Performance of Lung-RADS in the National Lung Screening Trial

A Retrospective Assessment

Pinsky, Paul F. PhD
Gierada, David S. MD
Black, William MD
Munden, Reginald MD
Nath, Hrudaya MD
Aberle, Denise MD
Kazerooni, Ella MD

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, [email protected]). 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, [email protected].

Current author addresses and author contributions are available at www.annals.org.

For author affiliations, see end of text.

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

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.

Annals of Internal Medicine 162(7):p 485-491, April 7, 2015.

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.