Department of Thoracic Surgery, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai, China.
College of Clinical Medicine, Shanghai University of Medicine & Health Science, Shanghai, China.
BMC Cancer. 2020 Feb 10;20(1):106. doi: 10.1186/s12885-020-6524-1.
Solitary pulmonary nodules (SPNs) is a common radiographic finding and require further evaluation because of the possibility of lung cancer. This study aimed to determine the sensitivity and specificity of circulating tumour cells (CTCs) as a marker for the diagnosis of SPNs and the integration of CTCs, carcinoembryonic antigen (CEA) and imaging findings to improve the sensitivity and specificity of diagnosis in patients with SPNs suspected of being lung cancer.
For the serum biomarker assay, the concentration of CEA was measured by an automated electrochemiluminescence analyzer. CTCs were collected from 6 ml of blood by the SE i-FISH method, which detects the gene copy number in eight chromosomes and the tumour-associated antigen CK18.
With a threshold of 6 CTC units, the method showed a sensitivity of 67.1% and a specificity of 56.5% in the diagnosis of NSCLC, especially in the upper lobe, in which the diagnostic strength was the highest (P < 0.01). CTCs, CEA and nodule type had the highest diagnostic efficacy (area under the curve, 0.827; 95% confidence interval, 0.752-0.901) in patients with SPNs being suspected lung cancer. Combining CTCs (cut-off value 12 units) with CEA (1.78 ng/ml), the method showed a sensitivity of 77.8% and a specificity of 90% in the diagnosis of NSCLC, especially in the upper lobe, subsolid nodules and nodules ≥8 mm.
Our results demonstrated that CTCs are feasible diagnostic biomarkers in patients with SPNs, especially in the upper lobe. Furthermore, CTCs combined with CEA showed higher diagnostic efficacy in the upper lobe, subsolid nodules and nodules ≥8 mm.
孤立性肺结节（SPNs）是一种常见的影像学表现，由于存在肺癌的可能性，需要进一步评估。本研究旨在确定循环肿瘤细胞（CTCs）作为 SPNs 诊断标志物的敏感性和特异性，以及整合 CTCs、癌胚抗原（CEA）和影像学表现以提高疑似肺癌 SPNs 患者的诊断敏感性和特异性。
采用自动化电化学发光分析仪检测血清生物标志物，检测 CEA 浓度。采用 SE i-FISH 法从 6ml 血液中采集 CTCs，该方法检测 8 条染色体和肿瘤相关抗原 CK18 的基因拷贝数。
以 6CTC 单位为阈值，该方法在诊断 NSCLC 中的敏感性为 67.1%，特异性为 56.5%，尤其是在上叶，诊断强度最高（P<0.01）。在疑似肺癌的 SPNs 患者中，CTC、CEA 和结节类型具有最高的诊断效能（曲线下面积，0.827；95%置信区间，0.752-0.901）。将 CTC（截断值 12 单位）与 CEA（1.78ng/ml）结合，该方法在诊断 NSCLC 中的敏感性为 77.8%，特异性为 90%，尤其是在上叶、亚实性结节和结节≥8mm。
我们的结果表明，CTCs 是 SPNs 患者可行的诊断生物标志物，尤其是在上叶。此外，CTCs 联合 CEA 在上叶、亚实性结节和结节≥8mm 中具有更高的诊断效能。
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