Hoffman Richard M, Atallah Rami P, Struble Roger D, Badgett Robert G
University of Iowa Carver College of Medicine, Iowa City, IA, USA.
Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, USA.
J Gen Intern Med. 2020 Oct;35(10):3015-3025. doi: 10.1007/s11606-020-05951-7. Epub 2020 Jun 24.
Randomized controlled trials have evaluated the efficacy of low-dose CT (LDCT) lung cancer screening on lung cancer (LC) outcomes.
Meta-analyze LDCT lung cancer screening trials.
We identified studies by searching PubMed, Google Scholar, the Cochrane Registry, ClinicalTrials.gov , and reference lists from retrieved publications. We abstracted data on study design features, stage I LC diagnoses, LC and overall mortality, false positive results, harm from invasive diagnostic procedures, overdiagnosis, and significant incidental findings. We assessed study quality using the Cochrane risk-of-bias tool. We used random-effects models to calculate relative risks and assessed effect modulators with subgroup analyses and meta-regression.
We identified 9 studies that enrolled 96,559 subjects. The risk of bias across studies was judged to be low. Overall, LDCT screening significantly increased the detection of stage I LC, RR = 2.93 (95% CI, 2.16-3.98), I = 19%, and reduced LC mortality, RR = 0.84 (95% CI, 0.75-0.93), I = 0%. The number needed to screen to prevent an LC death was 265. Women had a lower risk of LC death (RR = 0.69, 95% CI, 0.40-1.21) than men (RR = 0.86, 95% CI, 0.66-1.13), p value for interaction = 0.11. LDCT screening did not reduce overall mortality, RR = 0.96 (95% CI, 0.91-1.01), I = 0%. The pooled false positive rate was 8% (95% CI, 4-18); subjects with false positive results had < 1 in 1000 risk of major complications following invasive diagnostic procedures. The most valid estimates for overdiagnosis and significant incidental findings were 8.9% and 7.5%, respectively.
LDCT screening significantly reduced LC mortality, though not overall mortality, with women appearing to benefit more than men. The estimated risks for false positive results, screening complications, overdiagnosis, and incidental findings were low. Long-term survival data were available only for North American and European studies limiting generalizability.
随机对照试验已评估低剂量CT(LDCT)肺癌筛查对肺癌(LC)结局的疗效。
对LDCT肺癌筛查试验进行荟萃分析。
我们通过检索PubMed、谷歌学术、考克兰系统评价数据库、ClinicalTrials.gov以及检索到的出版物的参考文献列表来确定研究。我们提取了关于研究设计特征、I期LC诊断、LC和总死亡率、假阳性结果、侵入性诊断程序的危害、过度诊断以及重要偶然发现的数据。我们使用考克兰偏倚风险工具评估研究质量。我们使用随机效应模型计算相对风险,并通过亚组分析和荟萃回归评估效应调节因素。
我们确定了9项纳入96,559名受试者的研究。各研究的偏倚风险被判定为低。总体而言,LDCT筛查显著增加了I期LC的检出率,RR = 2.93(95% CI,2.16 - 3.98),I² = 19%,并降低了LC死亡率,RR = 0.84(95% CI,0.75 - 0.93),I² = 0%。预防一例LC死亡所需筛查的人数为265。女性LC死亡风险(RR = 0.69,95% CI,0.40 - 1.21)低于男性(RR = 0.86,95% CI,0.66 - 1.13),交互作用p值 = 0.11。LDCT筛查未降低总死亡率,RR = 0.96(95% CI,0.91 - 1.01),I² = 0%。汇总的假阳性率为8%(95% CI,4 - 18);假阳性结果的受试者在接受侵入性诊断程序后发生重大并发症的风险低于千分之一。过度诊断和重要偶然发现的最有效估计值分别为8.9%和7.5%。
LDCT筛查显著降低了LC死亡率,但未降低总死亡率,女性似乎比男性受益更多。假阳性结果、筛查并发症、过度诊断和偶然发现的估计风险较低。仅北美和欧洲的研究有长期生存数据,限制了研究结果的普遍性。