• Maurizio Infante, Fabio Romano Lutman, Silvio Cavuto, Giorgio Brambilla, Giuseppe Chiesa, Eliseo Passera, Enzo Angeli, Maurizio Chiarenza, Giuseppe Aranzulla, Umberto Cariboni, Marco Alloisio, Matteo Incarbone, Alberto Testori, Anna Destro, Federico Cappuzzo, Massimo Roncalli, Armando Santoro, Gianluigi Ravasi, and DANTE Study Group.
• Thoracic Surgery Department, Istituto Clinico Humanitas, Rozzano, Milano, Italy. maurizio.infante@humanitas.it
• Lung Cancer. 2008 Mar 1;59(3):355-63.

BackgroundDespite the high survival rates reported for screening-detected cases, the potential of screening of high-risk subjects for reducing lung cancer mortality is still unproven. We herewith present the baseline results of a randomized trial comparing screening for lung cancer with annual spiral computed tomography (CT) versus a yearly clinical review.MethodsMale subjects, 60-74 years old, and smokers of 20+ pack-years were enrolled. All participants received a baseline medical examination, chest X-rays (CXR) and sputum cytology upon accrual. Subjects randomized in the spiral CT group received a spiral CT scan at baseline, then yearly for the following 4 years. For controls, a yearly clinical examination was scheduled for the following 4 years.Results2472 subjects were randomized (1276 spiral CT arm, 1196 controls). Age, smoking exposure and co-morbid conditions were similar in the two groups. In the spiral CT group, 28 lung cancers were detected, 13 of which were visible in the baseline chest X-rays (overall prevalence 2.2%). Sixteen out of 28 tumours (57%) were stage I, and 19 (68%) were resectable. In the control group, eight cases were detected by the baseline chest X-rays (prevalence rate 0.67%), four (50%) were stage I, and six (75%) were resectable.ConclusionsBaseline lung cancer detection rate in the spiral CT arm was higher than in most published studies. The stage I detection rate was increased four-fold by spiral CT versus chest X-rays. However, more tumours in an advanced stage were also detected by CT. The high resection rate of screening-detected patients suggests a possible increase in cure rate. However, longer follow-up is required for definitive conclusions. This trial has been registered at www.Clinicaltrials.gov, registration No. NCT00420862.

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