PMID- 33942843 OWN - NLM STAT- MEDLINE DCOM- 20211109 LR - 20211109 IS - 1943-7722 (Electronic) IS - 0002-9173 (Linking) VI - 156 IP - 5 DP - 2021 Oct 13 TI - Detailed Reanalysis of 500 Breast Cancers With Equivocal HER2 Immunohistochemistry and Borderline ERBB2 Fluorescence In Situ Hybridization Results. PG - 886-894 LID - 10.1093/ajcp/aqab042 [doi] AB - OBJECTIVES: We investigated the impact of our laboratory's reflex testing process for resolving ERBB2 (HER2) status on breast cancer samples that require additional workup after fluorescence in situ hybridization (FISH), per guideline recommendations published in 2018 by the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP). METHODS: In total, 500 breast cancer specimens with ERBB2 FISH results in groups 2 through 4 (all reported as immunohistochemistry [IHC] equivocal [2+] at external laboratories) were resubmitted for IHC testing in our laboratory. Per the ASCO/CAP guideline, FISH was rescored when internal IHC was also equivocal (2+), targeted to tumor areas demonstrating more intense IHC staining, if observed. RESULTS: Reflex IHC/FISH testing changed the final reported ERBB2 status in 185 of 500 (37.0%) samples. Result changes included discordant IHC (n = 4 score 0, n = 132 score 1+, and n = 16 score 3+) and discordant FISH (n = 33). Numerical differences in FISH scores were comparable for targeted vs nontargeted FISH rescoring (P = .086 for ERBB2 copy number; P = .49 for ERBB2 ratio). Two cases showed larger differences in FISH scores, suggesting heterogeneity. CONCLUSIONS: Retesting of breast cancer samples with equivocal IHC frequently changes IHC results, but targeted reanalysis of borderline FISH results rarely identifies significant differences in ERBB2 copy number or ratio. CI - (c) American Society for Clinical Pathology, 2021. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. FAU - Geiersbach, Katherine B AU - Geiersbach KB AUID- ORCID: 0000-0003-0424-7572 AD - Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA. FAU - Sill, Daniel R AU - Sill DR AD - Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA. FAU - Del Rosario, Kristina M AU - Del Rosario KM AD - Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA. FAU - Meyer, Reid G AU - Meyer RG AD - Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA. FAU - Spears, Grant M AU - Spears GM AD - Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA. FAU - Yuhas, Jason A AU - Yuhas JA AD - Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA. FAU - Sukov, William R AU - Sukov WR AD - Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA. FAU - Jenkins, Robert B AU - Jenkins RB AD - Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA. FAU - Ocal, Idris T AU - Ocal IT AD - Department of Laboratory Medicine and Pathology, Mayo Clinic, Scottsdale, AZ, USA. FAU - Mounajjed, Taofic AU - Mounajjed T AD - Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA. FAU - Chen, Beiyun AU - Chen B AD - Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, 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 (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/genetics/metabolism MH - Female MH - Humans MH - Immunohistochemistry/*methods MH - In Situ Hybridization, Fluorescence/*methods MH - Middle Aged MH - Receptor, ErbB-2/*analysis OTO - NOTNLM OT - Breast cancer OT - FISH OT - HER2 OT - Image analysis OT - Immunohistochemistry EDAT- 2021/05/05 06:00 MHDA- 2021/11/10 06:00 CRDT- 2021/05/04 08:45 PHST- 2021/05/05 06:00 [pubmed] PHST- 2021/11/10 06:00 [medline] PHST- 2021/05/04 08:45 [entrez] AID - 6263677 [pii] AID - 10.1093/ajcp/aqab042 [doi] PST - ppublish SO - Am J Clin Pathol. 2021 Oct 13;156(5):886-894. doi: 10.1093/ajcp/aqab042.