新型生物标志物组合对早期非小细胞肺癌检测的诊断意义：盲法临床研究结果

Diagnostic significance of the novel biomarker combination for early-stage non-small cell lung cancer detection: results of the blind clinical study.

作者信息

Tcherkassova Janneta, Klinski Evgueni, Tsurkan Sergey, Prostyakova Anna, Boroda Alexander, Pirogova Yuliya N, Bagmet Leonid N, Sekacheva Marina

机构信息

Research & Development Department, Universal Cancer Marker (UCM) Technologies, Toronto, ON, Canada.

Laboratory Polymers for Biology, Shemaykin-Ovchinnikov Institute of Bioorganic Chemistry RAS, Moscow, Russia.

出版信息

Front Oncol. 2025 May 19;15:1508563. doi: 10.3389/fonc.2025.1508563. eCollection 2025.

DOI:10.3389/fonc.2025.1508563

PMID:40458730

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12127355/

Abstract

BACKGROUND

NSCLC can be cured in up to 65% of cases if detected early. However, most of the lung cancer (LC) cases are diagnosed at an advanced stage.

OBJECTIVE

The assessment of various tumor markers in retrospective double-blind clinical study and their possible combinations for detection of early-staged non-small cell lung cancer (NSCLC); evaluation of the best TM panel as a pre-screening tool for LC before Low-Dose CT scan; the development of the protocol for future prospective clinical study.

METHODS

A double-blind clinical study was conducted on 304 clinically verified patients, including 141 NSCLC, 133 healthy volunteers and 30 patients with COPD. Quantitative measurement of various TM was carried out using commercial immunoassays.

RESULTS

Unlike other tumor markers, which are expressed proportionally to the tumor growth, CA-62 demonstrated the highest values at Stage I and II of NSCLC. The use of CA-62 for early-staged NSCLC achieves 92% sensitivity at 95% specificity (AUC = 0.973). The diagnostic value of the best TM signature (CA-62, CEA and CYFRA 21-1): 100% Specificity, 90% Sensitivity, and 94% test accuracy, AUC=0.990.

CONCLUSIONS

The results of the study demonstrated that the TM combination allows increasing the Specificity for patients with indeterminate pulmonary nodules detected by CT scans and improves the accuracy of differential diagnosis.

摘要

背景

如果早期发现，高达65%的非小细胞肺癌（NSCLC）病例可以治愈。然而，大多数肺癌（LC）病例在晚期才被诊断出来。

目的

在回顾性双盲临床研究中评估各种肿瘤标志物及其用于检测早期非小细胞肺癌（NSCLC）的可能组合；评估最佳肿瘤标志物组合作为低剂量CT扫描前肺癌预筛查工具的效果；制定未来前瞻性临床研究方案。

方法

对304例经临床验证的患者进行双盲临床研究，包括141例NSCLC患者、133例健康志愿者和30例慢性阻塞性肺疾病（COPD）患者。使用商业免疫测定法对各种肿瘤标志物进行定量测量。

结果

与其他与肿瘤生长成比例表达的肿瘤标志物不同，CA-62在NSCLC的I期和II期显示出最高值。使用CA-62检测早期NSCLC，在特异性为95%时灵敏度达到92%（曲线下面积[AUC]=0.973）。最佳肿瘤标志物组合（CA-62、癌胚抗原[CEA]和细胞角蛋白19片段[CYFRA 21-1]）的诊断价值：特异性为100%，灵敏度为90%，检测准确率为94%，AUC=0.990。