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| |  SABCS: Pathologist Assessment of HER-2/neu Status Concordant With Automatic Image Analysis By Andrew Bowser SAN ANTONIO, TX -- December 12, 2002 -- An automated image analyser that can evaluate breast cancer tissue samples for tumour expression of the human epidermal receptor HER-2/neu agreed with the pathologist's assessment 93 percent of the time, in a recent blinded study. The same technique showed 100 percent agreement with pathologists' assessment in tumours graded as 0 or 1+ on HER-2/neu gene amplification evaluation. "Quantitative image analysis might improve the manual subjectivity and interobserver variability in interpretation of HER-2/neu, particularly in screening for negative specimens," said Shirin Hasan, clinical scientist with Applied Imaging Corp., Santa Clara, California, United States. Determining HER-2/neu expression has become an important part of the pathologic evaluation of invasive breast cancers. In women whose tumours overexpress this oncogene, use of the monoclonal antibody trastuzumab (Herceptin®) has been shown to increase survival. Immunohistochemistry can be used to detect HER-2/neu overexpression. In addition, fluorescence in situ hybridisation (FISH) can be used to detect HER-2/neu gene amplification. Pathologists score membrane staining on a scale of 0 (no staining) to 3+ (strong, uniform staining). However, higher scores are controversial because they are subject to interobserver variability and reproducibility issues, Hasan said during her presentation here December 11th at the 25th Annual San Antonio Breast Cancer Symposium. To test the accuracy of the automatic slide analyser, investigators analysed 56 cases of infiltrating breast carcinoma by three methods: standard immunohistochemistry (IHC); FISH; or IHC with image analysis using the automated system MDS™, which scans slides to produce high-resolution digital images, then analyses the image, evaluating staining intensity on a scale of 0 to 255. One of three pathologists scored the IHC cases, which were then analysed by the MDS™ system. Investigators performed FISH using the PathVysion™ kit (Vysis, Inc.) and determined the scores according to standard protocols. Pathologists graded 56 of the 32 cases as 0 or 1+ and agreed with all of the values generated by the instrument, Hasan said. For the 24 higher-expression cases of high HER-2/neu (graded 2+ or 3+), there was a seven percent discrepancy. Studies are ongoing. "This is a promising tool for evaluation of HER-2/neu status," Hasan said. "It acts as an aid to the pathologist."
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