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Serologic concentrations of HER-2/neu in breast cancer patients with visceral metastases receiving trastuzumab therapy predict the clinical course.

The HER-2/ neu oncoprotein, a member of the epidermal growth factor receptor family, is overexpressed in 20–30% of breast cancer patients as a result of gene amplification (1)(2). Various methods have been used to quantify both HER-2/ neu gene amplification and its gene product. Those methods most clinically applicable include fluorescence in situ hybridization for gene amplification and immunohistochemistry or ELISAs for protein overexpression (3)(4). The amplification/overexpression of HER-2/ neu may have several clinical implications that indicate an aggressive form of breast cancer with a significantly shortened relapse-free interval (1)(2). Nevertheless, the independence of this factor remains uncertain, as does the predictive value of HER-2/ neu overexpression for therapeutic success (5).

Treatment with trastuzumab, a humanized monoclonal antibody that binds with high affinity to the extracellular domain of HER-2/ neu , is a promising therapy for metastatic breast cancers that overexpress HER-2/ neu protein. In experimental models of breast cancer, trastuzumab was active in vitro and in vivo (5)(6); in addition, the administration of trastuzumab in combination with chemotherapy showed an augmented antitumor effect (7)(8). The largest clinical study recruited 222 patients with HER-2/ neu -overexpressing metastatic breast cancer who had relapsed after one or two chemotherapy regimens (9). The overall response rate (complete response plus partial response), as determined by an independent Response Evaluation Committee, was 16%, with a 4% complete response and a 12% partial response rate. In 469 patients with HER-2/ neu -overexpressing metastatic breast cancer who had not been previously treated with chemotherapy, the combination of trastuzumab with chemotherapy was associated with a longer time to disease progression, a higher rate of objective response, a longer duration of response, a lower death rate after 1 year, longer survival, and a 20% reduction in the risk …