随机试验中 CT 容积筛查降低肺癌死亡率
Reduced Lung-Cancer Mortality with Volume CT Screening in a Randomized Trial.
机构信息
From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.
出版信息
N Engl J Med. 2020 Feb 6;382(6):503-513. doi: 10.1056/NEJMoa1911793. Epub 2020 Jan 29.
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.).
背景
关于基于体积的低剂量计算机断层扫描（CT）筛查是否可以降低男性既往和当前吸烟者的肺癌死亡率，随机试验的数据有限。
方法
总共 13195 名年龄在 50 至 74 岁的男性（主要分析）和 2594 名女性（亚组分析）被随机分配在 T0（基线）、第 1 年、第 3 年和第 5.5 年进行 CT 筛查或不进行筛查。我们通过与荷兰和比利时的国家登记处的链接获得了癌症诊断以及死亡日期和原因的数据，审查委员会在可能的情况下确认了肺癌是死亡原因。所有参与者的最低随访时间为 10 年，截至 2015 年 12 月 31 日。
结果
在男性中，CT 筛查的平均依从率为 90.0%。平均而言，9.2%的筛查参与者进行了至少一次额外的 CT 扫描（最初不确定）。可疑结节的总体转诊率为 2.1%。10 年随访期间，筛查组的肺癌发病率为每 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。与对照组相比，筛查组 10 年时死于肺癌的累积率比值为 0.76（95%置信区间[CI]，0.61 至 0.94；P=0.01），与第 8 年和第 9 年的值相似。在女性中，10 年随访时的比率为 0.67（95%CI，0.38 至 1.14），第 7 年至第 9 年的值为 0.41 至 0.52。
结论
在这项涉及高危人群的试验中，与未接受筛查的人群相比，接受容积 CT 筛查的人群肺癌死亡率显著降低。对于提示肺癌的结果，后续程序的比率较低。（由荷兰卫生研究与发展组织和其他组织资助；NELSON 荷兰试验登记号，NL580.）。
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