PMID- 34124742 OWN - NLM STAT- MEDLINE DCOM- 20220106 LR - 20220106 IS - 1943-7722 (Electronic) IS - 0002-9173 (Linking) VI - 156 IP - 6 DP - 2021 Nov 8 TI - Reappraisal of HER2 Amplification in High-Grade Urothelial Carcinoma Based on 2018 ASCO/CAP Clinical Practice Guidelines. PG - 1130-1141 LID - 10.1093/ajcp/aqab083 [doi] AB - OBJECTIVES: To examine and compare human epidermal growth factor receptor 2 (HER2) amplification status in high-grade urothelial carcinoma (HGUCa), using both 2013 and 2018 HER2 reporting guidelines for breast carcinoma from the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP). METHODS: HER2 status by fluorescence in situ hybridization (FISH) assay in 78 cases of HGUCa was compared using 2013 and 2018 HER2 reporting guidelines. RESULTS: HER2 amplification was observed in 22 (28.2%) of 78 tumors, of which 17 were in group 1, 1 in group 2, and 2 each in groups 3 and 4 (FISH assay, 2018). The remaining 14 HER2-amplified tumors (FISH assay, 2013) became negative, falling into group 2 (FISH assay, 2018) and were either negative or equivocal on immunohistochemistry (IHC, 2018). All FISH-negative tumors (n = 37) using 2013 criteria remained negative (group 5, 2018). FISH-equivocal tumors (2013) were further categorized into HER2 amplified (n = 1) and HER2 negative (n = 4) (2018). Overall, 20 (25.6%) tumors had discordant HER2 FISH results (2018 vs 2013). CONCLUSIONS: Implementing 2018 guidelines, HER2 amplification decreased from 36 to 22 cases. The group with a HER2/CEP17 ratio of 2 or more and average HER2 copy number less than 4 (group 2) were predominantly negative by IHC, suggesting a biologically distinct group of HGUCa that is different from HER2-amplified tumors, which may not respond to HER2-targeted therapy. CI - (c) American Society for Clinical Pathology, 2021. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. FAU - Mohanty, Sambit K AU - Mohanty SK AD - Department of Pathology and Laboratory Medicine, Advanced Medical Research Institute, Bhubaneswar, India. AD - Department of Pathology and Laboratory Medicine, CORE Diagnostics, Gurgaon, India. FAU - Mishra, Sourav K AU - Mishra SK AD - Department of Medical Oncology, Advanced Medical Research Institute, Bhubaneswar, India. FAU - Tiwari, Ankit AU - Tiwari A AD - Department of Pathology and Laboratory Medicine, Advanced Medical Research Institute, Bhubaneswar, India. FAU - Sharma, Shivani AU - Sharma S AD - Department of Pathology and Laboratory Medicine, CORE Diagnostics, Gurgaon, India. FAU - Bhardwaj, Mohit AU - Bhardwaj M AD - Department of Pathology and Laboratory Medicine, CORE Diagnostics, Gurgaon, India. FAU - Pattnaik, Niharika AU - Pattnaik N AD - Department of Pathology and Laboratory Medicine, Advanced Medical Research Institute, Bhubaneswar, India. FAU - Jaiswal, Sunil AU - Jaiswal S AD - Department of Surgical Oncology, Advanced Medical Research Institute, Bhubaneswar, India. FAU - Baisakh, Manas R AU - Baisakh MR AD - Department of Pathology and Laboratory Medicine, Prolife Diagnostics, Bhubaneswar, India. FAU - Das, Subodh AU - Das S AD - Department of Urology, Advanced Medical Research Institute, Bhubaneswar, India. FAU - Pradhan, Manas R AU - Pradhan MR AD - Department of Urology, Advanced Medical Research Institute, Bhubaneswar, India. FAU - Swain, Tapas R AU - Swain TR AD - Department of Pathology and Laboratory Medicine, Advanced Medical Research Institute, Bhubaneswar, India. FAU - Satpathy, Kaliprasad AU - Satpathy K AD - Department of Urology, Kalinga Hospital, Bhubaneswar, India. FAU - Williamson, Sean R AU - Williamson SR AUID- ORCID: 0000-0002-3898-1460 AD - Department of Pathology, Cleveland Clinic , Cleveland, OH, USA. FAU - Parwani, Anil V AU - Parwani AV AD - Department of Pathology, Wexner Medical Center, Ohio State University, Columbus, OH, USA. LA - eng PT - Journal Article PL - England TA - Am J Clin Pathol JT - American journal of clinical pathology JID - 0370470 RN - 0 (Biomarkers, Tumor) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Biomarkers, Tumor/genetics MH - Breast Neoplasms MH - *Carcinoma, Transitional Cell MH - Female MH - Humans MH - Immunohistochemistry MH - In Situ Hybridization, Fluorescence MH - Practice Guidelines as Topic MH - Receptor, ErbB-2/genetics MH - *Urinary Bladder Neoplasms OTO - NOTNLM OT - ASCO/CAP practice guidelines OT - FISH OT - HER2 OT - High-grade bladder cancer EDAT- 2021/06/15 06:00 MHDA- 2022/01/07 06:00 CRDT- 2021/06/14 10:00 PHST- 2021/06/15 06:00 [pubmed] PHST- 2022/01/07 06:00 [medline] PHST- 2021/06/14 10:00 [entrez] AID - 6298214 [pii] AID - 10.1093/ajcp/aqab083 [doi] PST - ppublish SO - Am J Clin Pathol. 2021 Nov 8;156(6):1130-1141. doi: 10.1093/ajcp/aqab083.