PMID- 34559875 OWN - NLM STAT- MEDLINE DCOM- 20220531 LR - 20220630 IS - 1543-2165 (Electronic) IS - 0003-9985 (Linking) VI - 146 IP - 6 DP - 2022 Jun 1 TI - Clinical and Pathologic Features Associated With Invasive Breast Carcinoma With 2018 American Society of Clinical Oncology/College of American Pathologists In Situ Hybridization Group 2 Results (Human Epidermal Growth Factor Receptor 2 [HER2]/Chromosome 17 Centromere [CEP17] Ratio >/=2.0 and Average HER2 Copy Number <4.0). PG - 701-709 LID - 10.5858/arpa.2021-0155-OA [doi] AB - CONTEXT.-: The American Society of Clinical Oncology/College of American Pathologists updated the human epidermal growth factor receptor 2 (HER2) breast carcinoma testing guideline in 2018 to address issues from uncommon HER2 fluorescence in situ hybridization (FISH) results. Based on the 2013 American Society of Clinical Oncology/College of American Pathologists guideline, cases wherein the HER2/chromosome 17 centromere (CEP17) ratio of 2.0 or more with an average HER2 copy number of less than 4.0 were considered in situ hybridization (ISH) positive. Under the 2018 guideline, such cases are classified as ISH Group 2 and are no longer considered eligible for anti-HER2 therapy when the corresponding HER2 immunohistochemistry result is 0, 1+, or 2+. OBJECTIVE.-: To assess the clinical, pathologic, and treatment aspects of patients with ISH Group 2 results. DESIGN.-: We retrospectively reviewed HER2 FISH results at our center between January 2012 and December 2014 and identified and characterized cases with ISH Group 2 results. RESULTS.-: Thirty-nine cases with ISH Group 2 results from 39 patients were reviewed. Twenty of 39 (51%) patients received anti-HER2 therapy. Patients treated with HER2-targeted therapy were less likely to have hormone receptor-positive tumors, compared with patients without anti-HER2 treatment, though not significantly (P = .30). The only significant difference between the 2 patient groups was receipt of cytotoxic chemotherapy treatment (P < .001). Overall, clinical outcome was similar between the 2 groups (P > .99). CONCLUSIONS.-: This retrospective study with median follow-up of at least 6 years shows patients with ISH Group 2 tumors had similar clinical outcomes, irrespective of HER2-targeted therapy. Further analysis in the prospective setting would provide valuable data that would potentially inform clinical decision making. FAU - Hoda, Raza S AU - Hoda RS AD - From the Robert J Tomsich Pathology & Laboratory Medicine Institute (Hoda, McIntire, Sprague, Komforti, Downs-Kelly), Cleveland Clinic, Cleveland, Ohio. FAU - Zarei, Shabnam AU - Zarei S AD - From the Department of Pathology, University Hospitals Cleveland Medical Center/Case Western Reserve University, Cleveland, Ohio (Zarei). FAU - McIntire, Patrick J AU - McIntire PJ AD - From the Robert J Tomsich Pathology & Laboratory Medicine Institute (Hoda, McIntire, Sprague, Komforti, Downs-Kelly), Cleveland Clinic, Cleveland, Ohio. FAU - Sprague, Cathy AU - Sprague C AD - From the Robert J Tomsich Pathology & Laboratory Medicine Institute (Hoda, McIntire, Sprague, Komforti, Downs-Kelly), Cleveland Clinic, Cleveland, Ohio. FAU - Mekhail, Yasmin AU - Mekhail Y AD - From the Department of Diagnostic Radiology (Mekhail), Cleveland Clinic, Cleveland, Ohio. FAU - Carlson, Diane L AU - Carlson DL AD - From the Department of Pathology, Cleveland Clinic Florida, Weston, Florida (Carlson). FAU - Komforti, Miglena K AU - Komforti MK AD - From the Robert J Tomsich Pathology & Laboratory Medicine Institute (Hoda, McIntire, Sprague, Komforti, Downs-Kelly), Cleveland Clinic, Cleveland, Ohio. FAU - Downs-Kelly, Erinn P AU - Downs-Kelly EP AD - From the Robert J Tomsich Pathology & Laboratory Medicine Institute (Hoda, McIntire, Sprague, Komforti, Downs-Kelly), Cleveland Clinic, Cleveland, Ohio. 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 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Biomarkers, Tumor/metabolism MH - *Breast Neoplasms/pathology MH - Centromere/genetics MH - Chromosomes, Human, Pair 17/genetics MH - *DNA Copy Number Variations MH - Female MH - Humans MH - In Situ Hybridization, Fluorescence/methods MH - Medical Oncology MH - Pathologists MH - Prospective Studies MH - Receptor, ErbB-2/genetics/metabolism MH - Retrospective Studies EDAT- 2021/09/25 06:00 MHDA- 2022/06/01 06:00 CRDT- 2021/09/24 17:21 PHST- 2021/05/26 00:00 [accepted] PHST- 2021/09/25 06:00 [pubmed] PHST- 2022/06/01 06:00 [medline] PHST- 2021/09/24 17:21 [entrez] AID - 470823 [pii] AID - 10.5858/arpa.2021-0155-OA [doi] PST - ppublish SO - Arch Pathol Lab Med. 2022 Jun 1;146(6):701-709. doi: 10.5858/arpa.2021-0155-OA.