Lung cancer is the leading cause of cancer-related death in the United States.\r\nHere, we evaluated the potential clinical utility of soluble human epidermal growth factor\r\nreceptor 2 (sHER2) for the risk assessment, screening, and diagnosis of non-small cell\r\nlung cancer (NSCLC) using an unmatched case-control study design. Serum sHER2\r\nconcentrations were measured by immunoassay in 244 primary NSCLC cases and\r\n218 healthy controls. Wilcoxon rank-sum tests, logistic regression models, and receiver\r\noperating characteristic plots were used to assess whether sHER2 is associated with lung\r\ncancer. Median serum sHER2 concentrations are higher in patients with adenocarcinoma\r\nthan squamous cell carcinoma regardless of gender, and sHER2 is a weak, independent\r\nbiomarker of adenocarcinoma, but not of squamous cell carcinoma, adjusted for age and\r\ngender. The age-adjusted relative risk (odds) of adenocarcinoma is 3.95 (95% CI: 1.22,\r\n12.81) and 7.93 (95% CI: 2.26, 27.82) greater for women and men with high sHER2\r\nconcentrations (=6.60 ng/mL) vs. low sHER2 concentrations (=1.85 ng/mL), respectively.\r\nWhen adjusted for each other, sHER2, age, and gender discern healthy controls from\r\npatients with primary adenocarcinomas of the lung with 85.9% accuracy. We conclude that\r\neven though serum sHER2 is not a strong, stand-alone discriminatory biomarker of\r\nadenocarcinoma, sHER2 may be a useful, independent covariate in multivariate risk\r\nassessment, screening, and diagnostic models of lung cancer.
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