荷兰鹿特丹伊拉斯姆斯大学医学中心Harry J. de Koning研究小组在研究中取得进展。他们进行了容积CT筛查降低肺癌死亡率的随机试验。2020年1月29日出版的《新英格兰医学杂志》发表了这项成果。

在曾经和现今吸烟的男性中，基于容积的低剂量CT筛查能否降低肺癌死亡率的随机试验很少。

研究组招募了13195名男性参与者（初步分析）和2594名女性参与者（亚组分析），年龄为50-74岁，将其随机分配至基线、1年、3年和5.5年进行CT筛查（筛查组）或不筛查（对照组）。通过荷兰和比利时国家登记处获得癌症诊断、死亡日期和死因。截至2015年12月31日，研究组对参与者进行了至少10年的随访。

男性CT筛查的平均依从性是90%。平均来说，9.2%的筛查者至少接受了一次额外CT扫描。可疑结节的总转诊率为2.1%。随访10年后，筛查组肺癌发病率为每1000人年5.58例，对照组为每1000人年4.91例；肺癌死亡率分别为每1000人年2.50例和3.30例，差异显著。

与对照组相比，筛查组随访10年肺癌死亡率的累积比值比为0.76，与随访8年和9年的数值相似。女性随访10年的比值比为0.67，随访7年为0.41，9年为0.52。

总之，在这项涉及高危人群的试验中，接受容积CT筛查患者的肺癌死亡率明显低于未接受筛查的患者。

附：英文原文

Title: Reduced Lung-Cancer Mortality with Volume CT Screening in a Randomized Trial

Author: Harry J. de Koning, M.D., Ph.D.,, Carlijn M. van der Aalst, Ph.D.,, Pim A. de Jong, M.D., Ph.D.,, Ernst T. Scholten, M.D., Ph.D.,, Kristiaan Nackaerts, M.D., Ph.D.,, Marjolein A. Heuvelmans, M.D., Ph.D.,, Jan-Willem J. Lammers, M.D., Ph.D.,, Carla Weenink, M.D.,, Uraujh Yousaf-Khan, M.D., Ph.D.,, Nanda Horeweg, M.D., Ph.D.,, Susan van ’t Westeinde, M.D., Ph.D.,, Mathias Prokop, M.D., Ph.D.,, Willem P. Mali, M.D., Ph.D.,, Firdaus A.A. Mohamed Hoesein, M.D., Ph.D.,, Peter M.A. van Ooijen, Ph.D.,, Joachim G.J.V. Aerts, M.D., Ph.D.,, Michael A. den Bakker, M.D., Ph.D.,, Erik Thunnissen, M.D., Ph.D.,, Johny Verschakelen, M.D., Ph.D.,, Rozemarijn Vliegenthart, M.D., Ph.D.,, Joan E. Walter, M.D., Ph.D.,, Kevin ten Haaf, Ph.D.,, Harry J.M. Groen, M.D., Ph.D.,, and Matthijs Oudkerk, M.D., Ph.D.

Issue&Volume: 2020-01-29

Abstract:

Background
There are limited data from randomized trials regarding whether volume-based, low-dose computed tomographic (CT) screening can reduce lung-cancer mortality among male former and current smokers.

Methods
A total of 13,195 men (primary analysis) and 2594 women (subgroup analyses) between the ages of 50 and 74 were randomly assigned to undergo CT screening at T0 (baseline), year 1, year 3, and year 5.5 or no screening. We obtained data on cancer diagnosis and the date and cause of death through linkages with national registries in the Netherlands and Belgium, and a review committee confirmed lung cancer as the cause of death when possible. A minimum follow-up of 10 years until December 31, 2015, was completed for all participants.

Results
Among men, the average adherence to CT screening was 90.0%. On average, 9.2% of the screened participants underwent at least one additional CT scan (initially indeterminate). The overall referral rate for suspicious nodules was 2.1%. At 10 years of follow-up, the incidence of lung cancer was 5.58 cases per 1000 person-years in the screening group and 4.91 cases per 1000 person-years in the control group; lung-cancer mortality was 2.50 deaths per 1000 person-years and 3.30 deaths per 1000 person-years, respectively. The cumulative rate ratio for death from lung cancer at 10 years was 0.76 (95% confidence interval [CI], 0.61 to 0.94; P=0.01) in the screening group as compared with the control group, similar to the values at years 8 and 9. Among women, the rate ratio was 0.67 (95% CI, 0.38 to 1.14) at 10 years of follow-up, with values of 0.41 to 0.52 in years 7 through 9.

Conclusions
In this trial involving high-risk persons, lung-cancer mortality was significantly lower among those who underwent volume CT screening than among those who underwent no screening. There were low rates of follow-up procedures for results suggestive of lung cancer. (Funded by the Netherlands Organization of Health Research and Development and others; NELSON Netherlands Trial Register number, NL580.)

DOI: 10.1056/NEJMoa1911793

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1911793