Results of the two incidence screenings in the National Lung Screening Trial.
Results of the two incidence screenings in the National Lung Screening Trial.
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DOI：
10.1056/nejmoa1208962
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发表时间：
2013-09-05
期刊：
影响因子：
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通讯作者：
National Lung Screening Trial Research Team
中科院分区：
文献类型：
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作者：
Aberle DR;DeMello S;Berg CD;Black WC;Brewer B;Church TR;Clingan KL;Duan F;Fagerstrom RM;Gareen IF;Gatsonis CA;Gierada DS;Jain A;Jones GC;Mahon I;Marcus PM;Rathmell JM;Sicks J;National Lung Screening Trial Research Team
国家肺筛查试验的目的是确定与胸部X线摄影相比，低剂量螺旋计算机断层扫描（CT）每年进行三次筛查（T0，T1和T2轮）是否可以降低肺癌的死亡率。我们提出了详细的调查结果，从前两个发病率筛选（轮T1和T2）。我们评估了参与者对筛查方案的依从率、筛查和下游诊断测试的结果、肺癌病例的特征和一线治疗，并估计了两种筛查方法的性能特征。在T1和T2轮中，低剂量CT组中分别有27.9%和16.8%的参与者以及X线摄影组中分别有6.2%和5.0%的参与者观察到阳性筛查结果。低剂量CT组T1时敏感性为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时阳性预测值上升至5.2%。X线组T1时的敏感性为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时敏感性和阳性预测值均增加。在已知分期的肺癌中，T1时低剂量CT组中有87例（47.5%）为IA期，57例（31.1%）为III或IV期; T1时X线摄影组中有31例（23.5%）为IA期，78例（59.1%）为III或IV期。这些组间分期分布的差异在T2时持续存在。低剂量CT在检测早期肺癌方面更敏感，但其阳性预测值低于X线摄影。与放射照相相比，每年两次低剂量CT发病率筛查导致诊断出的晚期癌症数量减少，诊断出的早期肺癌数量增加。（由国家癌症研究所资助; NLST ClinicalTrials.gov编号，NCT 00047385。
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). 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. 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. 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.)