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01-05-2021 | Fluorescence in Situ Hybridization | Preclinical study

HER2 testing in breast cancers: comparison of assays and interpretation using ASCO/CAP 2013 and 2018 guidelines

Authors: Lauren E. McLemore, Constance T. Albarracin, Stephen K. Gruschkus, Roland L. Bassett Jr, Yun Wu, Sagar Dhamne, Isaiah Yim, Kevin Lin, Isabelle Bedrosian, Nour Sneige, Hui Chen

Published in: Breast Cancer Research and Treatment | Issue 1/2021

Abstract

Purpose

HER2 overexpression and gene amplification are routinely tested by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH), respectively. In addition, HER2 mRNA expression is also tested by the Oncotype DX assay. Discordance between laboratories among the different assays remains a problem. To improve the routine HER2 reporting, the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) updated their guidelines in 2018. Our study will compare concordance of HER2 status by IHC and FISH using ASCO/CAP 2013 and 2018 guidelines with Oncotype DX.

Methods

We retrospectively reviewed 657 estrogen receptor positive primary breast cancer cases with available Oncotype DX tests between 2011 and 2018. Medical records were reviewed for HER2 results by IHC, FISH, and Oncotype DX. The HER2 results by different assays and between 2013 and 2018 guidelines were compared.

Results

Of the 657 cases, 280 were tested by IHC, FISH, and Oncotype DX. HER2-equivocal cases by IHC 2013 guidelines were all negative (67/67, 100%) by FISH 2018 guidelines and by Oncotype DX. HER2-equivocal cases by FISH 2013 guidelines were all negative (16/16, 100%) by FISH 2018 guidelines, while 15/16 (93.8%) negative and 1/16 (6.2%) equivocal by Oncotype DX. The HER2-equivocal and HER2-negative groups were similar in age, gender, histology, grade, and Ki67 score.

Conclusions

HER2 concordance was highest between Oncotype DX (99.6%) and FISH per 2018 guidelines. This suggests that the ASCO/CAP 2018 guidelines improved the accurate stratification of HER2-equivocal cases.

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Title: HER2 testing in breast cancers: comparison of assays and interpretation using ASCO/CAP 2013 and 2018 guidelines
Authors: Lauren E. McLemore
Constance T. Albarracin
Stephen K. Gruschkus
Roland L. Bassett Jr
Yun Wu
Sagar Dhamne
Isaiah Yim
Kevin Lin
Isabelle Bedrosian
Nour Sneige
Hui Chen
Publication date: 01-05-2021
Publisher: Springer US
Keywords: Fluorescence in Situ Hybridization
Breast Cancer
Breast Cancer
Published in: Breast Cancer Research and Treatment / Issue 1/2021
Print ISSN: 0167-6806
Electronic ISSN: 1573-7217
DOI: https://doi.org/10.1007/s10549-021-06208-5

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