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. 2019 Jun 5;152(1):17-26.
doi: 10.1093/ajcp/aqz012.

Impact of the 2018 ASCO/CAP HER2 Guideline Focused Update

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Impact of the 2018 ASCO/CAP HER2 Guideline Focused Update

Adlin M Gordian-Arroyo et al. Am J Clin Pathol. .

Abstract

Objectives: The 2018 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) human epidermal growth factor receptor 2 (HER2) guideline focused update revises the HER2 scoring criteria. We evaluated the impact on HER2 rates in breast carcinoma diagnosed at our center.

Methods: In a retrospective series of breast core biopsies with invasive carcinoma diagnosed between 2014 and 2017 (n = 1,350), HER2 status was classified according to 2013 and 2018 ASCO/CAP guidelines and changes in HER2 status identified.

Results: The 2018 guidelines reclassified the HER2 status of 6% of patients. Most changed from HER2 equivocal status (equivocal by immunohistochemistry and fluorescence in situ hybridization under the 2013 guidelines) to HER2-negative status (2018 guidelines). The HER2-positive rate decreased by 0.4%.

Conclusions: The 2018 guidelines decrease the rate of HER2 equivocal and positive breast cancer and reduce repeat HER2 testing on excision specimens. Approximately 0.4% of patients will become newly ineligible for anti-HER2 therapy.

Keywords: ASCO/CAP HER2 guidelines; Breast cancer; HER2 FISH; HER2 IHC.

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