To determine the efficacy of lung cancer screening with low-dose CT on LC mortality. LC prevalence, incidence, stage distribution, and resectability are secondary endpoints.To investigate the prevalence of a set of genetic mutations in sputum and blood samples of heavy smokers
2400 pts will be randomised and followed for at least 5 years. Inclusion criteria are male sex, age 60–75, smoking history of 20+ pack-years.On accrual, all subjects undergo clinical examination, Chest X-rays (CXR) and sputum cytology. Blood and sputum samples are also collected for genetic analyses. Screened subjects undergo immediate LDCT, repeated annually. Controls undergo yearly clinical examination. Positive CXR cases are screened out.
As of March 11, 2003, 786 subjects have been randomised. Their mean age is 65 and 60% are currently active smokers. Hypertension, COPD and cardiovascular diseases are the most prevalent comorbidities. Age distribution, comorbidities, and smoking history are comparable between the two groups. The preliminary results are summarized in Table 1
Preliminary results at two yearsBASELINELDCTCtrlsOverallN°414372786Pts with Non-Calcified Lesions45 (11%)Follow-up LDCTs12517FNABs437VATS415Open Biopsy202LC detected9 (2.17%)4 (1.01%)13Negative CXR5R0 resection6 (67%)3 (75%).1 LC patient in the screened group had negative LDCT but positive sputum examination.1 low-symptomatic esophageal cancer, one aspergilloma and one esophageal leiomyoma were incidentally diagnosed by LDCT.CONCLUSIONS: The workup of doubtful or suspicious lesions resulted in a more extensive use of semi-invasive or invasive investigations in the LDCT group. There have been more LC cases detected through LDCT than with CXR, but the numbers are still small. Accrual is ongoing.
Several LC screening programmes with LDCT are currently active and report on high rates of early-stage lung cancer detection. Concerns about possible biases influencing survival outcomes in uncontrolled studies, added morbidity due to follow-up investigations and health resources burden warrant further investigation through randomized controlled trials.
M.V. Infante, None.