国家肺癌筛查试验中的两项发病筛查结果。
Results of the two incidence screenings in the National Lung Screening Trial.
机构信息
Department of Radiological Sciences, David Geffen School of Medicine at the University of California at Los Angeles (UCLA), Los Angeles, CA 90024, USA.
出版信息
N Engl J Med. 2013 Sep 5;369(10):920-31. doi: 10.1056/NEJMoa1208962.
BACKGROUND
The National Lung Screening Trial was conducted to determine whether three annual screenings (rounds T0, T1, and T2) with low-dose helical computed tomography (CT), as compared with chest radiography, could reduce mortality from lung cancer. We present detailed findings from the first two incidence screenings (rounds T1 and T2).
METHODS
We evaluated the rate of adherence of the participants to the screening protocol, the results of screening and downstream diagnostic tests, features of the lung-cancer cases, and first-line treatments, and we estimated the performance characteristics of both screening methods.
RESULTS
At the T1 and T2 rounds, positive screening results were observed in 27.9% and 16.8% of participants in the low-dose CT group and in 6.2% and 5.0% of participants in the radiography group, respectively. In the low-dose CT group, the sensitivity was 94.4%, the specificity was 72.6%, the positive predictive value was 2.4%, and the negative predictive value was 99.9% at T1; at T2, the positive predictive value increased to 5.2%. In the radiography group, the sensitivity was 59.6%, the specificity was 94.1%, the positive predictive value was 4.4%, and the negative predictive value was 99.8% at T1; both the sensitivity and the positive predictive value increased at T2. Among lung cancers of known stage, 87 (47.5%) were stage IA and 57 (31.1%) were stage III or IV in the low-dose CT group at T1; in the radiography group, 31 (23.5%) were stage IA and 78 (59.1%) were stage III or IV at T1. These differences in stage distribution between groups persisted at T2.
CONCLUSIONS
Low-dose CT was more sensitive in detecting early-stage lung cancers, but its measured positive predictive value was lower than that of radiography. As compared with radiography, the two annual incidence screenings with low-dose CT resulted in a decrease in the number of advanced-stage cancers diagnosed and an increase in the number of early-stage lung cancers diagnosed. (Funded by the National Cancer Institute; NLST ClinicalTrials.gov number, NCT00047385.).
背景
国家肺癌筛查试验旨在确定与胸部 X 射线相比，每年进行三次低剂量螺旋 CT（T0、T1 和 T2 轮）筛查是否能降低肺癌死亡率。我们呈现了前两轮发病率筛查（T1 和 T2 轮）的详细结果。
方法
我们评估了参与者对筛查方案的依从性、筛查和下游诊断检测的结果、肺癌病例的特征以及一线治疗情况，并估计了两种筛查方法的性能特征。
结果
在 T1 和 T2 轮中，低剂量 CT 组分别有 27.9%和 16.8%的参与者筛查结果阳性，而 X 射线组分别有 6.2%和 5.0%的参与者筛查结果阳性。在低剂量 CT 组中，T1 时的灵敏度为 94.4%，特异性为 72.6%，阳性预测值为 2.4%，阴性预测值为 99.9%；T2 时阳性预测值增加到 5.2%。在 X 射线组中，T1 时的灵敏度为 59.6%，特异性为 94.1%，阳性预测值为 4.4%，阴性预测值为 99.8%；T2 时灵敏度和阳性预测值均增加。在已知分期的肺癌中，T1 时低剂量 CT 组有 87（47.5%）例为 IA 期，57（31.1%）例为 III 或 IV 期；X 射线组有 31（23.5%）例为 IA 期，78（59.1%）例为 III 或 IV 期。这种组间分期分布的差异在 T2 时仍然存在。
结论
低剂量 CT 检测早期肺癌更敏感，但阳性预测值低于 X 射线。与 X 射线相比，每年两次低剂量 CT 发病率筛查导致诊断为晚期癌症的数量减少，而早期肺癌的诊断数量增加。（由美国国立癌症研究所资助；NLST 临床试验.gov 编号，NCT00047385）。
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