Lung cancer screening with low-dose spiral computed tomography: evidence from a pooled analysis of two Italian randomized trials.
Lung cancer screening with low-dose spiral computed tomography: evidence from a pooled analysis of two Italian randomized trials.
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DOI：
10.1097/cej.0000000000000264
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发表时间：
2017-07
期刊：
影响因子：
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通讯作者：
Pastorino U
中科院分区：
文献类型：
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作者：
Infante M;Sestini S;Galeone C;Marchianò A;Lutman FR;Angeli E;Calareso G;Pelosi G;Sozzi G;Silva M;Sverzellati N;Cavuto S;La Vecchia C;Santoro A;Alloisio M;Pastorino U
低剂量计算机断层扫描(LDCT)筛查肺癌(LC)的好处和坏处是有争议的。美国国家肺部筛查试验的阳性结果在欧洲试验中并不明显，可能是因为样本量较小。为了解决这个问题，我们对两个意大利随机对照试验进行了患者水平的合并分析。来自但丁和轻度试验的数据被结合在一起，在LDCT组中总共有3640人，在控制组中有2909人。LC和总死亡率采用多变量风险比(HR)和按研究分层的对数等级检验进行分析。中位随访期为8.2年，LDCT组为30480人年，对照组为22157人年。LDCT组共有192名患者发展为LC，对照组有105名患者发展为LC。LDCT组一半的LC患者患有IA或IB期癌症，而对照组的这一比例为21%。LDCT组和对照组每10万人年的总死亡率分别为925和1074，LC死亡率分别为299和357。与对照组相比，LDCT组的多变量合并总死亡率比为0.89(95%可信区间：0.74-1.06)，LC死亡率比为0.83(95%可信区间：0.61-1.12)。目前的合并分析显示，与对照组相比，接受LDCT筛查的患者的总死亡率降低了11%，但并不显著。对所有欧洲试验的综合分析将有助于评估LDCT筛查的真正益处。
The benefits and harms of lung cancer (LC) screening with low-dose computed tomography (LDCT) are debatable. Positive results from the US National Lung Screening Trial were not evident in the European trials, possibly due to their smaller sample sizes. To address this issue, we conducted a patient-level pooled analysis of two Italian randomized controlled trials. Data from DANTE and MILD trials were combined for a total of 3640 individuals in the LDCT arm and 2909 in the control arm. LC and overall mortality were analyzed using multivariate hazard ratios (HRs) and log-rank tests stratified by study. The median follow-up was 8.2 years, with a total of 30 480 person-years in the LDCT arm and 22 157 in the control arm. A total of 192 patients developed LC in the LDCT arm and 105 in the control arm. Half of the LC cases in the LDCT arm had stage IA or IB cancer, as compared with 21% in the control arm. Overall mortality rates/100 000 person-years were 925 in the LDCT arm and 1074 in the control arm, and LC mortality rates were 299 and 357, respectively. The multivariate pooled overall mortality HR was 0.89 (95% confidence interval: 0.74–1.06) and the LC mortality HR was 0.83 (95% confidence interval: 0.61–1.12) for the LDCT arm as compared with the control arm. The present pooled analysis shows a nonsignificant 11% reduction in overall mortality in individuals undergoing LDCT screening as compared with the control arm. A pooled analysis of all European trials would be a useful contribution to assess the real benefit of LDCT screening.