Patz Edward F, Greco Erin, Gatsonis Constantine, Pinsky Paul, Kramer Barnett S, Aberle Denise R
Department of Radiology, and Department of Pharmacology and Cancer Biology, Duke University Medical Center, Durham, NC, USA.
Center for Statistical Sciences, Brown University School of Public Health, Providence, RI, USA.
Lancet Oncol. 2016 May;17(5):590-9. doi: 10.1016/S1470-2045(15)00621-X. Epub 2016 Mar 18.
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.
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已建议对高危个体进行年度低剂量CT肺癌筛查,但对所有符合条件的个体每年进行低剂量CT筛查的必要性尚不确定。本研究调查了国家肺癌筛查试验(NLST)中初筛(首次)低剂量CT结果为阴性的参与者的肺癌发生率,以探讨在一些低风险亚组中减少筛查频率是否合理。
我们对NLST的数据进行了回顾性队列分析。NLST是一项随机、多中心筛查试验,比较了三年一次的低剂量CT评估与三年一次的胸部X光检查,用于在高危符合条件个体(年龄55 - 74岁,至少有30包年吸烟史,且如果是既往吸烟者,在过去15年内戒烟)中早期检测肺癌,这些个体于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随访长达5年。为了本次分析,我们的队列包括所有接受过低剂量CT初筛(T0)的NLST参与者。我们确定了肺癌的发生频率、分期、组织学类型、诊断研究年份、发病率,以及总体死亡率和肺癌特异性死亡率,以及肺癌是通过筛查发现还是在阴性筛查后1年内发现。我们还估计了如果对T0筛查为阴性的参与者未进行首次年度(T1)筛查对死亡率的影响。NLST已在ClinicalTrials.gov注册,编号为NCT00047385。
我们的队列包括26231名被分配到低剂量CT筛查组且已进行T0筛查的参与者。T0筛查为阴性的19066名参与者的肺癌发病率低于所有26231名接受T0筛查的参与者(每10万人年371.(95%CI 337.97 - 408.26) vs 661.23(622.07 - 702.21)),且肺癌相关死亡率也较低(每10万人年185.82(95%CI 162.17 - 211.93) vs 2(252.28 - 303.90))。T0筛查为阴性的参与者在T1筛查时肺癌的检出率为0.34%(18121名接受筛查的参与者中有62例通过筛查发现的癌症),而所有接受T0筛查的参与者在T0筛查时的检出率为1.0%(26231名中有267例)。我们估计,如果对T0阴性组未进行T1筛查,在试验过程中,T0阴性组最多再有28名参与者会死于肺癌(死亡率从每10万人年185.82(95%CI 162.17 - 211.93)上升至212.14(186.80 - 239.96))。
低剂量CT初筛为阴性的参与者的肺癌发病率和肺癌特异性死亡率低于所有接受初筛的参与者。由于过度频繁的筛查存在相关危害,对于低剂量CT初筛为阴性的参与者,延长筛查间隔可能是合理的。
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