Sullivan Francis Michael, Mair Frances S, Anderson William, Chew Cindy, Dorward Alistair, Haughney John, Hogarth Fiona, Kendrick Denise, Littleford Roberta, McConnachie Alex, McCowan Colin, McMeekin Nicola, Patel Manish, Rauchhaus Petra, Daly Fergus, Ritchie Lewis, Robertson John, Sarvesvaran Joseph, Sewell Herbert, Taylor Thomas, Treweek Shaun, Vedhara Kavita, Schembri Stuart
University of St Andrews, North Haugh, St Andrews, United Kingdom.
Institute of Health & Wellbeing, University of Glasgow, Glasgow, United Kingdom.
PLoS One. 2025 Jan 8;20(1):e0306163. doi: 10.1371/journal.pone.0306163. eCollection 2025.
The role of biomarkers in risk-based early detection of lung cancer may enable screening to become cost effective and widely accessible. EarlyCDT-Lung is an example of such a blood-based autoantibody biomarker which may improve accessibility to Low dose Computed Tomography (LDCT) screening for those at highest risk. We randomized 12 208 individuals aged 50-75 at high risk of developing lung cancer to either the test or to standard clinical care. Outcomes were ascertained from Register of Deaths and Cancer Registry. Cox proportional hazards models were used to estimate the hazard ratio of the rate of deaths from all causes and lung cancer. Additional analyses were performed for cases of lung cancer diagnosed within two years of the initial test. After 5 years 326 lung cancers were detected (2.7% of those enrolled). The total number of deaths reported from all causes in the intervention group was 344 compared to 388 in the control group. There were 73 lung cancer deaths in the intervention arm and 90 in the controls (Adjusted HR 0.789 (0.636, 0.978). An analysis of cases of lung cancer detected within 2 years of randomization in the intervention group showed that there were 34 deaths from all causes and 29 from lung cancer. In the control group there were 56 deaths with 49 from lung cancer. In those diagnosed with lung cancer within 2 years of randomization the hazard ratio for all cause mortality was 0.615 (0.401,0.942) and for lung cancer 0.598 (0.378, 0.946). Further large-scale studies of the role of biomarkers to target lung cancer screening, in addition to LDCT, are likely to provide additional value.
生物标志物在基于风险的肺癌早期检测中的作用可能使筛查具有成本效益并广泛可用。EarlyCDT-Lung就是这样一种基于血液的自身抗体生物标志物的例子，它可能会提高高危人群进行低剂量计算机断层扫描（LDCT）筛查的可及性。我们将12208名年龄在50 - 75岁、患肺癌风险高的个体随机分为检测组或接受标准临床护理组。通过死亡登记册和癌症登记处确定结果。使用Cox比例风险模型来估计全因死亡和肺癌死亡率的风险比。对初始检测后两年内诊断出的肺癌病例进行了额外分析。5年后，检测到326例肺癌（占入组者的2.7%）。干预组报告的全因死亡总数为344例，而对照组为388例。干预组有73例肺癌死亡，对照组有90例（调整后风险比0.789（0.636，0.978））。对干预组随机分组后2年内检测到的肺癌病例分析表明，全因死亡34例，肺癌死亡29例。对照组有56例死亡，其中49例死于肺癌。在随机分组后2年内被诊断为肺癌的患者中，全因死亡率的风险比为0.615（0.401，0.942），肺癌死亡率的风险比为0.598（0.378，0.946）。除了LDCT之外，进一步对生物标志物在肺癌筛查中的作用进行大规模研究可能会提供更多价值。
