PMID- 31213407 OWN - NLM STAT- MEDLINE DCOM- 20200811 LR - 20200811 IS - 1938-0666 (Electronic) IS - 1526-8209 (Linking) VI - 19 IP - 5 DP - 2019 Oct TI - The Impact of Partial Weak Staining in Normal Breast Epithelium on the Reliability of Immunohistochemistry Results in HercepTest-positive Breast Cancer. PG - 340-344 LID - S1526-8209(18)30847-4 [pii] LID - 10.1016/j.clbc.2019.04.017 [doi] AB - INTRODUCTION: Although normal epithelial cells do not show human epidermal growth factor receptor-2 (HER2) gene amplification and should lack membrane staining by HER2 immunohistochemistry (IHC), HER2 staining in benign breast epithelium is occasionally encountered. The significance of this occurrence has not yet been adequately studied, and its associated American Society of Clinical Oncology/College of American Pathologists recommendations are vague. Our objective is to assess the correlation between HER2 IHC 3+ breast cancer cases with normal epithelium staining (NES) and their corresponding fluorescence in situ hybridization (FISH) results, and to suggest recommendations for interpretation. MATERIALS AND METHODS: A total of 154 breast cancer cases with HER2 IHC 3+ were reviewed. NES, along with other clinicopathologic characteristics, were recorded. NES was scored as present or absent. All study cases were sent for FISH testing. All cases, and particularly those that showed false positivity for IHC (positive IHC, negative FISH) were examined for NES. RESULTS: Of the 154 cases, 146 cases were FISH-positive (94.8%) and 2 failed FISH testing (1.3%). Conversely, 22% (34/154) of the cases showed NES for HER2. Of these 34 cases, 23 (67%) were FISH-amplified, 9 (26%) were FISH not amplified, and 2 failed FISH testing. Notably, all of the false-positive (FISH-negative) breast cancer cases showed some degree of positivity in normal breast epithelium. CONCLUSIONS: Our findings, though descriptive, show a very strong association between NES and false-positive HER2 IHC. This confirms the need to carefully evaluate IHC-positive breast cancers for NES, and to have a low threshold for confirmatory testing by FISH. CI - Copyright (c) 2019 Elsevier Inc. All rights reserved. FAU - Farra, Chantal AU - Farra C AD - Department of Pathology and Laboratory Medicine, American University of Beirut Medical Center, Beirut, Lebanon. FAU - Fedda, Faysal AU - Fedda F AD - Department of Pathology and Laboratory Medicine, American University of Beirut Medical Center, Beirut, Lebanon. FAU - Tfayli, Arafat AU - Tfayli A AD - Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon. FAU - Tawil, Ayman AU - Tawil A AD - Department of Pathology and Laboratory Medicine, American University of Beirut Medical Center, Beirut, Lebanon. FAU - Zaatari, Ghazi AU - Zaatari G AD - Department of Pathology and Laboratory Medicine, American University of Beirut Medical Center, Beirut, Lebanon. FAU - Ashkar, Hanin AU - Ashkar H AD - Department of Pathology and Laboratory Medicine, American University of Beirut Medical Center, Beirut, Lebanon. FAU - Issa, Grece AU - Issa G AD - Department of Pathology and Laboratory Medicine, American University of Beirut Medical Center, Beirut, Lebanon. FAU - Boulos, Fouad AU - Boulos F AD - Department of Pathology and Laboratory Medicine, American University of Beirut Medical Center, Beirut, Lebanon. Electronic address: fb17@aub.edu.lb. LA - eng PT - Journal Article DEP - 20190518 PL - United States TA - Clin Breast Cancer JT - Clinical breast cancer JID - 100898731 RN - 0 (Biomarkers, Tumor) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM CIN - Clin Breast Cancer. 2020 Feb;20(1):87-88. PMID: 31732190 MH - Biomarkers, Tumor/*analysis MH - Breast/metabolism/*pathology MH - Breast Neoplasms/genetics/metabolism/*pathology MH - Female MH - Follow-Up Studies MH - Gene Amplification MH - Humans MH - Immunohistochemistry/*methods MH - In Situ Hybridization, Fluorescence/*methods MH - Middle Aged MH - Prognosis MH - Receptor, ErbB-2/*genetics/*metabolism OTO - NOTNLM OT - ASCO/CAP recommendations OT - False positive HER2 OT - Fluorescent in-situ hybridization OT - HER2 gene amplification OT - Normal breast epithelium EDAT- 2019/06/20 06:00 MHDA- 2020/08/12 06:00 CRDT- 2019/06/20 06:00 PHST- 2018/12/10 00:00 [received] PHST- 2019/04/24 00:00 [revised] PHST- 2019/04/28 00:00 [accepted] PHST- 2019/06/20 06:00 [pubmed] PHST- 2020/08/12 06:00 [medline] PHST- 2019/06/20 06:00 [entrez] AID - S1526-8209(18)30847-4 [pii] AID - 10.1016/j.clbc.2019.04.017 [doi] PST - ppublish SO - Clin Breast Cancer. 2019 Oct;19(5):340-344. doi: 10.1016/j.clbc.2019.04.017. Epub 2019 May 18.