A Randomized Study of Lung Cancer Screening with Spiral Computed Tomography Three-year Results from the DANTE Trial

A Randomized Study of Lung Cancer Screening with Spiral Computed Tomography Three-year Results from the DANTE Trial
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DOI:
10.1164/rccm.200901-0076oc
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发表时间:
2009-09-01
影响因子:
24.7
通讯作者:
Ravasi, Gianluigi
Ravasi, Gianluigi
中科院分区:
医学1区
文献类型:
--
作者:
Infante, Maurizio;Cavuto, Silvio;Ravasi, Gianluigi

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目的:探讨低剂量螺旋CT(LDCT)筛查对肺癌死亡率的影响。次要终点是发病率、诊断阶段和可切除性。方法:男性受试者,年龄60~75岁,吸烟者20年或以上,随机分为LDCT筛查组和对照组。所有参与者都接受了基线的、仅一次的胸部X光和痰细胞学检查。筛查组受试者每年进行LDCT检查,每年重复4年,而对照组仅每年进行一次体检。测量和主要结果:总共2,811名受试者被随机纳入(LDCT,1,276;对照组,1,196)。中位随访33个月后,接受低密度CT的患者中有60例(4.7%)发现肺癌,而对照组中有34例(2.8%)发现肺癌(P=0.016)。两组的可切除率相似。LDCT发现的I期疾病患者较多(54例比34%;P=0.06),筛查组因合并症状而发现的病例较少。然而,晚期肺癌病例的数量与对照组相同。低密度CT组和对照组分别有20例(1.6%)和20例(1.7%)死于肺癌,26例和25例分别死于其他原因。结论:低密度CT筛查肺癌带来的死亡率收益可能远低于预期。
Rationale: Screening for lung cancer with modern imaging technology may decrease lung cancer mortality, but encouraging results have only been obtained in uncontrolled studies.Objectives: To explore the effect of screening with low-dose spiral computed tomography (LDCT) on lung cancer mortality. Secondary endpoints are incidence, stage at diagnosis, and resectability.Methods: Male subjects, aged 60 to 75 years, smokers of 20 or more pack-years, were randomized to screening with LDCT or control groups. All participants underwent a baseline, once-only chest X-ray and sputum cytology examination. Screening-arm subjects had LDCT upon accrual to be repeated every year for 4 years, whereas controls had a yearly medical examination only.Measurements and Main Results: A total of 2,811 subjects were randomized and 2,472 were enrolled (LDCT, 1,276; control, 1,196). After a median follow-up of 33 months, lung cancer was detected in 60 (4.7%) patients receiving LDCT and 34 (2.8%) control subjects (P = 0.016). Resectability rates were similar in both groups. More patients with stage I disease were detected by LDCT (54 vs. 34%; P = 0.06) and fewer cases were detected in the screening arm due to intercurrent symptoms. However, the number of advanced lung cancer cases was the same as in the control arm. Twenty patients in the LDCT group (1.6%) and 20 controls (1.7%) died of lung cancer, whereas 26 and 25 died of other causes, respectively.Conclusions: The mortality benefit from lung cancer screening by LDCT might be far smaller than anticipated.