PMID- 31966383 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20200126 IS - 1936-2625 (Electronic) IS - 1936-2625 (Linking) VI - 10 IP - 10 DP - 2017 TI - Concordance of immunohistochemistry and fluorescence in situ hybridization for assessment of HER2 status in breast cancer patients in Xinjiang autonomous region, China. PG - 10459-10466 AB - OBJECTIVE: To investigate the concordance rate between Immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) for assessment of HER2 status in breast cancer in Uighur ethnic minority and Han population in Xinjiang province, China. METHODS: Between January 2010 and June 2016, paraffin-embedded specimens form 1032 cases of breast cancer at the Tumor Hospital Affiliated to the Xinjiang Medical University were examined for HER2 status via both IHC and FISH using standard methodologies. The concordance between the two methods was then statistically evaluated. RESULTS: The IHC 0, 1+ and 3+ cases had a high concordance rate of 100%, 90.6% and 91.7%, respectively. The IHC 2+ had a low concordance rate (64.4%). 78.6% (293/373) HER2 positive specimens (2+ and 3+) showed HER2 gene amplification and 95.1% (627/659) HER negative cases (0 and 1+) were HER2 non-amplified, yielding a kappa score of 0.7581 (P < 0.0001). IHC negative 0 and FISH had a high concordance rate of 100% in both populations. Han and Uighur population had similar concordance rate between IHC (0, 1+ and 3+) and FISH (100% vs. 100%, 89.0% vs. 94.7% and 91.0% vs. 94.6%). Both populations had low concordance rate (63.1% vs. 71.0%) for IHC 2+ cases. HER2 status showed significant correlation with tumor size (P = 0.000). The Uighur minority had a lower HER2 amplification rate compared with Han population. CONCLUSION: IHC can be used as an initial screening test of HER2 status for both populations in Xinjiang province. However, for cases with a HER2 IHC 2+ result, a FISH test is required for confirmation. CI - IJCEP Copyright (c) 2017. FAU - Zhao, Bing AU - Zhao B AD - Oncology Day Unit, Tumor Hospital of Xinjiang Medical University Urumqi, Xinjiang, China. FAU - Wang, Yu AU - Wang Y AD - Department of Cadres Health Care, People's Hospital of Xinjiang Vygur Autonomous Region Urumqi, China. FAU - Xu, Hang AU - Xu H AD - Intensive Care Unit, The Sixth Affiliated Hospital, Xinjiang Medical University Urumqi, Xinjiang, China. LA - eng PT - Journal Article DEP - 20171001 PL - United States TA - Int J Clin Exp Pathol JT - International journal of clinical and experimental pathology JID - 101480565 PMC - PMC6965800 OTO - NOTNLM OT - Breast cancer OT - HER2 gene OT - anti-HER2 therapy OT - fluorescence in situ hybridization OT - immunohistochemistry COIS- None. EDAT- 2017/10/01 00:00 MHDA- 2017/10/01 00:01 PMCR- 2017/10/01 CRDT- 2020/01/23 06:00 PHST- 2017/06/11 00:00 [received] PHST- 2017/06/22 00:00 [accepted] PHST- 2020/01/23 06:00 [entrez] PHST- 2017/10/01 00:00 [pubmed] PHST- 2017/10/01 00:01 [medline] PHST- 2017/10/01 00:00 [pmc-release] PST - epublish SO - Int J Clin Exp Pathol. 2017 Oct 1;10(10):10459-10466. eCollection 2017.