Randomized study on early detection of lung cancer with MSCT in Germany: study design and results of the first screening round
Randomized study on early detection of lung cancer with MSCT in Germany: study design and results of the first screening round
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DOI：
10.1007/s00432-012-1228-9
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发表时间：
2012-09-01
影响因子：
3.6
通讯作者：
Delorme, S.
中科院分区：
文献类型：
--
作者：
Becker, N.;Motsch, E.;Delorme, S.
低剂量多层螺旋CT(MSCT)能发现许多预后良好的早期肺癌，但它是否能降低肺癌死亡率以及成本还不够深入。本研究的范围是在欧洲共同的努力下检查MSCT筛查是否能够将肺癌死亡率降低至少20%，以及在多大程度上可以实现这一不良副作用。总共4052名重度吸烟的男性和女性通过基于人群的方法招募，并随机分为筛查组和对照组，筛查组每年进行五次MSCT筛查和初步戒烟咨询，对照组接受初步戒烟咨询和五次年度问卷调查。在第一轮筛查中，2029名参与者接受了MSCT，提供了1488个阴性和540个可疑的筛查，早期回忆(早期召回率26.6%)导致31次活组织检查(活检率1.5%)和22次确诊肺癌(检出率1.1%)。其中腺癌15例，鳞状细胞癌3例，小细胞肺癌1例，其他3例，其中临床I期18例，II期1例，III期3例。该研究继续完成第二轮筛查，对于第一批参与者，甚至是最后一轮筛查。副作用的精确数量和早期召回率高的问题尚未解决，目前排除了MSCT作为肺癌筛查工具的推荐。
Low-dose multislice-CT (MSCT) detects many early-stage lung cancers with good prognosis, but whether it decreases lung cancer mortality and at which costs is yet insufficiently explored. Scope of the present study is to examine within a common European effort whether MSCT screening is capable to reduce the lung cancer mortality by at least 20 % and at which amount of undesired side effects this could be achieved.Overall 4,052 heavy smoking men and women were recruited by a population-based approach and randomized into a screening arm with five annual MSCT screens and an initial quit-smoking counseling, and a control arm with initial quit-smoking counseling and five annual questionnaire inquiries.In the first screening round, 2,029 participants received a MSCT providing 1,488 negative and 540 suspicious screens with early recalls (early recall rate 26.6 %) leading to 31 biopsies (biopsy rate 1.5 %) and 22 confirmed lung cancers (detection rate 1.1 %). Among the lung cancers, 15 were adenocarcinomas, 3 squamous cell carcinomas, one small-cell lung cancer, and 3 others, whereby 18 were in clinical stage I, one in stage II, and 3 in stage III. One interval cancer occurred.The indicated performance indicators fit into the range observed in comparable trials. The study continues finalizing the second screening round and for the first participants even the last screening round. The unresolved issue of the precise amount of side effects and the high early recall rate precludes currently the recommendation of MSCT as screening tool for lung cancer.