PMID- 35687792 OWN - NLM STAT- MEDLINE DCOM- 20220614 LR - 20220630 IS - 1543-2165 (Electronic) IS - 0003-9985 (Linking) VI - 146 IP - 5 DP - 2022 Jun 10 TI - Characteristics of HER2 Gene Amplification by Fluorescence In Situ Hybridization in Endometrial Serous Carcinoma. PG - 0 LID - 10.5858/arpa.2021-0547-OA [doi] AB - CONTEXT.-: Targeted anti-human epidermal growth factor receptor 2 (HER2) therapy has recently become the standard for advanced-stage and recurrent HER2-positive endometrial serous carcinoma (ESC) in the United States, and an endometrial carcinoma-specific HER2 testing algorithm has been proposed. However, comprehensive studies on the specific features of HER2 gene amplification in these tumors are lacking. OBJECTIVE.-: To evaluate the characteristics of HER2 amplification in ESC in the context of breast and gastric HER2 fluorescence in situ hybridization (FISH) guidelines. DESIGN.-: Ninety-four ESCs with available HER2 immunohistochemistry (IHC) and FISH were included. HER2 IHC was scored according to the proposed endometrial carcinoma-specific algorithm and FISH was evaluated by using the 2018 ESC clinical trial criteria, the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) 2016 gastric criteria, and ASCO/CAP 2013 and 2018 breast criteria. RESULTS.-: Most tumors (90.4%; 85 of 94) had a 2+ HER2 IHC score. Polysomy of chromosome 17 was present in 16% (15 of 94) and monosomy 17 was seen in 2% (2 of 94) of tumors. HER2 FISH interpretation per the clinical trial criteria (HER2/CEP17 ratio >/= 2.0) showed 99% concordance with the current gastric and breast HER2 FISH interpretations. CONCLUSIONS.-: Our results support the clinical trial criteria for HER2 FISH in ESC with a modification to include HER2 IHC 2+ and HER2/CEP17 ratio less than 2.0 and average HER2 copy number of 6.0 or greater in the HER2-positive category. Future prospective clinical investigations are necessary to assess the correlation between specific HER2 FISH result categories and therapeutic response. CI - (c) 2022 College of American Pathologists. FAU - Buza, Natalia AU - Buza N AD - From the Department of Pathology, Yale University, New Haven, Connecticut. FAU - Hui, Pei AU - Hui P AD - From the Department of Pathology, Yale University, New Haven, Connecticut. LA - eng PT - Journal Article PL - United States TA - Arch Pathol Lab Med JT - Archives of pathology & laboratory medicine JID - 7607091 RN - 0 (Biomarkers, Tumor) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Biomarkers, Tumor/genetics MH - *Breast Neoplasms/genetics MH - *Cystadenocarcinoma, Serous/genetics MH - *Endometrial Neoplasms/genetics MH - Female MH - Gene Amplification MH - Humans MH - In Situ Hybridization, Fluorescence/methods MH - Neoplasm Recurrence, Local MH - Receptor, ErbB-2/genetics/metabolism EDAT- 2022/06/11 06:00 MHDA- 2022/06/15 06:00 CRDT- 2022/06/10 15:13 PHST- 2022/01/13 00:00 [accepted] PHST- 2022/06/10 15:13 [entrez] PHST- 2022/06/11 06:00 [pubmed] PHST- 2022/06/15 06:00 [medline] AID - 482875 [pii] AID - 10.5858/arpa.2021-0547-OA [doi] PST - ppublish SO - Arch Pathol Lab Med. 2022 Jun 10;146(5):0. doi: 10.5858/arpa.2021-0547-OA.