低剂量CT筛查降低肺癌死亡率：英国肺癌筛查试验随机试验结果及国际荟萃分析
Lung cancer mortality reduction by LDCT screening: UKLS randomised trial results and international meta-analysis.
作者信息
Field John K, Vulkan Daniel, Davies Michael P A, Baldwin David R, Brain Kate E, Devaraj Anand, Eisen Tim, Gosney John, Green Beverley A, Holemans John A, Kavanagh Terry, Kerr Keith M, Ledson Martin, Lifford Kate J, McRonald Fiona E, Nair Arjun, Page Richard D, Parmar Mahesh K B, Rassl Doris M, Rintoul Robert C, Screaton Nicholas J, Wald Nicholas J, Weller David, Whynes David K, Williamson Paula R, Yadegarfar Gasham, Gabe Rhian, Duffy Stephen W
机构信息
Department of Molecular and Clinical Cancer Medicine, Institute of Systems, Molecular and Integrative Biology, University of Liverpool, 6 West Derby Street, Liverpool L7 8TX, UK.
Centre for Prevention, Detection and Diagnosis, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
出版信息
Lancet Reg Health Eur. 2021 Sep 11;10:100179. doi: 10.1016/j.lanepe.2021.100179. eCollection 2021 Nov.
BACKGROUND
The NLST reported a significant 20% reduction in lung cancer mortality with three annual low-dose CT (LDCT) screens and the Dutch-Belgian NELSON trial indicates a similar reduction. We present the results of the UKLS trial.
METHODS
From October 2011 to February 2013, we randomly allocated 4 055 participants to either a single invitation to screening with LDCT or to no screening (usual care). Eligible participants (aged 50-75) had a risk score (LLPv2) ≥ 4.5% of developing lung cancer over five years. Data were collected on lung cancer cases to 31 December 2019 and deaths to 29 February 2020 through linkage to national registries. The primary outcome was mortality due to lung cancer. We included our results in a random-effects meta-analysis to provide a synthesis of the latest randomised trial evidence.
FINDINGS
1 987 participants in the intervention and 1 981 in the usual care arms were followed for a median of 7.3 years (IQR 7.1-7.6), 86 cancers were diagnosed in the LDCT arm and 75 in the control arm. 30 lung cancer deaths were reported in the screening arm, 46 in the control arm, (relative rate 0.65 [95% CI 0.41-1.02]; p=0.062). The meta-analysis indicated a significant reduction in lung cancer mortality with a pooled overall relative rate of 0.84 (95% CI 0.76-0.92) from nine eligible trials.
INTERPRETATION
The UKLS trial of single LDCT indicates a reduction of lung cancer death of similar magnitude to the NELSON and NLST trials and was included in a meta-analysis of nine randomised trials which provides unequivocal support for lung cancer screening in identified risk groups.
FUNDING
NIHR Health Technology Assessment programme; NIHR Policy Research programme; Roy Castle Lung Cancer Foundation.
背景
国家肺癌筛查试验（NLST）报告称，每年进行三次低剂量CT（LDCT）筛查可使肺癌死亡率显著降低20%，荷兰-比利时的NELSON试验也显示出类似的降低效果。我们公布了英国肺癌筛查试验（UKLS）的结果。
方法
2011年10月至2013年2月，我们将4055名参与者随机分为两组，一组接受单次LDCT筛查邀请，另一组不进行筛查（常规护理）。符合条件的参与者（年龄在50 - 75岁之间）的五年患肺癌风险评分（LLPv2）≥4.5%。通过与国家登记处的数据链接，收集截至2019年12月31日的肺癌病例数据以及截至2020年2月29日的死亡数据。主要结局是肺癌导致的死亡率。我们将我们的结果纳入随机效应荟萃分析，以综合最新的随机试验证据。
结果
干预组的1987名参与者和常规护理组的1981名参与者的中位随访时间为7.3年（四分位间距7.1 - 7.6），LDCT组诊断出86例癌症，对照组诊断出75例。筛查组报告了30例肺癌死亡，对照组报告了46例（相对率0.65 [95%可信区间0.41 - 1.02]；p = 0.062）。荟萃分析表明，九项符合条件的试验汇总后的总体相对率为0.84（95%可信区间0.76 - 0.92），肺癌死亡率显著降低。
解读
UKLS单次LDCT试验表明肺癌死亡降低幅度与NELSON和NLST试验相似，并被纳入九项随机试验的荟萃分析，该分析为在确定的风险人群中进行肺癌筛查提供了明确支持。
资助
英国国家卫生研究院卫生技术评估项目；英国国家卫生研究院政策研究项目；罗伊·卡斯尔肺癌基金会。
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