Abstract
Objectives: In this study, we established a serum protein biomarker panel (consisting of Pro-SFTPB, CA125, Cyfra21-1, and CEA) and evaluated the feasibility and performance for the auxiliary diagnosis of lung cancer in the Chinese population. Materials and Methods: The current study was a single-center study based on the Chinese population and performed in two cohorts (training cohort and validation cohort). Serum concentrations of Pro-SFTPB, CA125, Cyfra21-1, and CEA were measured by a bead-based flow fluorescence immunoassay. The discrimination performance of the model was assessed using sensitivity, specificity, and the area under the receiver operating characteristic (ROC) curve (AUC). Results: For the biomarker panel model, the AUC was 0.88 (95% CI, 0.85-0.91) in the training cohort and 0.90 (95% CI, 0.86-0.92) in the validation data cohort, which was significantly greater than the AUC of each biomarker alone. For the nodule risk model, the AUC was improved to 0.96 (95% CI, 0.94-0.98) in the training cohort and 0.95 (95% CI, 0.93-0.97) in the validation cohort. In addition, the biomarker panel model yielded an AUC of 0.78 (95% CI, 0.74-0.81) for stage I & II lung cancer, better than the performance of individual biomarker alone. Conclusions: It was demonstrated that 4-protein biomarker panel had a significant performance in identifying lung cancer patients from healthy controls, especially combining with the nodule size. Specifically, it yielded excellent discrimination for identifying early-stage lung cancer patients than individual biomarker alone. A future large-scale study is underway to further define the clinical application of this method for the early diagnosis of lung cancer among Chinese populations.