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Observational, One-Arm Studies and Randomized Population-Based Trials for Evaluation of the Efficacy of Lung Cancer Screening

In 1999, the Early Lung Cancer Action Project (ELCAP) published the results of its evaluation of early detection of lung cancer in high-risk subjects in New York, showing that low-dose computed tomography (CT) is a sensitive tool for the identification of non-calcified pulmonary nodules and early lung cancer.1 A methodological debate then ensued over the need to demonstrate by means of a randomized controlled trial (RCT) the reduction of lung cancer mortality for people included in CT scan screening versus those unscreened or screened by chest radiograph. In their recent article, the International ELCAP group (I-ELCAP) has confirmed (with a greater number of cases) that CT scan is a sensitive screening test for early lung cancer and has shown high survival rates among patients with stage I screen-detected disease.2 Several other one-arm studies evaluating the screening test at prevalence and incidence screening have confirmed its good performance.3,4