Lung cancer screening with spiral CT: baseline results of the randomized DANTE trial

Lung Cancer. 2008 Mar;59(3):355-63. doi: 10.1016/j.lungcan.2007.08.040. Epub 2007 Oct 23.


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, registration No. NCT00420862.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Humans
  • Incidence
  • Italy / epidemiology
  • Lung Neoplasms / diagnostic imaging*
  • Lung Neoplasms / epidemiology
  • Lung Neoplasms / therapy
  • Male
  • Mass Screening / methods
  • Middle Aged
  • Prevalence
  • Prospective Studies
  • Smoking / adverse effects
  • Survival Rate
  • Tomography, Spiral Computed*

Associated data