PMID- 32203091 OWN - NLM STAT- MEDLINE DCOM- 20210708 LR - 20230210 IS - 1530-0285 (Electronic) IS - 0893-3952 (Linking) VI - 33 IP - 8 DP - 2020 Aug TI - A clinicopathological study of 30 breast cancer cases with a HER2/CEP17 ratio of >/=2.0 but an average HER2 copy number of <4.0 signals per cell. PG - 1557-1562 LID - 10.1038/s41379-020-0519-y [doi] AB - The American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) have recently issued updated guidelines on human epidermal growth factor receptor 2 (HER2) testing by fluorescence in situ hybridization (FISH) in invasive breast cancers. Cases with a HER2/chromosome enumeration probe 17 (CEP17) ratio of >/=2.0 but an average HER2 copy number of <4.0 signals per cell (ISH group 2) are no longer automatically classified as ISH positive. Herein, 30 cases in ISH group 2 were collected. Another 100 patients with a HER2/CEP17 ratio <2.0 and <4.0 HER2 signals per cell (ISH group 5) and 100 patients with a HER2/CEP17 ratio of >/=2.0 and an average HER2 copy number of >/=4.0 signals per cell (ISH group 1) were also recruited for comparison. According to the 2018 ASCO/CAP guidelines, all the cases in ISH group 2 were categorized as HER2 negative. The clinicopathological characteristics of the patients in ISH group 2 were intermediate between ISH group 1 and group 5. Survival analyses revealed that there was no significant disease-free survival (DFS) and overall survival (OS) difference between patients with or without targeted therapy in ISH group 2, as well as between patients with targeted therapy in ISH group 1 and patients in ISH group 2. Patients without targeted therapy in ISH group 2 had a significantly worse OS than patients with targeted therapy in ISH group 1 and patients in ISH group 5. In conclusion, patients in ISH group 2 represent a biologically heterogeneous subset, which are different from those in ISH group 1 and 5. A larger cohort of patients in ISH group 2 should be included for future researches to define the efficacy of HER2-targeted therapy. FAU - Wang, Xiaoling AU - Wang X AD - Department of Pathology, the First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, China. FAU - Teng, Xiaodong AU - Teng X AD - Department of Pathology, the First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, China. FAU - Ding, Wei AU - Ding W AD - Department of Pathology, the First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, China. FAU - Sun, Ke AU - Sun K AD - Department of Pathology, the First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, China. FAU - Wang, Bo AU - Wang B AD - Department of Pathology, the First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, China. 1506128@zju.edu.cn. LA - eng PT - Journal Article DEP - 20200316 PL - United States TA - Mod Pathol JT - Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc JID - 8806605 RN - 0 (Biomarkers, Tumor) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Adult MH - Aged MH - Biomarkers, Tumor/*analysis MH - Breast Neoplasms/pathology MH - DNA Copy Number Variations MH - Female MH - Humans MH - In Situ Hybridization, Fluorescence MH - Middle Aged MH - Receptor, ErbB-2/*analysis EDAT- 2020/03/24 06:00 MHDA- 2021/07/09 06:00 CRDT- 2020/03/24 06:00 PHST- 2020/01/23 00:00 [received] PHST- 2020/02/27 00:00 [accepted] PHST- 2020/02/26 00:00 [revised] PHST- 2020/03/24 06:00 [pubmed] PHST- 2021/07/09 06:00 [medline] PHST- 2020/03/24 06:00 [entrez] AID - S0893-3952(22)00798-0 [pii] AID - 10.1038/s41379-020-0519-y [doi] PST - ppublish SO - Mod Pathol. 2020 Aug;33(8):1557-1562. doi: 10.1038/s41379-020-0519-y. Epub 2020 Mar 16.