Original Investigation |

Overdiagnosis in Low-Dose Computed Tomography Screening for Lung Cancer

Edward F. Patz Jr, MD1,2; Paul Pinsky, PhD3; Constantine Gatsonis, PhD4,5; JoRean D. Sicks, MS4; Barnett S. Kramer, MD, MPH3; Martin C. Tammemägi, PhD6; Caroline Chiles, MD7; William C. Black, MD8,9; Denise R. Aberle, MD10; for the NLST Overdiagnosis Manuscript Writing Team
[+] Author Affiliations
1Department of Radiology, Duke University Medical Center, Durham, North Carolina
2Department of Pharmacology and Cancer Biology, Duke University Medical Center, Durham, North Carolina
3Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland
4Center for Statistical Sciences, Brown School of Public Health, Providence, Rhode Island
5Department of Biostatistics, Brown School of Public Health, Providence, Rhode Island
6Department of Community Health Sciences, Brock University, St Catharines, Ontario, Canada
7Department of Radiology, Wake Forest University Health Sciences Center, Winston-Salem, North Carolina
8Department of Radiology, Dartmouth Medical School, Hanover, New Hampshire
9Department of Community and Family Medicine, Dartmouth Medical School, Hanover, New Hampshire
10Department of Radiology, University of California, Los Angeles
JAMA Intern Med. 2014;174(2):269-274. doi:10.1001/jamainternmed.2013.12738.
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Importance  Screening for lung cancer has the potential to reduce mortality, but in addition to detecting aggressive tumors, screening will also detect indolent tumors that otherwise may not cause clinical symptoms. These overdiagnosis cases represent an important potential harm of screening because they incur additional cost, anxiety, and morbidity associated with cancer treatment.

Objective  To estimate overdiagnosis in the National Lung Screening Trial (NLST).

Design, Setting, and Participants  We used data from the NLST, a randomized trial comparing screening using low-dose computed tomography (LDCT) vs chest radiography (CXR) among 53 452 persons at high risk for lung cancer observed for 6.4 years, to estimate the excess number of lung cancers in the LDCT arm of the NLST compared with the CXR arm.

Main Outcomes and Measures  We calculated 2 measures of overdiagnosis: the probability that a lung cancer detected by screening with LDCT is an overdiagnosis (PS), defined as the excess lung cancers detected by LDCT divided by all lung cancers detected by screening in the LDCT arm; and the number of cases that were considered overdiagnosis relative to the number of persons needed to screen to prevent 1 death from lung cancer.

Results  During follow-up, 1089 lung cancers were reported in the LDCT arm and 969 in the CXR arm of the NLST. The probability is 18.5% (95% CI, 5.4%-30.6%) that any lung cancer detected by screening with LDCT was an overdiagnosis, 22.5% (95% CI, 9.7%-34.3%) that a non–small cell lung cancer detected by LDCT was an overdiagnosis, and 78.9% (95% CI, 62.2%-93.5%) that a bronchioalveolar lung cancer detected by LDCT was an overdiagnosis. The number of cases of overdiagnosis found among the 320 participants who would need to be screened in the NLST to prevent 1 death from lung cancer was 1.38.

Conclusions and Relevance  More than 18% of all lung cancers detected by LDCT in the NLST seem to be indolent, and overdiagnosis should be considered when describing the risks of LDCT screening for lung cancer.

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Submit a Comment
Assumptions in LDCT screening Overdiagnosis Prediction Flawed
Posted on December 15, 2013
Andrea Borondy Kitts
Lung Cancer Advocate and MPH Student
Conflict of Interest: None Declared
After reading the JAMA paper, as an engineer, I am amazed it was peer reviewed and published. The assumption, that all of the additional lung cancers found by LDCT scans over those found by CXR are over diagnosis, is flawed. If that were true, there would not have been a difference in mortality between the screening arms. The NLST only did 3 screens, 1 prevalence screen followed by 2 annual incidence screens. Lung cancers found with LDCT screening were 70% Stage 1 and 2 and 30% Stage 3 and 4. The extra cancers found by LDCTarm vs CXR arm were essentially all of the early stage ones. Follow-up cancers found post screening in the LDCT screening arm reverted back to 37% early stage and 63% late stage. (The National Lung Screening Trial Research Team . N Engl J Med 2011;365:395-409). To assume that the early stage lung cancers found with LDCT screening were all over diagnosis conflicts with the 20% reduction in mortality achieved with LDCT scans. The early stage lung cancers are the most curable ones and constitute the reduction in mortality. Also of interest is that at least one of the authors, William J. Patz, has an undisclosed conflict of interest. He is the author of 5 patents on an alternate method for lung cancer screening. http://patents.justia.com/inventor/edward-f-patz. Could this conflict of interest have influenced his analysis and methodology? Please consider retracting this paper from JAMA. It is hurting not only your reputation but also the perceptions on LDCT scan lung cancer screening in the medical community and the general population.
Notice of Correction
Posted on March 27, 2014
Michael Berkwits, MD, MSCE
Electronic Media Editor, JAMA
Conflict of Interest: None Declared
In response to the above comment, the online Conflict of Interest Statement of this article, which read \"Conflict of Interest Disclosures: None\" was replaced on March 10 with the the following: \"Conflict of Interest Disclosures: Dr Patz conducted a research project on serum protein biomarkers and indeterminate pulmonary nodules funded by Laboratory Corporation of American through a sponsored research agreement with Duke University. Dr. Gatsonis is a consultant/member of the scientific advisory board for Wilex AG and a board member for Frontier Science and Technology Research Foundation and has served as a consultant to Endocyte Inc and Genentech.\" A formal correction will be issued in an upcoming print issue.
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