Image Analysis of HER2 Immunohistochemical Staining Reproducibility and Concordance With Fluorescence In Situ Hybridization of a Laboratory-Validated Scoring Technique

Dept. of Laboratory Medicine and Pathology, Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA.
American Journal of Clinical Pathology (Impact Factor: 2.51). 02/2012; 137(2):270-6. DOI: 10.1309/AJCP9MKNLHQNK2ZX
Source: PubMed


Image analysis of the HER2 immunohistochemical (IHC) stain can help determine which breast cancer patients may benefit from HER2-targeted therapy. We studied the concordance of HER2 IHC and fluorescence in situ hybridization (FISH) as well as reproducibility of surgical pathologist (SP) and cytotechnologist (CT) interpretations using manual and image analysis methodologies on 154 IHC cases. Concordances with FISH were good for IHC negative (0, 1+) cases (range, 97%-100%) and positive (3+) cases (range, 87%-100%). Image analysis had fewer equivocal (2+) results (10.4%) than CT (14.9%) and SP (16.2%) manual methods, with higher concordances to FISH (31%, 26%, and 20% for image analysis, CT manual, and SP manual, respectively). CT manual (κ = 0.747) and image analysis (κ = 0.779) methods had better interobserver reproducibility than SP manual (κ = 0.697). CT image analysis had better intraobserver reproducibility (κ = 0.882) than CT (κ = 0.828) and SP (κ = 0.766) manual methods. HER2 IHC analysis performed by image analysis can produce accurate results with improved reproducibility.

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Available from: Aziza Nassar, Aug 21, 2014
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    • "The levels of serum HER2 as well as tumor tissue HER2 have been detected to be increased in the patients with breast cancer [33]. In clinical practice,immunohistochemistry (IHC) and fluorescence in situ hybridisation (FISH) are the suggested methods to determine HER2 status in cancer specimens [33, 34]. Currently, FDA has approved several kits or assays of IHC or FISH to determine HER2 expression. "
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