The National Lung Screening Trial: Overview and Study Design

Aberle, Denise R.; Berg, Christine D.; Church, Timothy R.; Fagerstrom, Richard M.; Galen, Barbara; Gareen, Ilana F.; Gohagan, John K.; Hillman, Bruce J.; Jaffe, C. Carl; Kramer, Barnett S.; Lynch, David A.; Marcus, Pamela M.; Schnall, Mitchell D.; Sullivan, Daniel C.; Sullivan, Dorothy; Cagnon, Christopher H.; Cody, Dianna D.; Fletcher, Glenn G; Judy, Philip F.; Kruger, Randell; Larke, Frederick J.; McNitt‐Gray, Michael F.; Seibert, J. Anthony; Wu, Xizeng; Abbott, Gerald F.; Amorosa, Judith K.; Boiselle, Phillip M.; Chiles, Caroline; Clark, Robert A.; Coppage, Lynn; Falk, Robert; Fishman, Elliot K.; Gemmel, David; Goldin, Jonathan G.; Goodman, Eric T.; Hart, Eric; Hazelton, Todd R.; Kazerooni, Ella A.; McComb, Barbara L.; McLennan, Geoffrey; Ravenel, James G.; Swensen, Stephen J.; Balkin, Peter; Freedman, Matthew T.; Garg, Kavita D.; Gelmann, Edward P.; Gierada, David S.; Hocking, William G.; Inampudi, Subbarao; Isaacs, Claudine; Kvale, Paul A.; Mann, Howard; Manor, William; Nath, Hrudaya; Reding, Douglas J.; Chen, Mei-Hsiu; Duan, Fenghai; Izmirilian, Grant; Pinsky, Paul F.; Prorok, Philip C.; Miller, Anthony B.; Edelman, Martin J.; Evans, William K.; Fontana, Robert S.; Machtay, Mitchell; Clingan, Kathy L.; Ford, Melissa; Márquez, Guillermo; Moore, Steven M.; Ohan, Peter; Payne, Thomas J.; Peace, Steven; Rosenbaum, Jennifer; Barr, Richard G.; Black, William C.; Torigian, Drew A.; Vydareny, Kay H.; Worrell, John A.; Young, Robert C.; Alberts, David S.; DeMets, David L.; Greenwald, Peter; Jacobs, Paula; McLoud, Theresa C.; Naidich, David P.; Tatum, James L.; Sausville, Edward A.; Burke, Wylie; Colice, Gene; Edwards, Brenda K.; Emerson, Scott S.; Fletcher, John; Green, Sylvan; Russell, Helen; Klein, Jeffrey S.; Korn, Edward L.; Mayer, Robert J.; Selby, Joe V.; Sturges, David W.; Turnbull, Bruce W.; Watson, Thomas J.; Baylin, Stephen B.; Caporaso, Neil E.; Dennis, Philip A.; Dubinett, Steven M.; Franklin, Wilbur A.; Grizzle, William; Hirsch, Fred R.; Massion, Pierre P.; McKeeta-Frobeck, Kathy; Minna, John D.; Patz, Edward F.; Spitz, Margaret R.; Berg, Christine B.; Corle, Donald K.; Hu, Ping; Izmirlian, Grant; Gaegler, Jennifer; Hoffman, Susan A.; Jackson, Charles T.; Lange, Erin O.; Papadopoulos, Evanthia; Gatsonis, Constantine; Gareen, Iiana; Apgar, Charles; Boyle, Anna; Caldwell, Tom; Fredericks, Nancy; Harbison, Deborah; Hartfeil, Donna; Jones, Sharon; King, Steve; Mahon, Irene; Medina, Rosa; Masiejczyk, Cindy; Zamora, Peter; Brastater, Hank; Iyer, V.; George, Jincy; Gopalakrishnan, Dinakar; Blair, Patricia D.; Bradley, Michael J.; Crozier, C.; Oh, Maria; Spiese, Nicole; Steward, Chris; Kelly-Truran, Mary; Thompson, Tess; Cunningham, Erin; Levering, Anthony; McMurtrie, Kathleen; Nahill, Michael; Snowden, S; Smith, Kesha; Wilton, Fraser; Welsh, Timothy N.; Welsh, Rex; Christie, Wendell; Clabo, Stephanie; Clune, Roberta; Cunningham, Natalie; Downs, J. 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doi:10.1148/radiol.10091808

