Elevated serum levels of a c-erbB-2 oncogene product in oral squamous cell carcinoma patients.

OBJECTIVES: Amplification of the proto-oncogene c-erbB-2 (HER-2/neu) has been shown to be a prognostic marker in many kinds of cancer including oral squamous cell carcinoma (OSCC). In order to obtain further information on the c-erbB-2 gene product p185, it is necessary to quantify expression levels. In this study we used an enzyme-linked immunosorbent assay (ELISA) for the extracellular domain of p185 to determine whether a soluble oncoprotein fragment can be detected in the serum of OSCC patients. METHOD: Sera from 84 OSCC patients, 51 breast cancer patients (as positive controls), and 15 healthy controls were assayed in an ELISA. To study c-erbB-2 overexpression in OSCC, and breast cancer tissue samples we used an immunohistochemical technique. RESULTS: The mean serum value (ng/ml, mean/SD) for the normal controls was 8.46/1.29. We chose the 95% level of normal controls as a cut-off to distinguish individuals with elevated levels. The breast cancer patients' and OSCC patients' serum values were 13.83/6.82 and 13.1/4.56, respectively. Significant differences (P < 0.0001) were observed between normal control and OSCC, normal control and the breast cancer group. Immunohistochemically detectable p185 (intermediate to high) was noted in 30 of 61 OSCC, and 24 of 51 breast cancer patients. There was a trend of association of serum oncoprotein fragment levels with tumor stages, but not with tumor sizes, nodal stages, metastases, and oral habits including betel quid chewing, alcohol drinking and smoking in the OSCC group. CONCLUSION: The results of the present study raise the possibility that soluble c-erbB-2 protein levels in serum is a useful parameter for monitoring the disease status as well as the effect of therapy on patients with OSCC.