The use of soluble salivary c-erbB-2 to detect breast cancer in women: a five year study.

C Streckfus DDS, L Bigler PhD, L Copeland DMD.

Office of Research, University of Mississippi Medical Center, Jackson, MS.

AIM: Carcinoma of the breast afflicts 1 in every ten women. Although mammography has reduced overall mortality and morbidity rates, there is still a need for adjunct diagnostic methodologies to reduce the number of false positives and negatives present in breast cancer detection. The purpose of this five-year study was to test the utility of salivary c-erbB-2 as a marker for the detection of breast cancer. METHODS: Subjects were classified into three groups of individuals. Individuals that were healthy, benign and with breast cancer. The subjects diagnosed with breast cancer were followed for five years while undergoing treatment. ELISA was used to assay the salivary and serum specimens. RESULTS: The five-year study revealed a soluble salivary form of the c-erbB-2 protein, which is found in the saliva of both healthy and diseased individuals. However, among cancer patients, the c-erbB-2 concentration is markedly elevated and correlates to serum concentrations (r=0.51; p<0.0001). The sensitivity of the test is 0.87 with a specificity of 0.65. These figures are higher than the FDA approved prostate specific antigen that is currently used to screen for carcinoma of the prostate. Additionally, the investigators have five years of longitudinal data to demonstrate the use of this marker for post-operative follow-up. Conclusions: The results of the study suggest that c-erbB-2 has the potential for use in initial detection and/or follow-up screening for the detection of breast cancer in women. These data also demonstrates that salivary c-erbB-2 can be used to monitor patients on a variety of treatment regimens.

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Paper presented at the International Symposium on Predictive Oncology and Intervention Strategies; Paris, France; February 9 - 12, 2002; in the section on Molecular Pathology.