Lung cancer incidence and mortality in National Lung Screening Trial participants who underwent low-dose CT prevalence screening: a retrospective cohort analysis of a randomised, multicentre, diagnostic screening trial.
Lung cancer incidence and mortality in National Lung Screening Trial participants who underwent low-dose CT prevalence screening: a retrospective cohort analysis of a randomised, multicentre, diagnostic screening trial.
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DOI：
10.1016/s1470-2045(15)00621-x
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发表时间：
2016-05
期刊：
影响因子：
51.1
通讯作者：
Aberle, Denise R.
中科院分区：
文献类型：
--
作者：
Patz, Edward F., Jr.;Greco, Erin;Gatsonis, Constantine;Pinsky, Paul;Kramer, Barnett S.;Aberle, Denise R.
建议高危人群每年进行肺癌低剂量CT筛查，但是否有必要在所有符合条件的个人中进行年度低剂量CT检查还不确定。这项研究检测了国家肺部筛查试验(NLST)参与者中低剂量CT筛查阴性的肺癌发病率，以探索在一些低风险亚群中是否可以证明较低的筛查频率是合理的。我们对NLST的数据进行了回顾性队列分析，NLST是一项随机的多中心筛查试验，比较了三次年度低剂量CT评估和三次年度胸部X光检查，以早期发现高危、合格的个人(年龄55-74岁，至少有30包吸烟史，如果曾吸烟者，在过去15年内戒烟)，从2002年8月5日至2004年4月26日从美国医疗中心招募。参与者在最后一次年度筛查后接受了长达5年的跟踪调查。为了这项分析的目的，我们的队列包括所有接受过低剂量CT患病率(T0)筛查的NLST参与者。我们确定了肺癌的频率、分期、组织学、诊断研究年份和发病率，以及总体和肺癌特有的死亡率，以及肺癌是筛查的结果还是在阴性筛查的一年内被发现。我们还估计了如果没有对T0筛查阴性的参与者进行第一次年度(T1)筛查对死亡率的影响。NLST在ClinicalTrials.gov注册，编号NCT00047385。我们的队列包括26231名参与者，他们被分配到低剂量CT筛查组，他们接受了T0筛查。T0筛查阴性的19 066名参与者的肺癌发病率低于所有26 231名T0筛查参与者(371·88[95%CI 337·97-408·26]/10万人年比661·23[622·07-702·21])，肺癌相关死亡率也较低(185·82[95%CI 162·17-211·93]/10万人年vs 277·20[252·28-303·90])。在T0筛查阴性的参与者中，T1筛查肺癌的发病率为0.34%(18 121名筛查参与者中有62名筛查发现癌症)，而所有T0筛查参与者的T0筛查肺癌发病率为1.0%(26231名参与者中有267名)。我们估计，如果T0阴性组没有进行T1筛查，在试验过程中，T0阴性组至多有28名参与者死于肺癌(死亡率从每10万人年185·82[95%可信区间162·17-211·93]上升到212·14[186·80-239·96])。与所有接受过低剂量CT患病率筛查的参与者相比，低剂量CT筛查阴性的参与者的肺癌发病率和肺癌特异性死亡率较低。由于过度频繁的筛查有相关的危害，在CT流行率筛查阴性的参与者中，增加筛查之间的间隔可能是合理的。
Annual low-dose CT screening for lung cancer has been recommended for high-risk individuals, but the necessity of yearly low-dose CT in all eligible individuals is uncertain. This study examined rates of lung cancer in National Lung Screening Trial (NLST) participants who had a negative prevalence (initial) low-dose CT screen to explore whether less frequent screening could be justified in some lower-risk subpopulations. We did a retrospective cohort analysis of data from the NLST, a randomised, multicentre screening trial comparing three annual low-dose CT assessments with three annual chest radiographs for the early detection of lung cancer in high-risk, eligible individuals (aged 55–74 years with at least a 30 pack-year history of cigarette smoking, and, if a former smoker, had quit within the past 15 years), recruited from US medical centres between Aug 5, 2002, and April 26, 2004. Participants were followed up for up to 5 years after their last annual screen. For the purposes of this analysis, our cohort consisted of all NLST participants who had received a low-dose CT prevalence (T0) screen. We determined the frequency, stage, histology, study year of diagnosis, and incidence of lung cancer, as well as overall and lung cancer-specific mortality, and whether lung cancers were detected as a result of screening or within 1 year of a negative screen. We also estimated the effect on mortality if the first annual (T1) screen in participants with a negative T0 screen had not been done. The NLST is registered with ClinicalTrials.gov, number NCT00047385. Our cohort consisted of 26 231 participants assigned to the low-dose CT screening group who had undergone their T0 screen. The 19 066 participants with a negative T0 screen had a lower incidence of lung cancer than did all 26 231 T0-screened participants (371·88 [95% CI 337·97–408·26] per 100 000 person-years vs 661·23 [622·07–702·21]) and had lower lung cancer-related mortality (185·82 [95% CI 162·17–211·93] per 100 000 person-years vs 277·20 [252·28–303·90]). The yield of lung cancer at the T1 screen among participants with a negative T0 screen was 0·34% (62 screen-detected cancers out of 18 121 screened participants), compared with a yield at the T0 screen among all T0-screened participants of 1·0% (267 of 26 231). We estimated that if the T1 screen had not been done in the T0 negative group, at most, an additional 28 participants in the T0 negative group would have died from lung cancer (a rise in mortality from 185·82 [95% CI 162·17–211·93] per 100 000 person-years to 212·14 [186·80–239·96]) over the course of the trial. Participants with a negative low-dose CT prevalence screen had a lower incidence of lung cancer and lung cancer-specific mortality than did all participants who underwent a prevalence screen. Because overly frequent screening has associated harms, increasing the interval between screens in participants with a negative low-dose CT prevalence screen might be warranted.