Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update
- PMID: 29846122
- DOI: 10.1200/JCO.2018.77.8738
Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update
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. Find additional information at www.asco.org/breast-cancer-guidelines .
Comment in
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In Reply.Arch Pathol Lab Med. 2019 Apr;143(4):413-414. doi: 10.5858/arpa.2018-0906-LE. Epub 2019 Jan 3. Arch Pathol Lab Med. 2019. PMID: 30605367 No abstract available.
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Human Epidermal Growth Factor Receptor 2 Testing by Fluorescent In Situ Hybridization: Positive or Negative? American Society of Clinical Oncology/College of American Pathologists Guidelines 2007, 2013, and 2018.Arch Pathol Lab Med. 2019 Apr;143(4):412-413. doi: 10.5858/arpa.2018-0905-LE. Epub 2019 Jan 3. Arch Pathol Lab Med. 2019. PMID: 30605368 No abstract available.
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Implementation of the 2018 Human Epidermal Growth Factor Receptor 2 Guideline by American Society of Clinical Oncology/College of American Pathologists Will Reduce False-Positive Tests.Arch Pathol Lab Med. 2019 Apr;143(4):411-412. doi: 10.5858/arpa.2018-0904-LE. Epub 2019 Jan 3. Arch Pathol Lab Med. 2019. PMID: 30605369 No abstract available.
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Author's Reply: To the Letter to the Editor by Sorscher.J Natl Compr Canc Netw. 2021 Jun 30;19(6):xxiii. doi: 10.6004/jnccn.2021.7060. J Natl Compr Canc Netw. 2021. PMID: 34214970 No abstract available.
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Clinical Consequences of Altering the Definition of HER2-Positive Breast Cancer to Exclude Group 2, HER2-Negative Disease.J Natl Compr Canc Netw. 2021 Jun 30;19(6):xxii. doi: 10.6004/jnccn.2021.7053. J Natl Compr Canc Netw. 2021. PMID: 34214971 No abstract available.
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