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

Research output: Contribution to journalArticle

84 Citations (Scopus)

Abstract

Purpose To update key recommendations of the American Society of Clinical Oncology/College of American Pathologists 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 work-up 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)2105-2122
Number of pages18
JournalJournal of Clinical Oncology
Volume36
Issue number20
DOIs
StatePublished - Jul 10 2018

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

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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

In: Journal of Clinical Oncology, Vol. 36, No. 20, 10.07.2018, p. 2105-2122.

Research output: Contribution to journalArticle

Wolff, AC, Elizabeth Hale Hammond, M, Allison, KH, Harvey, BE, Mangu, PB, Bartlett, JMS, Bilous, M, Ellis, IO, Fitzgibbons, P, Hanna, W, Jenkins, RB, Press, MF, Spears, PA, Vance, GH, Viale, G, McShane, LM & Dowsett, M 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', Journal of Clinical Oncology, vol. 36, no. 20, pp. 2105-2122. https://doi.org/10.1200/JCO.2018.77.8738
Wolff, Antonio C. ; Elizabeth Hale Hammond, M. ; Allison, Kimberly H. ; Harvey, Brittany E. ; Mangu, Pamela B. ; Bartlett, John M.S. ; Bilous, Michael ; Ellis, Ian O. ; Fitzgibbons, Patrick ; Hanna, Wedad ; Jenkins, Robert Brian ; Press, Michael F. ; Spears, Patricia A. ; Vance, Gail H. ; Viale, Giuseppe ; McShane, Lisa M. ; Dowsett, Mitchell. / 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: Journal of Clinical Oncology. 2018 ; Vol. 36, No. 20. pp. 2105-2122.
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abstract = "Purpose To update key recommendations of the American Society of Clinical Oncology/College of American Pathologists 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 work-up 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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