Baseline Findings of a Randomized Feasibility Trial of Lung Cancer Screening With Spiral CT Scan vs Chest Radiograph: The Lung Screening Study of the National Cancer Institute

doi:10.1378/chest.126.1.114

Chest

Volume 126, Issue 1, July 2004, Pages 114-121

https://doi.org/10.1378/chest.126.1.114 Get rights and content

Background:

Low-radiation-dose spiral CT (LDCT) scanning is capable of detecting lung neoplasms in asymptomatic individuals. To determine whether such detection can reduce lung cancer mortality, a randomized controlled trial (RCT) of LDCT scanning is necessary.

Methods:

The feasibility of conducting an RCT in asymptomatic individuals who are at high risk for lung cancer was explored in the Lung Screening Study (LSS), a 12-month special project of the ongoing Prostate, Lung, Colorectal, and Ovarian (PLCO) cancer screening trial. During the fall of 2000, six PLCO screening centers recruited a total of 3,318 heavy or long-term smokers who were not participants in the PLCO trial and randomized them to receive either a screening LDCT scan (1,660 participants) or screening posteroanterior view chest radiograph (CXR) [1,658 participants].

Results:

The screens were completed on 96% of subjects in the LDCT scan arm and 93% of subjects in the CXR arm. A total of 20.5% of screened subjects in the LDCT scan arm and 9.8% of those in the CXR arm had findings that were suspicious for lung cancer. Thirty lung cancers in subjects in the LDCT arm and 7 lung cancers in patients in the CXR arm were diagnosed following a positive screening result. Additional data from the LSS indicated that, among persons who were at elevated risk for lung cancer, CT scan use was not pervasive, interest in participating in an RCT of LDCT scanning was strong, and few subjects randomized to CXR either refused their examination or sought a CT scan after their study CXR.

Interpretation:

The results of the LSS demonstrated convincingly the feasibility of an RCT of LDCT scanning in the United States.

Section snippets

Materials and Methods

The LSS began as a 1-year special project of the PLCO cancer trial.⁷ The PLCO cancer trial provided an established infrastructure, resulting in an acceleration of LSS activities and rapid data collection. The following 6 of 10 PLCO screening centers were chosen, in a competitive fashion, to participate in the LSS: Georgetown University Medical Center/Lombardi Cancer Center (Washington, DC); Henry Ford Health System (Detroit, MI); Marshfield Medical Research and Education Foundation (Marshfield,

Recruitment and Randomization

Figure 1shows the Consolidated Standards of Reporting Trials (or CONSORT)¹¹ flow diagram for the trial. The six LSS screening centers mailed 653,417 information packages, beginning approximately September 1, 2000. Eligibility was assessed for the 12,270 persons who contacted a screening center. Of these, 4,828 persons (39%) were deemed to be eligible. Only a small number of participants (148; 1.2%) were ineligible due to having undergone a spiral CT scan examination in the previous 24 months.

Discussion

The LSS demonstrated convincingly the feasibility of an RCT of lung cancer screening with LDCT scanning. Substantial enrollment and minimal crossover contamination provide compelling evidence that randomization was acceptable to persons who were at elevated risk for lung cancer and that background use of LDCT scanning among these individuals was quite low. Furthermore, the LSS demonstrated that accrual could be accomplished at a rate rapid enough to ensure that a definitive trial could be

Appendix: Members of the Lung Screening Study Research Group

Susan Ascher, William Bailey, Brenda Brewer, Timothy Church, Deborah Engelhard, Richard Fagerstrom, Mona Fouad, Matthew Freedman, Edward Gelmann, John Gohagan, William Hocking, Subbarao Inampudi, Brian Irons, Christine Cole Johnson, Arthur Jones, Barnett Kramer, Gena Kucera, Paul Kvale, Karen Lappe, Lisa McFarland, William Manor, Pamela Marous, Alisha Moore, Hrudaya Nath, Sarah Neff, Martin Oken, Paul Pirsky, Michael Plunkett, Helen Price, Philip Prorok, Douglas Reding, Thomas Riley, Martin

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^†: A complete list of the Lung Screening Study Research Group is located in the ^Appendix.

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Chest

Clinical InvestigationsLUNG CANCERBaseline Findings of a Randomized Feasibility Trial of Lung Cancer Screening With Spiral CT Scan vs Chest Radiograph: The Lung Screening Study of the National Cancer Institute

Background:

Methods:

Results:

Interpretation:

Section snippets

Materials and Methods

Recruitment and Randomization

Discussion

Appendix: Members of the Lung Screening Study Research Group

Chest

Lancet

Lancet

Acad Radiol

Annual report to the nation on the status of cancer (1973–1998), featuring cancers with recent increasing trends

J Natl Cancer Inst

Primary prevention, smoking, and smoking cessation: implications for future trends in lung cancer prevention

Cancer

Early lung cancer detection: results of the initial (prevalence) radiologic and cytologic screening in the Johns Hopkins study

Am Rev Respir Dis

Clinical Investigations
LUNG CANCER
Baseline Findings of a Randomized Feasibility Trial of Lung Cancer Screening With Spiral CT Scan vs Chest Radiograph: The Lung Screening Study of the National Cancer Institute