Long-Term Follow-up Results of the DANTE Trial, a Randomized Study of Lung Cancer Screening with Spiral Computed Tomography
- PMID: 25760561
- DOI: 10.1164/rccm.201408-1475OC
Long-Term Follow-up Results of the DANTE Trial, a Randomized Study of Lung Cancer Screening with Spiral Computed Tomography
Abstract
Rationale: Screening for lung cancer with low-dose spiral computed tomography (LDCT) has been shown to reduce lung cancer mortality by 20% compared with screening with chest X-ray (CXR) in the National Lung Screening Trial, but uncertainty remains concerning the efficacy of LDCT screening in a community setting.
Objectives: To explore the effect of LDCT screening on lung cancer mortality compared with no screening. Secondary endpoints included incidence, stage, and resectability rates.
Methods: Male smokers of 20+ pack-years, aged 60 to 74 years, underwent a baseline CXR and sputum cytology examination and received five screening rounds with LDCT or a yearly clinical review only in a randomized fashion.
Measurements and main results: A total of 1,264 subjects were enrolled in the LDCT arm and 1,186 in the control arm. Their median age was 64.0 years (interquartile range, 5), and median smoking exposure was 45.0 pack-years. The median follow-up was 8.35 years. One hundred four patients (8.23%) were diagnosed with lung cancer in the screening arm (66 by CT), 47 of whom (3.71%) had stage I disease; 72 control patients (6.07%) were diagnosed with lung cancer, with 16 (1.35%) being stage I cases. Lung cancer mortality was 543 per 100,000 person-years (95% confidence interval, 413-700) in the LDCT arm versus 544 per 100,000 person-years (95% CI, 410-709) in the control arm (hazard ratio, 0.993; 95% confidence interval, 0.688-1.433).
Conclusions: Because of its limited statistical power, the results of the DANTE (Detection And screening of early lung cancer with Novel imaging TEchnology) trial do not allow us to make a definitive statement about the efficacy of LDCT screening. However, they underline the importance of obtaining additional data from randomized trials with intervention-free reference arms before the implementation of population screening.
Keywords: early diagnosis; lung neoplasms; randomized controlled trial; screening; spiral computed tomography.
Comment in
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Screening for Lung Cancer Using Low-Dose Computed Tomography. Are We Headed for DANTE's Paradise or Inferno?Am J Respir Crit Care Med. 2015 May 15;191(10):1100-1. doi: 10.1164/rccm.201503-0565ED. Am J Respir Crit Care Med. 2015. PMID: 25978569 No abstract available.
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Mortality Reduction, Overdiagnosis, and the Benefit-to-Harm Ratio of Computed Tomography Screening.Am J Respir Crit Care Med. 2015 Aug 1;192(3):398-9. doi: 10.1164/rccm.201504-0801LE. Am J Respir Crit Care Med. 2015. PMID: 26230243 No abstract available.
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Reply: Mortality Reduction, Overdiagnosis, and the Benefit-to-Harm Ratio of Computed Tomography Screening.Am J Respir Crit Care Med. 2015 Aug 1;192(3):399-400. doi: 10.1164/rccm.201505-0951LE. Am J Respir Crit Care Med. 2015. PMID: 26230244 No abstract available.
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