循环肿瘤细胞用于区分肺小结节良恶性病变的临床研究

Clinical study on the differentiation of benign and malignant pulmonary nodules by circulating tumor cells

目的:本研究旨在评估循环肿瘤细胞(CTC)用于区别肺小结节良恶性病变的准确性,评估循环肿瘤细胞(CTC)对于肺癌的诊断价值。方法:共招募189例可疑肺癌计划进行手术的患者,在术前1 d收集外周血,采用循环肿瘤细胞分离仪(ISET技术平台-CTCBIOPSY^(?)-A10系统)对患者外周血样本中的CTC水平进行评估,检测肺小结节良恶性病变患者外周血的CTC数量并比较它们之间的差异,同时根据收集得到的数据,绘制受试者工作特征曲线(ROC),分析CTC检测在肺部良恶性病变中的诊断效能。结果:肺小结节良恶性病变患者的外周血中的CTC的数量之间存在显著性差异(Z=-8.64,P<0.01),CTC检测对肺癌鉴别的曲线下面积(AUC)为0.798,95%置信区间(CI)为0.728~0.868,敏感度为69.6%,特异度为81.5%,诊断阈值为2.5个/5 mL外周血。结论:外周血中CTC的检测对肺部良恶性病变的鉴别具有较好的诊断价值,具备肺癌早期筛查和辅助诊断的应用潜力。

Objective:To evaluate the accuracy of circulating tumor cells(CTC) to differentiate malignant and benign pulmonary nodules lesions,and to evaluate the diagnostic performances of detecting CTC for lung cancer.Methods:A total of 189 patients with suspected lung cancer and planning to undergo surgery were recruited in this study.Peripheral blood were collected at the day before operation and the CTC levels of patient were quantified by the ISET(Isolation based on Size of Epithelial Tumor cells) platform-CTCBIOPSY^(?)-A10 CTC isolation.The difference of CTC in patients with benign and malignant pulmonary nodules was analyzed.The receiver operating characteristic curves(ROC)were drawn based on the collected data,and the diagnostic efficacy of CTC assay was analyzed in the benign and malignant lesions of lung.Results:The numbers of CTCs detected in peripheral blood were significantly higher in patients with lung cancer than those with benign lung disease(Z=-8.64,P<0.01).The area under curve(AUC) of CTCs in discriminating between benign lesions and lung cancer was 0.798(95%CI:0.728-0.868),sensitivity was 69.6%,specificity was 81.5%,the cut-off value was 2.5 CTCs per 5 mL peripheral blood.Conclusion:Detecting CTC in peripheral blood has moderately diagnostic value of discriminating between benign lesions and malignant lung nodules.This ISET CTC technique has great potential for early lung cancer screening and adjuvant diagnosis.