Results of the Randomized Danish Lung Cancer Screening Trial with Focus on High-Risk Profiling
Results of the Randomized Danish Lung Cancer Screening Trial with Focus on High-Risk Profiling
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DOI：
10.1164/rccm.201505-1040oc
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发表时间：
2016-03-01
影响因子：
24.7
通讯作者：
Pedersen, Jesper H.
中科院分区：
文献类型：
--
作者：
Wille, Mathilde M. W.;Dirksen, Asger;Pedersen, Jesper H.
理论基础：截至2015年4月，丹麦肺癌筛查试验的参与者自最后一次筛查以来已被跟踪至少5年。目的：报道死亡率、死因和肺癌结果，以探讨计算机断层扫描(CT)筛查的效果。方法：总共4,104名年龄在50-70岁之间、吸烟至少20包年的参与者被随机分为五组，每年进行五次低剂量CT扫描(研究组)或不进行筛查(对照组)。测量和主要结果：关于死亡日期和原因、肺癌诊断、癌症分期、组织学研究从国家登记处获得。两组的肺癌死亡率(危险比1·03；95%可信区间0·66~1·6；P=0.888)和全因死亡率(危险比1·02；95%可信区间0·82~1·27；P=0.867)差异无统计学意义。筛查组比未筛查组发现更多的癌症(分别为100vs.53；P<；0.001)，特别是腺癌(分别为58vs.18；P<；0.001)。与对照组相比，筛查组早期癌症(I期和II期分别为54例和10例；P<；0.001例)和Ma期癌症(15例和3例；P=0.009)的发生率较高。对照组中IV期癌症的发生率高于筛查组(分别为32例和23例；P=0.278)。对于最高分期的癌症(T4N3M1，分别为21例和8例；P=0.025)，这一差异在统计上具有显著意义，表明绝对的分期转移。年龄较大的参与者、患有慢性阻塞性肺病和吸烟超过35包年的人死于肺癌的风险显著增加，而筛查组的死亡人数没有显著减少。结论：CT筛查对肺癌死亡率没有统计学意义的影响，但后组高危亚组分析的结果显示出不显著的趋势，似乎与全国肺筛查试验的结果一致。
Rationale: As of April 2015, participants in the Danish Lung Cancer Screening Trial had been followed for at least 5 years since their last screening.Objectives: Mortality, causes of death, and lung cancer findings are reported to explore the effect of computed tomography (CT) screening.Methods: A total of 4,104 participants aged 50-70 years at the time of inclusion and with a minimum 20 pack-years of smoking were randomized to have five annual low-dose CT scans (Study group) or no screening (control group).Measurements and Main Results: Follow-up information regarding date and cause of death, lung cancer diagnosis, cancer stage, and histology was obtained from national registries. No differences between the two groups in lung cancer mortality (hazard ratio, 1.03; 95% confidence interval, 0.66-1.6; P = 0.888) or all-cause mortality (hazard ratio, 1.02; 95% confidence interval, 0.82-1.27; P = 0.867) were observed. More cancers were found in the screening group than in the no-screening group (100 vs. 53, respectively; P < 0.001), particularly adenocarcinomas (58 vs. 18, respectively; P < 0.001). More early-stage cancers (stages I and II, 54 vs. 10, respectively; P < 0.001) and stage Ma cancers (15 vs. 3, respectively; P = 0.009) were found in the screening group than in the control group. Stage IV cancers were nonsignificantly more frequent in the control group than in the screening group (32 vs. 23, respectively; P = 0.278). For the highest-stage cancers (T4N3M1, 21 vs. 8, respectively; P = 0.025), this difference was statistically significant, indicating an absolute stage shift. Older participants, those with chronic obstructive pulmonary disease, and those with more than 35 pack-years of smoking had a significantly increased risk of death due to lung cancer, with nonsignificantly fewer deaths in the screening group.Conclusions: No statistically significant effects of CT screening on lung cancer mortality were found, but the results of post hoc high-risk subgroup analyses showed nonsignificant trends that seem to be in good agreement with the results of the National Lung Screening Trial.