Performance of Lung-RADS in the National Lung Screening Trial: A Retrospective Assessment
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Abstract
Background:
Lung cancer screening with low-dose computed tomography (LDCT) has been recommended, based primarily on the results of the NLST (National Lung Screening Trial). The American College of Radiology recently released Lung-RADS, a classification system for LDCT lung cancer screening.
Objective:
To retrospectively apply the Lung-RADS criteria to the NLST.
Design:
Secondary analysis of a group from a randomized trial.
Setting:
33 U.S. screening centers.
Patients:
Participants were randomly assigned to the LDCT group of the NLST, were aged 55 to 74 years, had at least a 30–pack-year history of smoking, and were current smokers or had quit within the past 15 years.
Intervention:
3 annual LDCT lung cancer screenings.
Measurements:
Lung-RADS classifications for LDCT screenings. Lung-RADS categories 1 to 2 constitute negative screening results, and categories 3 to 4 constitute positive results.
Results:
Of 26 722 LDCT group participants, 26 455 received a baseline screening; 48 671 screenings were done after baseline. At baseline, the false-positive result rate (1 minus the specificity rate) for Lung-RADS was 12.8% (95% CI, 12.4% to 13.2%) versus 26.6% (CI, 26.1% to 27.1%) for the NLST; after baseline, the false-positive result rate was 5.3% (CI, 5.1% to 5.5%) for Lung-RADS versus 21.8% (CI, 21.4% to 22.2%) for the NLST. Baseline sensitivity was 84.9% (CI, 80.8% to 89.0%) for Lung-RADS versus 93.5% (CI, 90.7% to 96.3%) for the NLST, and sensitivity after baseline was 78.6% (CI, 74.6% to 82.6%) for Lung-RADS versus 93.8% (CI, 91.4% to 96.1%) for the NLST.
Limitation:
Lung-RADS criteria were applied retrospectively.
Conclusion:
Lung-RADS may substantially reduce the false-positive result rate; however, sensitivity is also decreased. The effect of using Lung-RADS criteria in clinical practice must be carefully studied.
Primary Funding Source:
National Institutes of Health.
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References
1.
Moyer VA; U.S. Preventive Services Task Force. Screening for lung cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014;160:330-8. [PMID: 24378917] doi: 10.7326/M13-2771
2.
Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, et al; National Lung Screening Trial Research Team. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011;365:395-409. [PMID: 21714641] doi: 10.1056/NEJMoa1102873
3.
Gierada DS, Pinsky P, Nath H, Chiles C, Duan F, Aberle DR. Projected outcomes using different nodule sizes to define a positive CT lung cancer screening examination. J Natl Cancer Inst. 2014;106. [PMID: 25326638] doi: 10.1093/jnci/dju284
4.
Henschke CI, Yip R, Yankelevitz DF, Smith JP; International Early Lung Cancer Action Program Investigators. Definition of a positive test result in computed tomography screening for lung cancer: a cohort study. Ann Intern Med. 2013;158:246-52. [PMID: 23420233] doi: 10.7326/0003-4819-158-4-201302190-00004
5.
MacMahon H, Austin JH, Gamsu G, Herold CJ, Jett JR, Naidich DP, et al; Fleischner Society. Guidelines for management of small pulmonary nodules detected on CT scans: a statement from the Fleischner Society [Editorial]. Radiology. 2005;237:395-400. [PMID: 16244247]
6.
National Comprehensive Cancer Network. Lung Cancer Screening Version 1.2014. NCCN Clinical Practice Guidelines in Oncology. Fort Washington, PA: National Comprehensive Cancer Network; 2013. Accessed at www.nccn.org/professionals/physician_gls/f_guidelines.asp#detection on 26 January 2015.
7.
Naidich DP, Bankier AA, MacMahon H, Schaefer-Prokop CM, Pistolesi M, Goo JM, et al. Recommendations for the management of subsolid pulmonary nodules detected at CT: a statement from the Fleischner Society. Radiology. 2013;266:304-17. [PMID: 23070270] doi: 10.1148/radiol.12120628
8.
Church TR, Black WC, Aberle DR, Berg CD, Clingan KL, Duan F, et al; National Lung Screening Trial Research Team. Results of initial low-dose computed tomographic screening for lung cancer. N Engl J Med. 2013;368:1980-91. [PMID: 23697514] doi: 10.1056/NEJMoa1209120
9.
Aberle DR, DeMello S, Berg CD, Black WC, Brewer B, Church TR, et al; National Lung Screening Trial Research Team. Results of the two incidence screenings in the National Lung Screening Trial. N Engl J Med. 2013;369:920-31. [PMID: 24004119] doi: 10.1056/NEJMoa1208962
10.
