The National Lung Screening Trial: Overview and Study Design

The National Lung Screening Trial: Overview and Study Design
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DOI:
10.1148/radiol.10091808
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发表时间:
2011-01-01
期刊:
影响因子:
19.7
通讯作者:
Gatsonis, Constantine A.
Gatsonis, Constantine A.
中科院分区:
医学1区
文献类型:
--
作者:
Gatsonis, Constantine A.

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国家肺部筛查试验(NLST)是一项随机多中心研究,比较低剂量螺旋计算机断层扫描(CT)和胸部x线摄影在筛查当前和以前的老年重度吸烟者中早期发现肺癌的效果,肺癌是美国癌症相关死亡的主要原因。手术切除IA期疾病的5年生存率接近70%;然而,超过75%的患者患有无法治愈的局部晚期或转移性疾病,后者的5年生存率低于5%。如果在临床前阶段通过足够早的筛查发现无症状肺癌,治疗应该更有效,死亡的可能性应该降低,这似乎是合理的。基于这些原因,人们对肺癌低剂量CT筛查有着强烈的兴趣和直观的吸引力。然而,将生存期作为筛查有效性的决定因素,会因提前期、时间长度和过度诊断的偏差而混淆。尽管以前有过尝试,但没有任何测试显示可以降低肺癌死亡率,这是一个绕过筛查偏见的终点,并在随机对照试验中评估时提供了明确的益处衡量标准,该试验可以比较筛查个体和未接受筛查干预的对照组之间的死亡率。NLST就是这样一个试验。介绍了NLST的基本原理和设计。(c) rsna, 2010
The National Lung Screening Trial (NLST) is a randomized multicenter study comparing low-dose helical computed tomography (CT) with chest radiography in the screening of older current and former heavy smokers for early detection of lung cancer, which is the leading cause of cancer-related death in the United States. Five-year survival rates approach 70% with surgical resection of stage IA disease; however, more than 75% of individuals have incurable locally advanced or metastatic disease, the latter having a 5-year survival of less than 5%. It is plausible that treatment should be more effective and the likelihood of death decreased if asymptomatic lung cancer is detected through screening early enough in its preclinical phase. For these reasons, there is intense interest and intuitive appeal in lung cancer screening with low-dose CT. The use of survival as the determinant of screening effectiveness is, however, confounded by the well-described biases of lead time, length, and overdiagnosis. Despite previous attempts, no test has been shown to reduce lung cancer mortality, an endpoint that circumvents screening biases and provides a definitive measure of benefit when assessed in a randomized controlled trial that enables comparison of mortality rates between screened individuals and a control group that does not undergo the screening intervention of interest. The NLST is such a trial. The rationale for and design of the NLST are presented. (C) RSNA, 2010