Screening with chest radiography did not reduce lung cancer mortality in older patients

Randomized controlled trial (Prostate, Lung, Colorectal, and Ovarian [PLCO] Cancer Screening Trial). ClinicalTrials.gov NCT00002540.

Unclear allocation concealment.*

Blinded* (cause of death adjudicators).

Up to 13 years (mean 11.2 y). In October 2010, the data safety monitoring board recommended reporting endpoint results because they deemed additional follow-up to be unnecessary.

10 screening centers in the USA.

154 901 adults 55 to 74 years of age (50% women; 45% never-smokers, 10% current smokers). Exclusion criteria included history of prostate, lung, colorectal, or ovarian cancer; current cancer treatment; and removal of 1 lung.

Posterior–anterior chest radiography at baseline and then annually for 3 years (n = 77 445) or usual care (n = 77 456). Some never-smokers in the intervention group were not offered the year 3 screen; patients with positive results on a chest radiograph (a nodule, mass, infiltrate, or other abnormality suspicious for cancer) were advised to seek diagnostic evaluation.

Lung cancer mortality. Secondary outcomes included lung cancer incidence; mortality from causes other than prostate, lung, colorectal, or ovarian cancer; and complications from diagnostic procedures related to screening. Mortality was detected by active follow-up and linkage to the National Death Index. The trial would have had 90% power to detect a 10% reduction in lung cancer mortality with 3796 lung cancer deaths.

99% (intention-to-screen analysis).