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Performance of Lung-RADS in the National Lung Screening Trial: A Retrospective AssessmentPerformance of Lung-RADS in the NLST

Paul F. Pinsky, PhD; David S. Gierada, MD; William Black, MD; Reginald Munden, MD; Hrudaya Nath, MD; Denise Aberle, MD; and Ella Kazerooni, MD
[+] Article, Author, and Disclosure Information

This article was published online first at www.annals.org on 10 February 2015.

From National Cancer Institute, Bethesda, Maryland; Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, Missouri; Geisel School of Medicine at Dartmouth, Hanover, New Hampshire; Houston Methodist Hospital, Houston, Texas; University of Alabama at Birmingham, Birmingham, Alabama; David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California; and University of Michigan, Ann Arbor, Michigan.

Grant Support: The NLST was supported by the following grants and contracts: U01-CA-80098, U01-CA-79778, N01-CN-25522, N01-CN-25511, N01-CN-25512, N01-CN-25513, N01-CN-25514, N01-CN-25515, N01-CN-25516, N01-CN-25518, N01-CN-25524, N01-CN-75022, N01-CN-25476, and N02-CN-63300.

Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M14-2108.

Reproducible Research Statement:Study protocol and statistical code: Available from Dr. Pinsky (e-mail, pp4f@nih.gov). Data set: Available at https://biometry.nci.nih.gov/cdas.

Requests for Single Reprints: Paul F. Pinsky, PhD, National Cancer Institute, 9609 Medical Center Drive, Room 5E108, Bethesda, MD, 20892; e-mail, pp4f@nih.gov.

Current Author Addresses: Dr. Pinsky: National Cancer Institute, 9609 Medical Center Drive, Room 5E108, Bethesda, MD 20892.

Dr. Gierada: Washington University School of Medicine, 510 South Kingshighway Boulevard, St. Louis, MO 63110.

Dr. Black: Department of Radiology, Geisel School of Medicine at Dartmouth, 1 Rope Ferry Road, Hanover, NH 03755.

Dr. Munden: 6565 Fannin Street, Houston, TX 77030.

Dr. Nath: University of Alabama at Birmingham School of Medicine, 1720 2nd Avenue South, Birmingham, AL 35294.

Dr. Aberle: Department of Radiologic Sciences, David Geffen School of Medicine at University of California, Los Angeles, 924 Westwood Boulevard, Los Angeles, CA 90024.

Dr. Kazerooni: Department of Radiology, University of Michigan, 1500 East Medical Center Drive, Ann Arbor, MI 48109.

Author Contributions: Conception and design: P.F. Pinsky, W. Black, R. Munden, D. Aberle, E. Kazerooni.

Analysis and interpretation of the data: P.F. Pinsky, D.S. Gierada, W. Black, R. Munden, H. Nath, E. Kazerooni.

Drafting of the article: P.F. Pinsky, H. Nath.

Critical revision of the article for important intellectual content: P.F. Pinsky, D.S. Gierada, W. Black, R. Munden, H. Nath, D. Aberle, E. Kazerooni.

Final approval of the article: P.F. Pinsky, D.S. Gierada, W. Black, R. Munden, H. Nath, D. Aberle, E. Kazerooni.

Provision of study materials or patients: R. Munden, D. Aberle, E. Kazerooni.

Statistical expertise: P.F. Pinsky.Collection and assembly of data: R. Munden, E. Kazerooni.

Ann Intern Med. 2015;162(7):485-491. doi:10.7326/M14-2086
Text Size: A A A

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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Pure groundglass nodules: Controversial in Lung RADS category 2
Posted on May 4, 2015
Fu-Zong Wu, Ming-Ting Wu
Kaohsiung Veterans General Hospital
Conflict of Interest: None Declared
Pinsky et al. reported that Performance of Lung-RADS in the National Lung Screening Trial: A Retrospective Assessment. In this article, the lung cancer present rate at baseline for Lung-RADS category 2 was 19.2% (95% CI, 12.4% to 13.2%).
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.

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