Long-Term Follow-up Results of the DANTE Trial, a Randomized Study of Lung Cancer Screening with Spiral Computed Tomography

Maurizio Infante, Silvio Cavuto, Fabio R omano Lutman, Eliseo Passera, Maurizio Chiarenza, Giuseppe Chiesa, Giorgio Brambilla, Enzo Angeli, Giuseppe Aranzulla, Arturo Chiti, Marta Scorsetti, Pierina Navarria, Raffaele Cavina, Michele Ciccarelli, Massimo Roncalli, Anna Destro, Edoardo Bottoni, Emanuele Voulaz, Valentina Errico, Giorgio FerraroliGiovanna Finocchiaro, Luca Toschi, Armando Santoro, Marco Alloisio, DANTE Study Group

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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.

Original languageEnglish
Pages (from-to)1166-1175
Number of pages10
JournalAmerican Journal of Respiratory and Critical Care Medicine
Volume191
Issue number10
DOIs
Publication statusPublished - May 15 2015

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Spiral Computed Tomography
Early Detection of Cancer
Lung Neoplasms
Arm
Mortality
Thorax
X-Rays
Confidence Intervals
Safety Management
Sputum
Uncertainty
Cell Biology
Smoking
Technology
Lung
Incidence
Population

Keywords

  • early diagnosis
  • lung neoplasms
  • randomized controlled trial
  • screening
  • spiral computed tomography

ASJC Scopus subject areas

  • Medicine(all)

Cite this

@article{d36281b68f0f4797adb9b035668f943c,
title = "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",
author = "Maurizio Infante and Silvio Cavuto and Lutman, {Fabio R omano} and Eliseo Passera and Maurizio Chiarenza and Giuseppe Chiesa and Giorgio Brambilla and Enzo Angeli and Giuseppe Aranzulla and Arturo Chiti and Marta Scorsetti and Pierina Navarria and Raffaele Cavina and Michele Ciccarelli and Massimo Roncalli and Anna Destro and Edoardo Bottoni and Emanuele Voulaz and Valentina Errico and Giorgio Ferraroli and Giovanna Finocchiaro and Luca Toschi and Armando Santoro and Marco Alloisio and {DANTE Study Group}",
year = "2015",
month = "5",
day = "15",
doi = "10.1164/rccm.201408-1475OC",
language = "English",
volume = "191",
pages = "1166--1175",
journal = "American Journal of Respiratory and Critical Care Medicine",
issn = "1073-449X",
publisher = "American Thoracic Society - AJRCCM",
number = "10",

}

TY - JOUR

T1 - Long-Term Follow-up Results of the DANTE Trial, a Randomized Study of Lung Cancer Screening with Spiral Computed Tomography

AU - Infante, Maurizio

AU - Cavuto, Silvio

AU - Lutman, Fabio R omano

AU - Passera, Eliseo

AU - Chiarenza, Maurizio

AU - Chiesa, Giuseppe

AU - Brambilla, Giorgio

AU - Angeli, Enzo

AU - Aranzulla, Giuseppe

AU - Chiti, Arturo

AU - Scorsetti, Marta

AU - Navarria, Pierina

AU - Cavina, Raffaele

AU - Ciccarelli, Michele

AU - Roncalli, Massimo

AU - Destro, Anna

AU - Bottoni, Edoardo

AU - Voulaz, Emanuele

AU - Errico, Valentina

AU - Ferraroli, Giorgio

AU - Finocchiaro, Giovanna

AU - Toschi, Luca

AU - Santoro, Armando

AU - Alloisio, Marco

AU - DANTE Study Group

PY - 2015/5/15

Y1 - 2015/5/15

N2 - 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.

AB - 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.

KW - early diagnosis

KW - lung neoplasms

KW - randomized controlled trial

KW - screening

KW - spiral computed tomography

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U2 - 10.1164/rccm.201408-1475OC

DO - 10.1164/rccm.201408-1475OC

M3 - Article

C2 - 25760561

AN - SCOPUS:84938514714

VL - 191

SP - 1166

EP - 1175

JO - American Journal of Respiratory and Critical Care Medicine

JF - American Journal of Respiratory and Critical Care Medicine

SN - 1073-449X

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