PMID- 22914611 OWN - NLM STAT- MEDLINE DCOM- 20130926 LR - 20161020 IS - 1533-4058 (Electronic) IS - 1533-4058 (Linking) VI - 21 IP - 3 DP - 2013 May TI - Correlation between HER2 determined by fluorescence in situ hybridization and reverse transcription-polymerase chain reaction of the oncotype DX test. PG - 196-9 LID - 10.1097/PAI.0b013e3182632ff5 [doi] AB - The human epidermal growth factor receptor 2 (HER2) gene is amplified and its protein product overexpressed in about 20% of invasive breast cancers. Despite more than a decade of efforts to standardize HER2 testing, controversy persists regarding the most optimal testing method. Recently, Oncotype DX reports have begun including HER2 results in addition to the previously reported Recurrence Score. We compared HER2 results obtained by fluorescence in situ hybridization (FISH) in our laboratories with HER2 results obtained by reverse transcription-polymerase chain reaction (RT-PCR) as documented in the Oncotype DX report. We then sought to identify potentially significant characteristics in the discrepant cases. We identified breast cancer patients with estrogen receptor-positive, lymph node-negative tumors who had Oncotype DX testing performed between September 2008 and March 2012. Patient and tumor characteristics including HER2 FISH and Oncotype DX test results were recorded. Image analysis was performed on cases with discrepancy between the HER2 FISH and Oncotype DX HER2 results to determine the relative proportion of invasive tumor. Eight of 194 (4.1%) cases showed discrepancy between HER2 FISH and Oncotype DX RT-PCR results. Although the overall percent agreement (96%) and percent negative agreement (100%) were high, percent positive agreement was only 50%. Three of 8 (38%) discrepant cases showed heterogeneous amplification by FISH. Seven of 8 (88%) discrepant cases had <50% invasive tumor in the Oncotype DX tissue block. Percent positive agreement between HER2 FISH and Oncotype DX RT-PCR is low. Multiple factors may contribute to this discrepancy including a suboptimal microdissection and possibly heterogeneous amplification of HER2 gene in some cases. FAU - Dvorak, Leah AU - Dvorak L AD - University of Minnesota, Fairview, MN, USA. FAU - Dolan, Michelle AU - Dolan M FAU - Fink, James AU - Fink J FAU - Varghese, Linda AU - Varghese L FAU - Henriksen, Jonathan AU - Henriksen J FAU - Gulbahce, H Evin AU - Gulbahce HE LA - eng PT - Journal Article PL - United States TA - Appl Immunohistochem Mol Morphol JT - Applied immunohistochemistry & molecular morphology : AIMM JID - 100888796 RN - 0 (Biomarkers, Tumor) RN - 0 (Receptors, Estrogen) 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/*genetics MH - Breast Neoplasms/diagnosis/*genetics/*pathology MH - Carcinoma/diagnosis/*genetics/*pathology MH - Female MH - Genotyping Techniques MH - Humans MH - In Situ Hybridization, Fluorescence/standards MH - Lymph Nodes/pathology MH - Middle Aged MH - Neoplasm Invasiveness MH - Receptor, ErbB-2/*genetics MH - Receptors, Estrogen/genetics MH - Reverse Transcriptase Polymerase Chain Reaction/standards EDAT- 2012/08/24 06:00 MHDA- 2013/09/27 06:00 CRDT- 2012/08/24 06:00 PHST- 2012/08/24 06:00 [entrez] PHST- 2012/08/24 06:00 [pubmed] PHST- 2013/09/27 06:00 [medline] AID - 10.1097/PAI.0b013e3182632ff5 [doi] PST - ppublish SO - Appl Immunohistochem Mol Morphol. 2013 May;21(3):196-9. doi: 10.1097/PAI.0b013e3182632ff5.