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低剂量 CT 肺癌筛查提前发现早期疾病。丹麦随机肺癌筛查试验:进行五年年度低剂量 CT 筛查后的现状。

CT screening for lung cancer brings forward early disease. The randomised Danish Lung Cancer Screening Trial: status after five annual screening rounds with low-dose CT.

机构信息

Department of Respiratory Medicine, Gentofte University Hospital, Niels Andersens Vej 65, Opgang 30A, 2900 Hellerup, Denmark.

出版信息

Thorax. 2012 Apr;67(4):296-301. doi: 10.1136/thoraxjnl-2011-200736. Epub 2012 Jan 27.

Abstract

BACKGROUND

The effects of low-dose CT screening on disease stage shift, mortality and overdiagnosis are unclear. Lung cancer findings and mortality rates are reported at the end of screening in the Danish Lung Cancer Screening Trial.

METHODS

4104 men and women, healthy heavy smokers/former smokers were randomised to five annual low-dose CT screenings or no screening. Two experienced chest radiologists read all CT scans and registered the location, size and morphology of nodules. Nodules between 5 and 15 mm without benign characteristics were rescanned after 3 months. Growing nodules (>25% volume increase and/or volume doubling time<400 days) and nodules >15 mm were referred for diagnostic workup. In the control group, lung cancers were diagnosed and treated outside the study by the usual clinical practice.

RESULTS

Participation rates were high in both groups (screening: 95.5%; control: 93.0%; p<0.001). Lung cancer detection rate was 0.83% at baseline and mean annual detection rate was 0.67% at incidence rounds (p=0.535). More lung cancers were diagnosed in the screening group (69 vs. 24, p<0.001), and more were low stage (48 vs 21 stage I-IIB non-small cell lung cancer (NSCLC) and limited stage small cell lung cancer (SCLC), p=0.002), whereas frequencies of high-stage lung cancer were the same (21 vs 16 stage IIIA-IV NSCLC and extensive stage SCLC, p=0.509). At the end of screening, 61 patients died in the screening group and 42 in the control group (p=0.059). 15 and 11 died of lung cancer, respectively (p=0.428).

CONCLUSION

CT screening for lung cancer brings forward early disease, and at this point no stage shift or reduction in mortality was observed. More lung cancers were diagnosed in the screening group, indicating some degree of overdiagnosis and need for longer follow-up.

摘要

背景

低剂量 CT 筛查对疾病分期转移、死亡率和过度诊断的影响尚不清楚。丹麦肺癌筛查试验在筛查结束时报告肺癌发现和死亡率。

方法

4104 名健康的重度吸烟者/前吸烟者被随机分配到每年进行 5 次低剂量 CT 筛查或不进行筛查。两名经验丰富的胸部放射科医生阅读所有 CT 扫描并记录结节的位置、大小和形态。没有良性特征的 5 至 15 毫米大小的结节在 3 个月后重新扫描。生长结节(>25%体积增加和/或体积倍增时间<400 天)和>15 毫米的结节被转诊进行诊断性检查。在对照组中,肺癌是通过常规临床实践在研究之外诊断和治疗的。

结果

两组的参与率都很高(筛查组:95.5%;对照组:93.0%;p<0.001)。基线时肺癌检出率为 0.83%,发病率轮次的年均检出率为 0.67%(p=0.535)。筛查组诊断出更多的肺癌(69 例比 24 例,p<0.001),且更多为低分期(48 例 I 期至 IIB 期非小细胞肺癌(NSCLC)和局限期小细胞肺癌(SCLC),p=0.002),而高分期肺癌的频率相同(21 例 IIIA-IV 期 NSCLC 和广泛期 SCLC,p=0.509)。筛查结束时,筛查组有 61 例患者死亡,对照组有 42 例死亡(p=0.059)。分别有 15 例和 11 例死于肺癌(p=0.428)。

结论

肺癌 CT 筛查可提前发现疾病,但目前并未观察到分期转移或死亡率降低。筛查组诊断出更多的肺癌,表明存在一定程度的过度诊断,需要进行更长时间的随访。

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