Randomized Study on Early Detection of Lung Cancer with MSCT in Germany Results of the First 3 Years of Follow-up After Randomization
Randomized Study on Early Detection of Lung Cancer with MSCT in Germany Results of the First 3 Years of Follow-up After Randomization
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DOI：
10.1097/jto.0000000000000530
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发表时间：
2015-06-01
影响因子：
20.4
通讯作者：
Delorme, S.
中科院分区：
文献类型：
--
作者：
Becker, N.;Motsch, E.;Delorme, S.
简介：德国肺癌筛查干预试验（LUSI）是一项欧洲随机试验，旨在研究低剂量多层计算机断层扫描（MSCT）作为肺癌筛查工具的有效性。在第一轮（患病率）筛查的评估中，我们观察到异常高的早期召回率，这使得MSCT筛查的常规应用受到质疑。由于筛查可能在随后的（发病率）筛查轮中表现不同，我们分析了(a)年度第2轮至第4轮的基本特征，现在也已经完成，以及(b)自随机化以来的前3年完整随访。方法：资料为第四轮筛选结束后的LUSI数据记录，随访3年。对筛查的基本特征，如早期回忆率、检出率、间隔期癌症以及晚期癌症的比例进行描述性评估，如果信息丰富，则对组间差异进行统计学显著性检验。结果：如果有前一轮筛查的MSCT信息，那么在随后的筛查中，早期回忆率明显低于第一轮筛查。检出率和活检率约为1%或更低，良性和恶性活检的比例：1:6 .6至1:3。结论：我们最近的数据可能不仅解决了常规MSCT筛查中召回率高的一个问题，而且表明筛查必须严格组织才能有效。性能指标与乳房x光检查相似。然而，对参与者可能产生的后果（可疑发现的诊断检查、活组织检查）比乳房x光检查更具侵入性。
Introduction: The German Lung Cancer Screening Intervention Trial (LUSI) is one of the European randomized trials investigating the efficacy of low-dose multislice computed tomography (MSCT) as a screening tool for lung cancer. In the evaluation of the first (prevalence) screening round, we observed exceptionally high early recall rates, which made the routine application of MSCT screening questionable. Because screening may behave differently in subsequent (incidence) screening rounds, we analyzed (a) basic characteristics for the annual rounds 2 to 4, which have now also been completed, and (b) the first 3 years with complete follow-up since time of randomization.Methods: Data material was the data record of LUSI after the fourth screening round and the 3-year follow-up had been completed. Basic characteristics of screening, e.g., early recall rate, detection rate, and interval cancers as well of proportion of advanced cancers, were descriptively evaluated and, if informative, group differences were tested for statistical significance.Results: Early recall rates were significantly lower in the subsequent screening rounds than in the first one if the MSCT information from the previous screening rounds was available. Detection and biopsy rates were approximately 1% or lower, ratio of benign: malignant biopsies: 1:1.6 to 1:3.Conclusion: Our recent data may not only settle one concern regarding high recall rates in routine MSCT screening but also indicate that screening must be strictly organized to be effective. Performance indicators are similar to those in mammography screening. Nevertheless, possible consequences for the participants (diagnostic workup of suspicious findings, biopsies) are more invasive than in mammography screening.