In recent years investigators have looked at the human epidermal growth factor receptor-2 (HER2), which is overexpressed in 20%-30% of breast cancer patients, with regard to its role as a prognostic and predictive factor. Although many studies have suggested that HER2 overexpression may be associated with a poor clinical outcome, other studies have not fully supported this observation. The inconsistencies between studies may be due in part to discrepancies between different HER2 testing methods. To overcome this problem, a radioimmunohistochemical method was developed to quantitatively measure HER2 overexpression levels in breast tumor samples. The application of this method demonstrated that 85% of all breast tumor samples expressed HER2 at levels greater than normal. Of these, 23% expressed HER2 at levels between 45 and 480 times greater than normal, and this was associated with poor clinical outcome. The investigation of HER2 status as a predictor of response to therapy has also yielded many conflicting results. Overall, it appears that HER2 overexpression may correlate with resistance to hormonal therapy, sensitivity to anthracycline-based chemotherapy and resistance to CMF. With the development of targeted anti-HER2 therapies, assessment of HER2 status will be important in stratifying patients to the most appropriate treatment regimens.
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