Image analysis of HER2 immunohistochemical staining: Reproducibility and concordance with fluorescence in situ hybridization of a laboratory-validated scoring technique

Douglas M. Minot, Jesse Voss, Susan Rademacher, Toe Lwin, Jessica Orsulak, Bolette Caron, Rhett Ketterling, Aziza Nassar, Beiyun Chen, Amy Clayton

Research output: Contribution to journalArticle

20 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)270-276
Number of pages7
JournalAmerican journal of clinical pathology
Volume137
Issue number2
DOIs
StatePublished - Feb 1 2012

Keywords

  • Breast neoplasms
  • Fluorescence in situ hybridization
  • HER2
  • Herceptin
  • Immunohistochemistry
  • Targeted therapy
  • Trastuzumab

ASJC Scopus subject areas

  • Pathology and Forensic Medicine

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