Evaluation of sensitivity and specificity of CanPatrolTM technology for detection of circulating tumor cells in patients with non-small cell lung cancer

Abstract

Background The early diagnosis of non-small cell lung cancer is of great significance to the prognosis of patients. However, traditional histopathology and imaging screening have certain limitations. Therefore, new methods are urgently needed to make up for the current diagnostic defects.Objectives To evaluate of sensitivity and specificity of CanPatrol™ technology for detection of circulating tumor cells in patients with non-small cell lung cancer (NSCLC).Methods Non-interventional clinical research approach was used in this study. CTCs in the peripheral blood of 98 patients with NSCLC (including 48 patients in stage I, 13 in stage II, 29 in stage III and 8 in stage IV) and 38 patients with benign pulmonary diseases were collected by the latest typing of CanPatrol™ detection technology and nanomembrane filtration technology. CTCs were divided into epithelial, epithelial-mesenchymal, and mesenchymal types by multiple mRNA in situ analysis. We followed a 3-year follow-up of the 98 NSCLC patients to observe the recurrence and metastasis of the tumor. Next, Kruskal-Wallis test was used to compare multiple groups of data, Mann-Whitney U test was used to compare data between the two groups, and ROC curve analysis was used to obtain the critical value. Then, the COX risk regression and Kaplan-Meier survival analysis were performed in 63 NSCLC patients who were effectively followed up with recurrence and metastasis as the outcome.Results The epithelial, epithelial-mesenchymal and total CTCs were significantly higher in patients with NSCLC than in patients with benign lung disease (P < 0.001). The mesenchymal CTCs of NSCLC patients were slightly higher than those of benign lung diseases (P = 0.013). Both differences were statistically significant. The AUC of the ROC curve of the total CTCs was 0.837 (95% CI: 0.76–0.914), and the cut-off value corresponding to the most approximate index was 0.5 CTCs/5 ml, at which point the sensitivity was 81.6% and the specificity was 86.8%. COX regression analysis revealed that clinical stage was the factor affecting patient survival (P = 0.006), while gender, age and smoking were not statistically significant (P > 0.05). After excluding the confounders of staging, surgery, and chemotherapy, Kaplan-Meier survival analysis showed that patients in stage IIIA with CTCs ≥ 1 had significantly lower DFS than those with CTCs < 1 (P = 0.022).Conclusion CanPatrol™ technology has good sensitivity and specificity in detecting CTCs in peripheral blood of NSCLC patients, and has certain value for clinical prognosis evaluation.