Results of the Randomized Danish Lung Cancer Screening Trial with Focus on High-Risk Profiling

TY - JOUR

T1 - Results of the Randomized Danish Lung Cancer Screening Trial with Focus on High-Risk Profiling

AU - M. W. Wille, Mathilde

AU - Dirksen, Asger

AU - Ashraf, Haseem

AU - Saghir, Zaigham

AU - Bach, Karen Skjøldstrup

AU - Brodersen, John

AU - Clementsen, Paul F

AU - Hansen, Hanne

AU - Larsen, Klaus R

AU - Mortensen, Jann

AU - Rasmussen, Jakob F

AU - Seersholm, Niels

AU - Skov, Birgit G

AU - Thomsen, Laura

AU - Tønnesen, Philip

AU - Pedersen, Jesper H.

PY - 2016/3/1

Y1 - 2016/3/1

N2 - Rationale: As of April 2015, participants in the Danish Lung Cancer Screening Trial had been followed for at least 5 years since their last screening. Objectives: Mortality, causes of death, and lung cancer findings are reported to explore the effect of computed tomography (CT) screening. Methods: A total of 4,104 participants aged 50-70 years at the time of inclusion and with a minimum 20 pack-years of smoking were randomized to have five annual low-dose CT scans (study group) or no screening (control group). Measurements and Main Results: Follow-up information regarding date and cause of death, lung cancer diagnosis, cancer stage, and histology was obtained from national registries. No differences between the two groups in lung cancer mortality (hazard ratio, 1.03; 95% confidence interval, 0.66-1.6; P = 0.888) or all-cause mortality (hazard ratio, 1.02; 95% confidence interval, 0.82-1.27; P = 0.867) were observed. More cancers were found in the screening group than in the no-screening group (100 vs. 53, respectively; P,0.001), particularly adenocarcinomas (58 vs. 18, respectively; P,0.001). More early-stage cancers (stages I and II, 54 vs. 10, respectively; P, 0.001) and stage IIIa cancers (15 vs. 3, respectively; P = 0.009) were found in the screening group than in the control group. Stage IV cancers were nonsignificantly more frequent in the control group than in the screening group (32 vs. 23, respectively; P = 0.278). For the highest-stage cancers (T4N3M1, 21 vs. 8, respectively; P = 0.025), this difference was statistically significant, indicating an absolute stage shift. Older participants, those with chronic obstructive pulmonary disease, and those with more than 35 pack-years of smoking had a significantly increased risk of death due to lung cancer, with nonsignificantly fewer deaths in the screening group. Conclusions: No statistically significant effects of CT screening on lung cancer mortality were found, but the results of post hoc high-risk subgroup analyses showed nonsignificant trends that seem to be in good agreement with the results of the National Lung Screening Trial.

AB - Rationale: As of April 2015, participants in the Danish Lung Cancer Screening Trial had been followed for at least 5 years since their last screening. Objectives: Mortality, causes of death, and lung cancer findings are reported to explore the effect of computed tomography (CT) screening. Methods: A total of 4,104 participants aged 50-70 years at the time of inclusion and with a minimum 20 pack-years of smoking were randomized to have five annual low-dose CT scans (study group) or no screening (control group). Measurements and Main Results: Follow-up information regarding date and cause of death, lung cancer diagnosis, cancer stage, and histology was obtained from national registries. No differences between the two groups in lung cancer mortality (hazard ratio, 1.03; 95% confidence interval, 0.66-1.6; P = 0.888) or all-cause mortality (hazard ratio, 1.02; 95% confidence interval, 0.82-1.27; P = 0.867) were observed. More cancers were found in the screening group than in the no-screening group (100 vs. 53, respectively; P,0.001), particularly adenocarcinomas (58 vs. 18, respectively; P,0.001). More early-stage cancers (stages I and II, 54 vs. 10, respectively; P, 0.001) and stage IIIa cancers (15 vs. 3, respectively; P = 0.009) were found in the screening group than in the control group. Stage IV cancers were nonsignificantly more frequent in the control group than in the screening group (32 vs. 23, respectively; P = 0.278). For the highest-stage cancers (T4N3M1, 21 vs. 8, respectively; P = 0.025), this difference was statistically significant, indicating an absolute stage shift. Older participants, those with chronic obstructive pulmonary disease, and those with more than 35 pack-years of smoking had a significantly increased risk of death due to lung cancer, with nonsignificantly fewer deaths in the screening group. Conclusions: No statistically significant effects of CT screening on lung cancer mortality were found, but the results of post hoc high-risk subgroup analyses showed nonsignificant trends that seem to be in good agreement with the results of the National Lung Screening Trial.

U2 - 10.1164/rccm.201505-1040OC

DO - 10.1164/rccm.201505-1040OC

M3 - Journal article

C2 - 26485620

SN - 1073-449X

VL - 193

SP - 542

EP - 551

JO - American Journal of Respiratory and Critical Care Medicine

JF - American Journal of Respiratory and Critical Care Medicine

IS - 5

ER -