Utility of Serum HER-۲/ neu in Prediction of Tissue HER-۲ /neu Status of Primary Breast Cancer

Background: The use of biomarkers has become increasingly important in the diagnosis and treatment of several malignancies, including breast cancer. Among the established biomarkers, receptor tyrosine-protein kinase erbB-۲ (HER-۲/ neu) has been found to be of a predictive and prognostic role in breast cancer patients. Method: ۹۴ patients with primary breast cancer were enrolled in our prospective study between ۲۰۱۶ and ۲۰۱۷. ۵ cc clot blood samples were taken for serum HER- ۲/neu testing at the time of diagnosis of breast cancer. The patients’ demographic data, tumor characteristics, including tumor size, tumor grade, presence of lymph node involvement, and stage, hormone receptor, and tissue HER-۲/neu status of the subjects were recorded following tumor removal. Results: All of the patients were female with the age range of ۲۷ to ۸۰ years (the mean of age was ۴۹.۶۶. ۳۶ patients (۳۸.۳%) had positive tissue HER-۲ results and ۵۸ (۶۱.۷%) had negative results. In those with high level serum HER-۲ ECD, ۲۸(۷۷.۷%) had positive tissue HER-۲ and ۸(۲۲.۲%) had negative results. Moreover, in the patients with low level serum HER-۲ ECD, ۸(۱۳.۷%) had positive tissue HER-۲ and ۵۰(۸۶.۲%) had negative results with the sensitivity of ۷۷.۷% and specificity of ۸۶.۲%. HER۲ ECD levels were highly concordant with tissue HER۲ status, with a P value of less than ۰.۰۰۱, which was considered to be statistically significant. Among different clinicopathologic variables, serum and tissue HER-۲/nu were significantly correlated with only tumor grade. Conclusion: A significantly increased release of HER۲ ECD levels may accurately predict tumor HER۲ status as detected with immunohistochemistry and/or in situ hybridizations studies.

Keywords:

Breast neoplasms , HER ۲ proto-oncogene protein , In situ hybridization