title: Lung cancer screening with spiral CT: baseline results of the randomized DANTE trial.
abstract: BACKGROUND
  Despite 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.
  
  
  METHODS
  Male 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.
  
  
  RESULTS
  2472 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.
  
  
  CONCLUSIONS
  Baseline 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.
authors.affiliation: Thoracic Surgery Department, Istituto Clinico Humanitas, Rozzano, Milano, Italy. maurizio.infante@humanitas.it
authors.forename: Maurizio
authors.initials: M
authors.lastname: Infante
authors.forename: Fabio Romano
authors.initials: FR
authors.lastname: Lutman
authors.forename: Silvio
authors.initials: S
authors.lastname: Cavuto
authors.forename: Giorgio
authors.initials: G
authors.lastname: Brambilla
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Chiesa
authors.forename: Eliseo
authors.initials: E
authors.lastname: Passera
authors.forename: Enzo
authors.initials: E
authors.lastname: Angeli
authors.forename: Maurizio
authors.initials: M
authors.lastname: Chiarenza
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Aranzulla
authors.forename: Umberto
authors.initials: U
authors.lastname: Cariboni
authors.forename: Marco
authors.initials: M
authors.lastname: Alloisio
authors.forename: Matteo
authors.initials: M
authors.lastname: Incarbone
authors.forename: Alberto
authors.initials: A
authors.lastname: Testori
authors.forename: Anna
authors.initials: A
authors.lastname: Destro
authors.forename: Federico
authors.initials: F
authors.lastname: Cappuzzo
authors.forename: Massimo
authors.initials: M
authors.lastname: Roncalli
authors.forename: Armando
authors.initials: A
authors.lastname: Santoro
authors.forename: Gianluigi
authors.initials: G
authors.lastname: Ravasi
mesh_terms: D000368:Aged; D006801:Humans; D015994:Incidence; D007558:Italy / Q000453:epidemiology; D008175:Lung Neoplasms / Q000000981:diagnostic imaging* / Q000453:epidemiology / Q000628:therapy; D008297:Male; D008403:Mass Screening / Q000379:methods; D008875:Middle Aged; D015995:Prevalence; D011446:Prospective Studies; D012907:Smoking / Q000009:adverse effects; D015996:Survival Rate; D036542:Tomography, Spiral Computed