| ObjectivePrimary bronchogenic carcinoma(Lung cancer)is the leading cause of cancer-related death in the world,and non-small cell lung cancer(NSCLC)accounts for 85%of lung cancer cases.Malignant pleural effusion(MPE)is a common complication in NSCLC patients and an independent factor for poor survival.Approximately 50%of patients with advanced NSCLC develop MPE.However,the low accuracy of biomarkers limits their clinical diagnostic value.Therefore,it is essential to search more accurate non-invasive biomarkers for the differential diagnosis of pleural effusion.This study was designed to explore the level of endothelial-cell-specific molecule-1(ESM-1)in pleural effusion,evaluate the difference expression in benign and NSCLC patients with MPE,and explore the diagnostic and prognostic value of ESM-1 in NSCLC patients with MPE by Receiver operating characteristic(ROC)curve and survival analysis.Patients and methods120 patients with pleural effusion admitted to Nanjing Chest Hospital from July 2011 to April 2013 were enrolled into the study.By cytologic or histologic diagnosis of pleural effusion,all the patients were divided into MPE(70 patients)or BPE group(50 patients).The ESM-1 concentration in pleural effusion was tested by enzyme-linked immunosorbent assay(ELISA)and CEA concentration was tested by thechemiLuminescence method.ROC curve was calculated to assess the diagnostic value of ESM-1.When combined testing of ESM-1 with CEA,the logistic regression was used to analysis the probability prediction value,and draw ROC curve.Survival curves were performed by Kaplan-Meier method and survival characteristics were compared by log-rank test.Univariable and multivariate Cox proportional hazards model were carried out to analysis the significance of ESM-llevel for overall survival(OS).Results(1)No significant differences were found between MPE and BPE groupsin the distribution of age and gender.The ESM-1 concentration in MPE from NSCLC patients was significantly higher than those in BPE(51.17± 4.51ng/ml vs.13.67±0.92ng/ml,p<0.001).CEA concentration in MPE from NSCLC patients was significantly higher than those in BPE(185.26±29.20ng/ml vs.4.02 ± 0.37ng/ml,p<0.001).(2)Based on the ROC curve,the diagnostic threshold of ESM-1for MPE was>19.58ng/ml with the area under the curve(AUC)was 0.884(95%CI 0.825-0.943).Using a cutoff point of 19.58ng/ml,ESM-1 had a sensitivity of 81.4%(57 of 70 patients),a specificity of 84.0%(42 of 50 patients),and an accuracy of 82.5%(99 of 120 patients).The diagnostic threshold of CEA for MPE was>8.52ng/ml with the area under the curve(AUC)was 0.863(95%CI 0.825-0.943).Using a cutoff point of 8.52 ng/ml,ESM-1 had a sensitivity of 68.6%(48 of 70 patients),a specificity of 96.0%(48 of 50 patients),and an accuracy of 80.0%(96 of 120 patients).(3)Combined testing of ESM-1 with CEAlevel can increase the diagnostic sensitivity,specifivity and accuracy for NSCLC patients with MPE(85.7%,96.0%,82.7%).(4)NSCLC patients with pleural fluid ESM-1concentration below 19.58 ng/ml had significant longer OS than those patients with higher concentration(22.09 months vs.11.49 months,p=0.003).Multivariate survival analysis showed that high MPE ESM-1 level was an independent prognostic factor(HR,1.007;p =0.039)for the OS of NSCLC patients.This study showed that ESM-1 level in pleural effusion could be a potential diagnostic and prognostic marker in NSCLC patients with MPE.Conclusion(1)MPE presents higher ESM-1 concentration in NSCLC patients with MPE.ESM-1 in pleural effusion could be a potential diagnostic marker for NSCLC related MPE patients.The combined testing of ESM-1 with CEA can increase the diagnosis value forNSCLC patients with MPE.(2)ESM-1 in pleural effusion could be a potential independent prognostic marker for NSCLC patients with MPE.The higher the concentration of ESM-1 in MPE,the shorter for OS of the NSCLC patients with MPE. |
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