PMID- 31723206 OWN - NLM STAT- MEDLINE DCOM- 20201112 LR - 20210110 IS - 2045-2322 (Electronic) IS - 2045-2322 (Linking) VI - 9 IP - 1 DP - 2019 Nov 13 TI - Impact of the 2018 ASCO/CAP guidelines on HER2 fluorescence in situ hybridization interpretation in invasive breast cancers with immunohistochemically equivocal results. PG - 16726 LID - 10.1038/s41598-019-53003-w [doi] LID - 16726 AB - The American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) recently issued updated guidelines on human epidermal growth factor receptor 2 (HER2) testing by fluorescence in situ hybridization (FISH) in invasive breast cancers. In this study, we aimed to investigate the impact of the new recommendations on HER2 FISH interpretation in invasive breast cancers with immunohistochemically (IHC) equivocal results. 1810 breast cancer cases with IHC equivocal results were enrolled in this study between January 2012 and May 2019. Concomitant IHC was performed on the same tissue blocks detected by FISH testing. According to the 2018 guidelines, all the cases in ISH group 2 were categorized as HER2 negative; three of four cases in ISH group 3 were considered as HER2 positive, while the one scored IHC 1+ was reclassified as HER2 negative; Fifty-three previously ISH equivocal cases were redistributed into ten HER2-positive cases and forty-three HER2-negative cases. In conclusion, the utility of 2018 ASCO/CAP guidelines resulted in a slight decrease in HER2 positive rate, due to the reclassification of cases in ISH group 2 and group 4. The implementation of the new guidelines can reduce reflex FISH test and make the diagnosis of HER2 gene status more definitive. FAU - Wang, Bo AU - Wang B AD - Department of Pathology, the first affiliated hospital of Zhejiang University, Qingchun Road 79#, Hangzhou, China. FAU - Ding, Wei AU - Ding W AD - Department of Pathology, the first affiliated hospital of Zhejiang University, Qingchun Road 79#, Hangzhou, China. FAU - Sun, Ke AU - Sun K AD - Department of Pathology, the first affiliated hospital of Zhejiang University, Qingchun Road 79#, Hangzhou, China. FAU - Wang, Xiaoling AU - Wang X AD - Department of Pathology, the first affiliated hospital of Zhejiang University, Qingchun Road 79#, Hangzhou, China. FAU - Xu, Liming AU - Xu L AD - Department of Pathology, the first affiliated hospital of Zhejiang University, Qingchun Road 79#, Hangzhou, China. FAU - Teng, Xiaodong AU - Teng X AD - Department of Pathology, the first affiliated hospital of Zhejiang University, Qingchun Road 79#, Hangzhou, China. teng1102069@zju.edu.cn. LA - eng PT - Journal Article DEP - 20191113 PL - England TA - Sci Rep JT - Scientific reports JID - 101563288 RN - 0 (Receptors, Estrogen) RN - 0 (Receptors, Progesterone) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Breast Neoplasms/genetics/metabolism/*pathology MH - Carcinoma, Ductal, Breast/genetics/metabolism/*pathology MH - Carcinoma, Lobular/genetics/metabolism/*pathology MH - Female MH - Follow-Up Studies MH - Humans MH - Immunohistochemistry/*standards MH - In Situ Hybridization, Fluorescence/*standards MH - Middle Aged MH - Neoplasm Invasiveness MH - Practice Guidelines as Topic/*standards MH - Prognosis MH - Receptor, ErbB-2/genetics/*metabolism MH - Receptors, Estrogen/metabolism MH - Receptors, Progesterone/metabolism MH - Retrospective Studies MH - Societies, Medical PMC - PMC6854277 COIS- The authors declare no competing interests. EDAT- 2019/11/15 06:00 MHDA- 2020/11/13 06:00 PMCR- 2019/11/13 CRDT- 2019/11/15 06:00 PHST- 2019/08/22 00:00 [received] PHST- 2019/10/25 00:00 [accepted] PHST- 2019/11/15 06:00 [entrez] PHST- 2019/11/15 06:00 [pubmed] PHST- 2020/11/13 06:00 [medline] PHST- 2019/11/13 00:00 [pmc-release] AID - 10.1038/s41598-019-53003-w [pii] AID - 53003 [pii] AID - 10.1038/s41598-019-53003-w [doi] PST - epublish SO - Sci Rep. 2019 Nov 13;9(1):16726. doi: 10.1038/s41598-019-53003-w.