PMID- 21934215 OWN - NLM STAT- MEDLINE DCOM- 20120119 LR - 20191210 IS - 0974-5130 (Electronic) IS - 0377-4929 (Linking) VI - 54 IP - 3 DP - 2011 Jul-Sep TI - Assessment of HER2/Neu status by fluorescence in situ hybridization in immunohistochemistry-equivocal cases of invasive ductal carcinoma and aberrant signal patterns: a study at a tertiary cancer center. PG - 532-8 LID - 10.4103/0377-4929.85087 [doi] AB - INTRODUCTION: HER-2/neu status determines the eligibility for targeted therapy with trastuzumab in breast carcinoma. Evaluation for HER-2/neu protein expression by immunohistochemistry (IHC) and gene amplification by fluorescence in situ hybridization (FISH) has become the gold standard. AIMS: Since data on HER-2/neu assessment by IHC and FISH and studies regarding concordance between the results of the two techniques are limited, especially from India, we sought to study HER-2 gene amplification status by FISH in equivocal (2+) cases by IHC and also study aberrant signal patterns. SETTINGS AND DESIGN: Mastectomies and breast core biopsies, equivocal for HER-2/neu protein expression, were analyzed for HER-2 amplification by FISH. MATERIALS AND METHODS: IHC (DAKO) and FISH (PathVysion dual-probe system) tests were performed on 68 of 112 (after exclusion) 10% neutral buffered formalin (NBF)-fixed paraffin-embedded tissues and evaluated according to American Society of Clinical Oncology ASCO guidelines. STATISTICAL ANALYSIS USED: Chi-square (chi2) test and the two-tailed P value were applied using Graphpad Quickcels software, version 2006. RESULTS: It was found that 73.5% of the IHC 2+ patients were negative for HER-2/neu amplification, 25% were positive (ratios ranging from 2.3 to 5.6) and 1 patient was equivocal (2.2). Retesting FISH HER-2 equivocal case on another tumor block by IHC demonstrated HER-2 overexpression of protein 3+, thus resolving the equivocal status. Polysomy and HER-2 genetic heterogeneity were seen frequently. CONCLUSIONS: The findings reiterate that IHC HER-2 equivocal cases are a heterogeneous group and need FISH for further categorization. Low concurrence (25%) rate between both IHC and FISH results in the equivocal scenario can be attributed to tumors with polysomy 17 and HER-2/neu genetic heterogeneity. FAU - Murthy, Sudha S AU - Murthy SS AD - Department of Laboratory Medicine (Pathology and Molecular Diagnostics), Basavatarakam Indo-American Cancer Hospital and Research Institute, Hyderabad, India. sudha.s@induscancer.com FAU - Sandhya, D G AU - Sandhya DG FAU - Ahmed, Faiq AU - Ahmed F FAU - Goud, K Iravathy AU - Goud KI FAU - Dayal, Monal AU - Dayal M FAU - Suseela, K AU - Suseela K FAU - Rajappa, Senthil J AU - Rajappa SJ LA - eng PT - Comparative Study PT - Evaluation Study PT - Journal Article PL - India TA - Indian J Pathol Microbiol JT - Indian journal of pathology & microbiology JID - 7605904 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 - Aged, 80 and over MH - Biopsy MH - Breast/pathology MH - Breast Neoplasms/*diagnosis/pathology MH - Carcinoma, Ductal/*diagnosis/pathology MH - Female MH - Humans MH - Immunohistochemistry MH - In Situ Hybridization, Fluorescence/*methods MH - India MH - Mastectomy MH - Microscopy MH - Middle Aged MH - Pathology, Molecular/*methods MH - Receptor, ErbB-2/*genetics EDAT- 2011/09/22 06:00 MHDA- 2012/01/20 06:00 CRDT- 2011/09/22 06:00 PHST- 2011/09/22 06:00 [entrez] PHST- 2011/09/22 06:00 [pubmed] PHST- 2012/01/20 06:00 [medline] AID - IndianJPatholMicrobiol_2011_54_3_532_85087 [pii] AID - 10.4103/0377-4929.85087 [doi] PST - ppublish SO - Indian J Pathol Microbiol. 2011 Jul-Sep;54(3):532-8. doi: 10.4103/0377-4929.85087.