PURPOSE: To assess the possibility of reducing lung cancer mortality in a high risk population. Lung Cancer (LC) incidence, prevalence, stage at presentation, resectability and survival are secondary endpoints. A set of specific genetic abnormalities in blood and sputum is also being assessed.
METHODS: Inclusion Criteria were: male sex, age 60-75, smokers of 20+ pack-years, quit less than 10 yrs ago. Subjects were randomized in two groups: LDCT Screening or Control (Ctrl). On accrual, all subjects underwent a baseline physical examination, and once-only Chest X-ray (CXR) and sputum cytologic examination. Screening-arm subjects have then undergone yearly LDCT while controls get yearly interview/physical examination only and investigation upon clinical suspicion.
RESULTS: From June 2001 to February 2006, 2472 cases (LDCT 1276, Ctrls 1196) were randomized. Age, smoking and comorbidities are evenly distributed. 40% have had at least one follow-up examination.Baseline screening by CXR/Sputum cytology revealed lung cancer in 21 patients. First-year LDCT revealed 12 LCs. 9 LDCT patients (2 interval cases ) and 13 Controls developed LC during follow-up.More LCs and more Stage I LC have been detected in the LDCT group, while resection rates are similar. Non-LC malignancies were detected in 3,06 % of LDCT and in 1,92% of Controls.So far, 8 (0,63%) LDCT and 6 (0,50%) Ctrl patients have died of lung cancer, while 14 (1.1%) LDCT and 11 (0.92%) Ctrl patients have died of competing causes of death.
CONCLUSION: DANTE has shown the feasibility of a randomized LDCT screening trial with no intervention in the control arm. Baseline screening results are in agreement with the LSS baseline data. Mortality figures are still too small to be meaningful.
CLINICAL IMPLICATIONS: The potential advantages of LDCT screening for reducing lung cancer mortality must be weighted against health resources burden, screening-related morbidity, and competing causes of death. Disease–specific mortality reduction should be assessed in large randomised trials. Follow-up in the DANTE trial is still open and ongoing.
DISCLOSURE: Maurizio Infante, None.