Journal Article

Trainable Immunohistochemical HER2/neu Image Analysis: A Multisite Performance Study Using 260 Breast Tissue Specimens

Albitar, Maher, Heyman, Eugene R., Lynch, Kathleen A., Olson, Allen, Thompson, Jim, Cohen, Cynthia, Agersborg, Sally S., Barker, Edward A., Vanderbilt, Burton L., Lange, Holger, Siddiqui, Momin T., Nassar, Aziza, Zhou, Weidong

2011

Overview

Context .—Aperio Technologies, Inc (Vista, California) provides a new immunohistochemistry (IHC) HER2 Image Analysis (IA) system that allows tuning of the intensity thresholds of the HER2/ neu scoring scheme to adapt to the staining characteristics of different reagents. Objective .—To compare the trainable IHC HER2 IA system for different reagents to conventional manual microscopy (MM) in a multisite study. Design .—Two hundred sixty formalin-fixed, paraffin-embedded breast cancer specimens from 3 clinical sites were assayed: 180 specimens stained with Dako's HercepTest (Carpinteria, California), and 80 specimens stained with Ventana's PATHWAY HER-2/ neu (Tucson, California). At each site, 3 pathologists performed a blinded reading of the glass slides with the use of a light microscope. The glass slides were then scanned and after a wash-out period and randomization, the same pathologists outlined a representative set of tumor regions to be analyzed by IHC HER2 IA. Each of the methods, MM and IA, was evaluated separately and comparatively by using κ statistics of negative HER2/ neu scores (0, 1+) versus equivocal HER2/ neu scores (2+) versus positive HER2/ neu scores (3+) among the different pathologists. Results .— κ Values for IA and MM were obtained across all sites. MM: 0.565–0.864; IA: 0.895–0.947; MM versus IA: 0.683–0.892 for site 1; MM: 0.771–0.837; IA: 0.726–0.917; MM versus IA: 0.687–0.877 for site 2; MM: 0.463–0.674; IA: 0.864–0.918; MM versus IA: 0.497–0.626 for site 3. Conclusion .—Aperio's trainable IHC HER2 IA system shows substantial equivalence to MM for Dako's HercepTest and Ventana's PATHWAY HER-2/ neu at 3 clinical sites. Image analysis improved interpathologist agreement in the different clinical sites.

• Publisher: College of American Pathologists
• Subject: Automation / Breast cancer / Cloning / Equipment and supplies / FDA approval / Formaldehyde / Gene amplification / Image processing / Immunohistochemistry / Medical prognosis / Metastasis / Microscopy / Monoclonal antibodies / Proteins / Reagents / Reproducibility