BACKGROUND: The National Lung Screening Trial was conducted to determine whether three annual screenings (rounds T0, T1, and T2) with low-dose helical computed tomography (CT), as compared with chest radiography, could reduce mortality from lung cancer. We present detailed findings from the first two incidence screenings (rounds T1 and T2). METHODS: We evaluated the rate of adherence of the participants to the screening protocol, the results of screening and downstream diagnostic tests, features of the lung-cancer cases, and first-line treatments, and we estimated the performance characteristics of both screening methods. RESULTS: At the T1 and T2 rounds, positive screening results were observed in 27.9% and 16.8% of participants in the low-dose CT group and in 6.2% and 5.0% of participants in the radiography group, respectively. In the low-dose CT group, the sensitivity was 94.4%, the specificity was 72.6%, the positive predictive value was 2.4%, and the negative predictive value was 99.9% at T1; at T2, the positive predictive value increased to 5.2%. In the radiography group, the sensitivity was 59.6%, the specificity was 94.1%, the positive predictive value was 4.4%, and the negative predictive value was 99.8% at T1; both the sensitivity and the positive predictive value increased at T2. Among lung cancers of known stage, 87 (47.5%) were stage IA and 57 (31.1%) were stage III or IV in the low-dose CT group at T1; in the radiography group, 31 (23.5%) were stage IA and 78 (59.1%) were stage III or IV at T1. These differences in stage distribution between groups persisted at T2. CONCLUSIONS: Low-dose CT was more sensitive in detecting early-stage lung cancers, but its measured positive predictive value was lower than that of radiography. As compared with radiography, the two annual incidence screenings with low-dose CT resulted in a decrease in the number of advanced-stage cancers diagnosed and an increase in the number of early-stage lung cancers diagnosed. (Funded by the National Cancer Institute; NLST ClinicalTrials.gov number, NCT00047385.).
RCT Entities:
BACKGROUND: The National Lung Screening Trial was conducted to determine whether three annual screenings (rounds T0, T1, and T2) with low-dose helical computed tomography (CT), as compared with chest radiography, could reduce mortality from lung cancer. We present detailed findings from the first two incidence screenings (rounds T1 and T2). METHODS: We evaluated the rate of adherence of the participants to the screening protocol, the results of screening and downstream diagnostic tests, features of the lung-cancer cases, and first-line treatments, and we estimated the performance characteristics of both screening methods. RESULTS: At the T1 and T2 rounds, positive screening results were observed in 27.9% and 16.8% of participants in the low-dose CT group and in 6.2% and 5.0% of participants in the radiography group, respectively. In the low-dose CT group, the sensitivity was 94.4%, the specificity was 72.6%, the positive predictive value was 2.4%, and the negative predictive value was 99.9% at T1; at T2, the positive predictive value increased to 5.2%. In the radiography group, the sensitivity was 59.6%, the specificity was 94.1%, the positive predictive value was 4.4%, and the negative predictive value was 99.8% at T1; both the sensitivity and the positive predictive value increased at T2. Among lung cancers of known stage, 87 (47.5%) were stage IA and 57 (31.1%) were stage III or IV in the low-dose CT group at T1; in the radiography group, 31 (23.5%) were stage IA and 78 (59.1%) were stage III or IV at T1. These differences in stage distribution between groups persisted at T2. CONCLUSIONS: Low-dose CT was more sensitive in detecting early-stage lung cancers, but its measured positive predictive value was lower than that of radiography. As compared with radiography, the two annual incidence screenings with low-dose CT resulted in a decrease in the number of advanced-stage cancers diagnosed and an increase in the number of early-stage lung cancers diagnosed. (Funded by the National Cancer Institute; NLST ClinicalTrials.gov number, NCT00047385.).
Authors: Pamela M Marcus; Ilana F Gareen; Anthony B Miller; Jennifer Rosenbaum; Kristen Keating; Denise R Aberle; Christine D Berg Journal: Contemp Clin Trials Date: 2011-07-18 Impact factor: 2.226
Authors: Rob J van Klaveren; Matthijs Oudkerk; Mathias Prokop; Ernst T Scholten; Kristiaan Nackaerts; Rene Vernhout; Carola A van Iersel; Karien A M van den Bergh; Susan van 't Westeinde; Carlijn van der Aalst; Erik Thunnissen; Dong Ming Xu; Ying Wang; Yingru Zhao; Hester A Gietema; Bart-Jan de Hoop; Harry J M Groen; Geertruida H de Bock; Peter van Ooijen; Carla Weenink; Johny Verschakelen; Jan-Willem J Lammers; Wim Timens; Dik Willebrand; Aryan Vink; Willem Mali; Harry J de Koning Journal: N Engl J Med Date: 2009-12-03 Impact factor: 91.245
Authors: Martin C Tammemägi; Hormuzd A Katki; William G Hocking; Timothy R Church; Neil Caporaso; Paul A Kvale; Anil K Chaturvedi; Gerard A Silvestri; Tom L Riley; John Commins; Christine D Berg Journal: N Engl J Med Date: 2013-02-21 Impact factor: 91.245
Authors: Denise R Aberle; Amanda M Adams; Christine D Berg; Jonathan D Clapp; Kathy L Clingan; Ilana F Gareen; David A Lynch; Pamela M Marcus; Paul F Pinsky Journal: J Natl Cancer Inst Date: 2010-11-22 Impact factor: 13.506
Authors: Timothy R Church; William C Black; Denise R Aberle; Christine D Berg; Kathy L Clingan; Fenghai Duan; Richard M Fagerstrom; Ilana F Gareen; David S Gierada; Gordon C Jones; Irene Mahon; Pamela M Marcus; JoRean D Sicks; Amanda Jain; Sarah Baum Journal: N Engl J Med Date: 2013-05-23 Impact factor: 91.245
Authors: Emily A DuComb; Benjamin A Tonelli; Ya Tuo; Bernard F Cole; Vitor Mori; Jason H T Bates; George R Washko; Raúl San José Estépar; C Matthew Kinsey Journal: Chest Date: 2020-06-26 Impact factor: 9.410
Authors: Paul F Pinsky; David S Gierada; William Black; Reginald Munden; Hrudaya Nath; Denise Aberle; Ella Kazerooni Journal: Ann Intern Med Date: 2015-04-07 Impact factor: 25.391
Authors: Edwin J R van Beek; Christiane Kuhl; Yoshimi Anzai; Patricia Desmond; Richard L Ehman; Qiyong Gong; Garry Gold; Vikas Gulani; Margaret Hall-Craggs; Tim Leiner; C C Tschoyoson Lim; James G Pipe; Scott Reeder; Caroline Reinhold; Marion Smits; Daniel K Sodickson; Clare Tempany; H Alberto Vargas; Meiyun Wang Journal: J Magn Reson Imaging Date: 2018-08-25 Impact factor: 4.813