PMID- 30230095 OWN - NLM STAT- MEDLINE DCOM- 20190815 LR - 20190815 IS - 1524-4741 (Electronic) IS - 1075-122X (Linking) VI - 24 IP - 6 DP - 2018 Nov TI - Comparing breast biomarker status between routine immunohistochemistry and FISH studies and Oncotype DX testing, a study of 610 cases. PG - 889-893 LID - 10.1111/tbj.13110 [doi] AB - INTRODUCTION: Oncotype DX (ODX) testing uses reverse transcription polymerase chain reaction (RT-PCR) to predict distant recurrence rate of estrogen receptor positive (ER+)/HER2-negative (HER2-)/lymph node-negative (LN-) breast cancers. ODX also reports the status of breast cancer biomarkers, ER, progesterone receptor (PR), and HER2. This study examined the discrepancy rate of breast cancer biomarker status as reported by ODX vs routinely used immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) methods. METHODS: A total of 610 breast cancer cases (609 ER+ and 1 ER-negative (ER-) by IHC) with ODX reports were reviewed. ER, PR, and HER2 status from ODX reports were compared with results from IHC and FISH studies. RESULTS: There was an overall high concordance rate between IHC and ODX for ER expression (603/610 concordant, 98.9%) and moderate concordance for PR expression (549/610 concordant, 90%). Of the seven ER-discrepant cases, six were positive by IHC but negative by ODX. Of the 61 PR-discrepant cases, 41 were positive by IHC but negative by ODX. Of the 610 cases, 568 had HER2 results reported by ODX. Five cases were HER2+ by IHC/FISH (0.88%). One of these five cases was reported as HER2+, two as HER2-, and two as HER2-equivocal by ODX. None of the cases that were HER2- or equivocal by IHC/FISH was reported as HER2+ by ODX. CONCLUSIONS: There is good concordance between IHC and ODX for ER and PR expression, but IHC is more sensitive. The significant discordance in HER2+ cases may discourage reporting HER2 status by ODX testing. CI - (c) 2018 Wiley Periodicals, Inc. FAU - Neely, Cameron AU - Neely C AD - Department of Pathology and Laboratory Medicine, Emory University, Atlanta, Georgia. FAU - You, Shuo AU - You S AD - Winship Cancer Institute, Emory University, Atlanta, Georgia. FAU - Mendoza, Pia M AU - Mendoza PM AD - Department of Pathology and Laboratory Medicine, Emory University, Atlanta, Georgia. FAU - Aneja, Ritu AU - Aneja R AD - Department of Biology, Georgia State University, Atlanta, Georgia. FAU - Sahin, Aysegul A AU - Sahin AA AD - Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Li, Xiaoxian AU - Li X AUID- ORCID: 0000-0002-0995-1721 AD - Department of Pathology and Laboratory Medicine, Emory University, Atlanta, Georgia. LA - eng PT - Comparative Study PT - Journal Article DEP - 20180919 PL - United States TA - Breast J JT - The breast journal JID - 9505539 RN - 0 (Biomarkers, Tumor) RN - 0 (Receptors, Estrogen) RN - 0 (Receptors, Progesterone) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) MH - Biomarkers, Tumor/*analysis/genetics MH - Breast Neoplasms/*genetics/*metabolism MH - Female MH - Gene Expression Regulation, Neoplastic MH - Humans MH - Immunohistochemistry/*methods MH - In Situ Hybridization, Fluorescence MH - Receptor, ErbB-2/genetics/metabolism MH - Receptors, Estrogen/genetics/metabolism MH - Receptors, Progesterone/genetics/metabolism MH - Reverse Transcriptase Polymerase Chain Reaction/*methods OTO - NOTNLM OT - Oncotype DX OT - biomarker OT - breast cancer OT - discordance OT - immunohistochemistry EDAT- 2018/09/20 06:00 MHDA- 2019/08/16 06:00 CRDT- 2018/09/20 06:00 PHST- 2017/09/06 00:00 [received] PHST- 2017/11/17 00:00 [revised] PHST- 2017/11/20 00:00 [accepted] PHST- 2018/09/20 06:00 [pubmed] PHST- 2019/08/16 06:00 [medline] PHST- 2018/09/20 06:00 [entrez] AID - 10.1111/tbj.13110 [doi] PST - ppublish SO - Breast J. 2018 Nov;24(6):889-893. doi: 10.1111/tbj.13110. Epub 2018 Sep 19.