Horeweg N, van der Aalst CM, Vliegenthart R, Zhao Y, Xie X, Scholten ET, et al. Volumetric computed tomography screening for lung cancer: three rounds of the NELSON trial. Eur Respir J. 2013;42:1659-67. [PMID: 23845716] doi: 10.1183/09031936.00197712
11.
American College of Radiology. Lung CT Screening Reporting and Data System (Lung-RADS). Accessed at www.acr.org/Quality-Safety/Resources/LungRADS on 11 August 2014.
12.
Aberle DR, Berg CD, Black WC, Church TR, Fagerstrom RM, Galen B, et al; National Lung Screening Trial Research Team. The National Lung Screening Trial: overview and study design. Radiology. 2011;258:243-53. [PMID: 21045183] doi: 10.1148/radiol.10091808
13.
Saeki H, Tango T. Non-inferiority test and confidence interval for the difference in correlated proportions in diagnostic procedures based on multiple raters. Stat Med. 2011;30:3313-27. [PMID: 21953516] doi: 10.1002/sim.4364
14.
Moskowitz CS, Pepe MS. Comparing the predictive values of diagnostic tests: sample size and analysis for paired study designs. Clin Trials. 2006;3:272-9. [PMID: 16895044]
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Published In
Annals of Internal Medicine
Volume 162 • Number 7 • 7 April 2015
Pages: 485 - 491
History
Published online: 7 April 2015
Published in issue: 7 April 2015
Keywords
Copyright
© 2015 American College of Physicians.
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Performance of Lung-RADS in the National Lung Screening Trial: A Retrospective Assessment. Ann Intern Med.2015;162:485-491. [Epub 7 April 2015]. doi:10.7326/M14-2086
Performance of Lung-RADS in the National Lung Screening Trial: A Retrospective Assessment. Ann Intern Med.2015;162:485-491. [Epub 7 April 2015]. doi:10.7326/M14-2086
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Pure groundglass nodules: Controversial in Lung RADS category 2
if retrospectively applying the Lung-RADS criteria to the NLST[1, 2]. Therefore sensitivity is also decreased. Pure ground glass nodule (GGN) measuring less than 20 mm are lung-RADS negative (and NLST screen-detected). In general, lung cancer presenting with pure GGN measuring less than 20 mm might be believed to be less aggressive and indolent behavior than Lung-RADS–positive cancer cases. But it cannot be assumed that most or all of these are indolent over a long clinical course, and it is unclear what impact of these ones on lung cancer mortality rates. Recent studies have found that the nodules are more likely to be invasive adenocarcinomas when pure GGNs are greater than 15 mm in diameter with nodularity or have high pixel attenuation (> −472 HU)[3, 4]. Therefore we could have the potential to differentiate invasive adenocarcinoma from AIS or MIA according to the size and attenuation of pure GGN. This may potentially result in delay diagnosis or misleading with clinical physician according to the current version of Lung-RADS classification. Revised Lung-RADS classification system could be reasonably to expected in the future, and it should take into consideration in integration with the lung reporting and data system (LU-RADS) developed in Canada by Manos et al [5]. In addition, further studies are needed to establish appropriate surgical or biopsy time point for pure GGN and management strategies to allow successful implementation of lung cancer screening programs.
1. Pinsky Paul F., Gierada David S., Black William, Munden Reginald, Nath Hrudaya, Aberle Denise, Kazerooni Ella. Performance of Lung-RADS in the National Lung Screening TrialA Retrospective AssessmentPerformance of Lung-RADS in the NLST. Annals of Internal Medicine 2015;162: 485-491.
2. Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening. New England Journal of Medicine 2011;365: 395-409.
3. Lim Hyun-ju, Ahn Soomin, Lee Kyung Soo, Han Joungho, Shim Young Mog, Woo Sookyoung, Kim Jae-Hun, Yie Miyeon, Lee Ho Yun, Yi Chin A. Persistent pure ground-glass opacity lung nodules ≥ 10 mm in diameter at ct scan: Histopathologic comparisons and prognostic implications. Chest 2013;144: 1291-1299.
4. Lee Ho Yun, Choi Yoon-La, Lee Kyung Soo, Han Joungho, Zo Jae Ill, Shim Young Mog, Moon Jung Won. Pure Ground-Glass Opacity Neoplastic Lung Nodules: Histopathology, Imaging, and Management. American Journal of Roentgenology 2014;202: W224-W233.
5. Manos Daria, Seely Jean M., Taylor Jana, Borgaonkar Joy, Roberts Heidi C., Mayo John R. The Lung Reporting and Data System (LU-RADS): A Proposal for Computed Tomography Screening. Canadian Association of Radiologists Journal 2014;65: 121-134.