Association between clinical characteristics and the diagnostic accuracy of circulating single‐molecule amplification and resequencing technology on detection epidermal growth factor receptor mutation status in plasma of lung adenocarcinoma

Background Lung cancer is the leading cause of cancer‐related mortality in the world. Circulating single‐molecule amplification and resequencing technology ( cSMART ) can successfully detect epidermal growth factor receptor ( EGFR ) mutation in non‐small cell lung cancer ( NSCLC ). However, few studies have investigated the association between clinical characteristics and the diagnostic accuracy of cSMART technique in lung adenocarcinoma. Methods We enrolled 95 patients, which included paraffin embedded tumor tissues and matched plasma samples. Retrospectively analyzed the correlation between clinical characteristics and sensitivity, specificity, accuracy, positive predictive value ( PPV ) and negative predictive value ( NPV ) of cSMART . Results Of the 95 lung adenocarcinoma cancer patients, 49 (51.5%) and 40 (42.1%) harbored EGFR mutations respectively in tissue and plasma. In younger than 60 years group, sensitivity, specificity and consistency for cSMART were 81.0%, 100%, and 90.9% ( P <.001). In metastasis group, sensitivity, specificity, and consistency for cSMART were 92.9%, 77.8%, and 87.0% ( P =.001). By univariate analysis, younger than 60 years ( OR =5.938; 95% confidence interval: 1.835‐19.210; P =.001); metastasis group ( OR =4.482; 95% confidence interval: 1.432‐14.024; P =.007) were significantly correlated with a higher accuracy. By multivariate analysis, younger than 60 years ( P =.003) and metastasis ( P =.004) were confirmed as independent factors for diagnostic accuracy of EGFR mutation in plasma through cSMART . Conclusion cSMART is feasible for detection EGFR mutation in plasma when tissue is unavailable. Age and metastasis might be considered as independent factors in diagnostic accuracy of cSMART in lung adenocarcinoma.