The early detection of lung cancer (LC) improves patient outcomes, but current methods have limitations. Autoantibodies against tumor-associated antigens have potential as early biomarkers. This study evaluated the 9G testTMCancer/Lung, measuring circulating complexes of two antigen–autoantibody immune complexes (AIC) against their respective free antigens (CYFRA 21-1 and p53) for LC diagnosis. We analyzed 100 LC patients and 119 healthy controls using the 9G testTMCancer/Lung, quantifying the levels of AICs (CYFRA 21-1-Anti-CYFRA 21-1 autoantibody immune complex (CIC) and p53-Anti-p53 autoantibody immune complex (PIC)), free antigens (CYFRA 21-1 and p53), and ratios of AICs/antigens (LC index). The levels of the CICs and PICs were significantly elevated in LC compared to the controls (p< 0.0062 andp< 0.0026), while free antigens showed no significant difference. The CIC/CYFRA 21-1 and PIC/p53 ratios were also significantly higher in LC (all,p< 0.0001). The LC index, when combining both ratios, exhibited the best diagnostic performance with an area under the curve (AUC) of 0.945, exceeding individual CICs, PICs, and free antigens (AUCs ≤ 0.887). At a cut-off of 3.60, the LC index achieved 81% sensitivity and 95% specificity for LC diagnosis. It detected early-stage (Stage I–II) LC with 87.5% sensitivity, exceeding its performance in advanced stages (72.7%). The LC index showed no significant differences based on age, gender, smoking status (former, current, or never smoker), or pack years smoked. The LC index demonstrates promising potential for early LC diagnosis, exceeding conventional free antigen markers.
肺癌的早期检测可改善患者预后，但现有方法存在局限性。针对肿瘤相关抗原的自身抗体具有作为早期生物标志物的潜力。本研究评估了9G testTMCancer/Lung检测方法，通过测量两种抗原-自身抗体免疫复合物（CYFRA 21-1和p53）与其对应游离抗原的循环复合物水平进行肺癌诊断。我们采用该检测方法分析了100例肺癌患者和119例健康对照者，定量检测了免疫复合物（CYFRA 21-1-抗CYFRA 21-1自身抗体免疫复合物和p53-抗p53自身抗体免疫复合物）、游离抗原（CYFRA 21-1和p53）以及免疫复合物/抗原比值（LC指数）。结果显示，与对照组相比，肺癌患者的两种免疫复合物水平均显著升高（p<0.0062和p<0.0026），而游离抗原水平无显著差异。肺癌患者的CIC/CYFRA 21-1和PIC/p53比值也显著更高（均p<0.0001）。结合两种比值的LC指数展现出最佳诊断性能，曲线下面积达0.945，优于单独的免疫复合物和游离抗原检测（曲线下面积≤0.887）。当截断值为3.60时，LC指数对肺癌诊断的敏感度为81%，特异度为95%。该指数对早期（I-II期）肺癌的检测敏感度达87.5%，优于晚期肺癌的检测性能（72.7%）。LC指数在不同年龄、性别、吸烟状况（既往、当前或从未吸烟）及吸烟包年数分组中均未显示显著差异。研究表明，LC指数在早期肺癌诊断方面展现出超越传统游离抗原标志物的应用潜力。
肿瘤(癌症)患者之家