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Author Mi Ja Lee, M.D., Ph.D. and Ho Jong Jeon, M.D., Ph.D.
Place of duty Department of Pathology, College of Medicine, Chosun University, Gwangju, Korea
Title Evaluation of Her-2/neu in Breast Cancer: Comparison of Immunohistochemistry and Polymerase Chain Reaction
Publicationinfo Cancer Research and Treatment 2003 Apr; 035(02): 96-101.
Key_word Breast neoplasm, Her-2/neu, Immunohistochemistry, PCR
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Abstract Purpose: In breast cancer, Her-2/neu amplification/ overexpression predicts a poor clinical outcome, and enhanced survival benefits have been reported with Her-2/neu targeted therapy. Currently, there are several methods for assessing the amplification/overexpression of Her-2/neu, each having advantages and disadvantages. The aim of this work was to establish a reproducible, sensitive and specific method of testing for Her-2/neu, which could be used in diagnostic pathology laboratories.

Materials and Methods: We compared the immunohistochemistry (IHC) detection of Her-2/neu overexpression, with differential polymerase chain reaction (PCR) to assess the gene amplification of the Her-2/ neu, in 163 cases of invasive ductal carcinoma of the breast using paraffin-embedded tissue. In addition, assessment of the appropriate cut off points was established.

Results: The overexpression of the Her-2/neu was

detected in 39 (23.9%) cases, and its amplification in 37 (22.7%) cases. The methods were positive in 21.5% of cases and negative in 74.8%. There was a 96.3% concordance between the two methods. The sensitivity and specificity of IHC, compared with PCR, were 94.6 and 96.8%, respectively.

Conclusion: We conclude that the automation of PCR-based Her-2/neu testing approaches is expected to play an increasing role in the future of Her-2/neu testing. Also, we have demonstrated that IHC is a sensitive and specific method for assessing Her-2/neu stati in breast cancer, compared to PCR. The current study indicates that moderate, or strong, complete membrane staining in ¡Ã10% of tumor cells provides an appropriate cut off point compared with PCR. (Cancer Research and Treatment 2003;35:96⁣101)