languageEnglish (US)
Pages (from-to)1364-1382
Number of pages19
JournalArchives of Pathology and Laboratory Medicine
Volume142
Issue number11
DOIs
StatePublished - Nov 1 2018

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Practice Guidelines
In Situ Hybridization
Breast Neoplasms
Immunohistochemistry
Chromosomes
human ERBB2 protein
Pathologists
Large-Core Needle Biopsy
Guidelines
Staining and Labeling
Membranes

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Medical Laboratory Technology

Cite this

Human epidermal growth factor receptor 2 testing in breast cancer : American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. / Wolff, Antonio C.; McShane, Lisa M.; Hammond, M. Elizabeth Hale; Allison, Kimberly H.; Fitzgibbons, Patrick; Press, Michael F.; Harvey, Brittany E.; Mangu, Pamela B.; Bartlett, John M.S.; Hanna, Wedad; Bilous, Michael; Ellis, Ian O.; Dowsett, Mitchell; Jenkins, Robert Brian; Spears, Patricia A.; Vance, Gail H.; Viale, Giuseppe.

In: Archives of Pathology and Laboratory Medicine, Vol. 142, No. 11, 01.11.2018, p. 1364-1382.

Research output: Contribution to journalReview article

Wolff, AC, McShane, LM, Hammond, MEH, Allison, KH, Fitzgibbons, P, Press, MF, Harvey, BE, Mangu, PB, Bartlett, JMS, Hanna, W, Bilous, M, Ellis, IO, Dowsett, M, Jenkins, RB, Spears, PA, Vance, GH & Viale, G 2018, 'Human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update', Archives of Pathology and Laboratory Medicine, vol. 142, no. 11, pp. 1364-1382. https://doi.org/10.5858/arpa.2018-0902-SA
Wolff, Antonio C. ; McShane, Lisa M. ; Hammond, M. Elizabeth Hale ; Allison, Kimberly H. ; Fitzgibbons, Patrick ; Press, Michael F. ; Harvey, Brittany E. ; Mangu, Pamela B. ; Bartlett, John M.S. ; Hanna, Wedad ; Bilous, Michael ; Ellis, Ian O. ; Dowsett, Mitchell ; Jenkins, Robert Brian ; Spears, Patricia A. ; Vance, Gail H. ; Viale, Giuseppe. / Human epidermal growth factor receptor 2 testing in breast cancer : American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. In: Archives of Pathology and Laboratory Medicine. 2018 ; Vol. 142, No. 11. pp. 1364-1382.
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abstract = "Purpose. - To update key recommendations of the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) human epidermal growth factor receptor 2 (HER2) testing in breast cancer guideline. Methods. - Based on the signals approach, an Expert Panel reviewed published literature and research survey results on the observed frequency of less common in situ hybridization (ISH) patterns to update the recommendations. Recommendations. - Two recommendations addressed via correspondence in 2015 are included. First, immunohistochemistry (IHC) 2+ is defined as invasive breast cancer with weak to moderate complete membrane staining observed in >10{\%} of tumor cells. Second, if the initial HER2 test result in a core needle biopsy specimen of a primary breast cancer is negative, a new HER2 test may (not ''must'') be ordered on the excision specimen based on specific clinical criteria. The HER2 testing algorithm for breast cancer is updated to address the recommended workup for less common clinical scenarios (approximately 5{\%} of cases) observed when using a dual-probe ISH assay. These scenarios are described as ISH group 2 (HER2/ chromosome enumeration probe 17 [CEP17] ratio ≥2.0; average HER2 copy number <4.0 signals per cell), ISH group 3 (HER2/CEP17 ratio <2.0; average HER2 copy number ≥6.0 signals per cell), and ISH group 4 (HER2/ CEP17 ratio <2.0; average HER2 copy number ≥4.0 and <6.0 signals per cell). The diagnostic approach includes more rigorous interpretation criteria for ISH and requires concomitant IHC review for dual-probe ISH groups 2 to 4 to arrive at the most accurate HER2 status designation (positive or negative) based on combined interpretation of the ISH and IHC assays. The Expert Panel recommends that laboratories using single-probe ISH assays include concomitant IHC review as part of the interpretation of all single-probe ISH assay results.",
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