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Significance of, and Optimal Screening for, HER-2 Gene Amplification and Protein Overexpression in Breast Carcinoma

Address correspondence to William K. Funkhouser, M.D., Ph.D., CB 7525, Department of Pathology and Laboratory Medicine, UNC School of Medicine, Chapel Hill, NC 27599-7525, USA; tel 919 966 7026; fax 919 966 6718; e-mail bill_funkhouser{at}med.unc.edu.

Breast carcinoma is a common disease, with an estimated 183,000 new cases expected in the USA during 2000. Whereas early stage patients have high likelihood of cure, only 20–40% of patients with metastatic breast carcinoma respond to presently available chemotherapy. A need exists to identify the underlying biological subsets of morphologically similar carcinomas in order to develop customized therapies for patients who require chemotherapy. The HER-2 receptor tyrosine kinase is overexpressed in 15–30% of breast carcinomas, and is associated with a worse prognosis stage-for-stage. Humanized monoclonal antibody therapy (Herceptin^TM; Genentech Co.) appears to benefit this subset of patients by improving their response rate and survival following anthracycline- or taxane-based chemotherapeutic regimens. Both HER-2 gene amplification and protein overexpression correlate with clinical outcomes, and screening for HER-2 gene amplification appears to be the more informative test. This article reviews data on the HER-2 gene and protein, discusses their association with clinical outcomes, and proposes a strategy for screening for HER-2 excess in formalin-fixed specimens of breast carcinoma.

Keywords: breast cancer, HER-2 gene amplification, HER-2 protein overexpression, cancer chemotherapy

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