From the Icahn School of Medicine at Mount Sinai, 1 Gustave Levy Place, New York, NY 10029 (R.Y., C.I.H., D.F.Y.); and Weill Cornell Medical College, New York, NY (J.P.S.).
Radiology. 2014 Nov;273(2):591-6. doi: 10.1148/radiol.14132950. Epub 2014 Jun 19.
To determine the usefulness of alternative nodule size thresholds in a population undergoing computed tomographic (CT) screening for lung cancer and to compare the reported International Early Lung Cancer Action Program ( I-ELCAP International Early Lung Cancer Action Program ) results with the National Lung Screening Trial ( NLST National Lung Screening Trial ) results.
The institutional review board approved this retrospective analysis. Informed consent was obtained according to HIPAA compliance. Findings in the CT cohort in the NLST National Lung Screening Trial of 25 813 participants who underwent baseline CT in 2002-2004 were reviewed. The frequency of solid and part-solid pulmonary nodules and the lung cancer diagnoses using an alternative nodule threshold of 5.0, 6.0, 7.0, 8.0, and 9.0 mm were determined. Proportional reduction in the frequency of positive results and their 95% confidence intervals using each of the alternative thresholds were calculated.
The frequency of positive results in the baseline round in the CT arm of the NLST National Lung Screening Trial using the definition of a positive result of any parenchymal, solid or part-solid, noncalcified nodule of 5.0 mm or larger was 15.8% (4080 of 25 813). Using alternative thresholds of 6.0, 7.0, 8.0, and 9.0 mm, the frequencies of positive results were 10.5% (2700 of 25 813, 7.2% (1847 of 25 813), 5.3% (1362 of 25 813), and 4.1% (1007 of 25 813), respectively, and the corresponding proportional reduction in additional CT scans would have been 33.8% (1380 of 1480), 54.7% (2233 of 4080), 66.6% (2718 of 4080), and 73.8% (3013 of 4080), respectively. Concomitantly, the proportion of lung cancer diagnoses determined within the first 12 months would be delayed up to 9 months for 0.9% (two of 232), 2.6% (six of 232), 6.0% (14 of 232), and 9.9% (23 of 232) of the patients, respectively.
The NLST National Lung Screening Trial results are similar to those previously reported for the I-ELCAP International Early Lung Cancer Action Program and suggest that, even for high-risk participants in the NLST National Lung Screening Trial , higher thresholds of nodule size should be considered and prospectively evaluated.
确定在接受计算机断层扫描（CT）肺癌筛查的人群中使用替代结节大小阈值的有用性，并将报告的国际早期肺癌行动计划（I-ELCAP）结果与国家肺癌筛查试验（NLST）结果进行比较。
机构审查委员会批准了这项回顾性分析。根据 HIPAA 合规性获得了知情同意。回顾了 2002-2004 年基线 CT 检查的 NLST 国家肺癌筛查试验 CT 队列中 25813 名参与者的实性和部分实性肺结节的频率以及使用替代结节阈值 5.0、6.0、7.0、8.0 和 9.0 mm 的肺癌诊断。使用每个替代阈值计算阳性结果的频率及其 95%置信区间的比例减少。
NLST 国家肺癌筛查试验 CT 臂中使用任何实质、实性或部分实性、非钙化结节 5.0 mm 或更大的阳性结果定义的基线轮阳性结果的频率为 15.8%（25813 例中的 4080 例）。使用替代阈值 6.0、7.0、8.0 和 9.0mm，阳性结果的频率分别为 10.5%（25813 例中的 2700 例）、7.2%（25813 例中的 1847 例）、5.3%（25813 例中的 1362 例）和 4.1%（25813 例中的 1007 例），相应的额外 CT 扫描比例减少分别为 33.8%（1380 例中的 1480 例）、54.7%（2233 例中的 4080 例）、66.6%（2718 例中的 4080 例）和 73.8%（3013 例中的 4080 例）。同时，0.9%（232 例中的 2 例）、2.6%（232 例中的 6 例）、6.0%（232 例中的 14 例）和 9.9%（232 例中的 23 例）的患者中，确定肺癌诊断的比例将延迟长达 9 个月。
NLST 国家肺癌筛查试验结果与之前报道的 I-ELCAP 国际早期肺癌行动计划结果相似，表明即使对于 NLST 国家肺癌筛查试验中的高危参与者，也应考虑并前瞻性评估更高的结节大小阈值。
