Her2/neu Status Determination in Breast Cancer: A Single Institutional Experience Using a Dual-Testing Approach With Immunohistochemistry and Fluorescence In Situ Hybridization.

摘要: Objectives According to current guidelines, either immunohistochemistry (IHC) or in situ hybridization (ISH) can be used determine human epidermal growth factor receptor 2 (Her2/neu) status breast carcinoma. While the guidelines explicitly delineate result interpretation, there is no consensus on most appropriate testing algorithm. Methods The Her2/neu statuses of 369 consecutive cases invasive cancer (from 351 patients) were assessed a dual-testing algorithm that uses both IHC and fluorescence ISH (FISH). FISH was performed using dual-color HER2/ chromosome enumeration probe 17 ( CEP17 ) probes, if equivocal results obtained, reflex HER2/lissencephaly gene 1 LIS1 probes used. Results from modalities scored reported American Society Clinical Oncology/College Pathologists 2013 criteria. Sixty-one (16.5%) tumors found positive by at least one modality. overall concordance between 97.6%. Six reclassified as after negative result. also able identify significantly more Her2/neu-positive than IHC. Conclusions commonly strategy based may deny potentially beneficial targeted therapy for small cohort patients, which should considered are formulated cost-benefit analyses various algorithms assessed.