Cited by 996 publications

(464 citation statements)

References 38 publications

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“…Details of the NLST study design and methods for classifiying lung nodules have been published (8–10). Briefly, Participants were randomly assigned to undergo three annual screenings with either LDCT (N = 26,722) or chest radiography (N= 26,732) (8–10).…”

Section: Methodsmentioning

confidence: 99%

Radiologic Features of Small Pulmonary Nodules and Lung Cancer Risk in the National Lung Screening Trial: A Nested Case-Control Study

Liu¹,

Wang²,

Li³

et al. 2018

Radiology

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Purpose Using data and images from the National Lung Screening Trial (NLST), we extracted radiological features from small pulmonary nodules (SPNs) that did not meet the original criteria to be considered a positive screen and identified features associated with lung cancer risk. Methods We extracted radiological features from SPNs of baseline low-dose computed tomography screens that did not meet NLST criteria to be considered a positive screen. SPNs were identified for 73 incidence case patients that were diagnosed with lung cancer at either the first or second follow-up screen and for 157 control subjects who had had three consecutive negative screens. Multivariable logistic regression was used to assess the association between radiological features and lung cancer risk. All statistical tests were two-sided. Results Nine features were significantly different between case patients and control subjects. Backward-elimination followed by bootstrap re-sampling identified a reduced model of highly informative radiological features with an under the ROC curve of 0.932 (95% C] 0.88–0.96), specificity of 92.38% (95% CI 52.22–84.91), and sensitivity of 76.55% (95% CI 87.50–95.35) that included total emphysema score (OR=1.71; 95% CI 1.39–2.01), attachment to vessel (OR=2.41; 95% CI 0.99–5.81), nodule location (OR=3.25; 95% CI 1.09–8.55), border definition (OR=7.56; 95% CI 1.89–30.8), and concavity (OR=2.58; 95% CI 0.89–5.64). Conclusion We identified a set of clinically relevant radiological features that that can be easily scored in the clinical setting and may be of use to determine lung cancer risk among participants presenting with SPNs.

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Section: Methodsmentioning

confidence: 99%

Radiologic Features of Small Pulmonary Nodules and Lung Cancer Risk in the National Lung Screening Trial: A Nested Case-Control Study

Liu¹,

Wang²,

Li³

et al. 2018

Radiology

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“…To date, only one trial (NLST 35 ) has demonstrated a reduction in mortality from CT screening, 49 but even when the results of NLST are combined with the three European trials that have reported on mortality (ITALUNG, 41 MILD, 38 DLCST…”

Section: Lung Cancer Screening In Clinical Practice In the Ukmentioning

confidence: 99%

The UK Lung Cancer Screening Trial: a pilot randomised controlled trial of low-dose computed tomography screening for the early detection of lung cancer

Field

Duffy

Baldwin

et al. 2016

Health Technol Assess

234

231

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BackgroundLung cancer kills more people than any other cancer in the UK (5-year survival < 13%). Early diagnosis can save lives. The USA-based National Lung Cancer Screening Trial reported a 20% relative reduction in lung cancer mortality and 6.7% all-cause mortality in low-dose computed tomography (LDCT)-screened subjects.ObjectivesTo (1) analyse LDCT lung cancer screening in a high-risk UK population, determine optimum recruitment, screening, reading and care pathway strategies; and (2) assess the psychological consequences and the health-economic implications of screening.DesignA pilot randomised controlled trial comparing intervention with usual care. A population-based risk questionnaire identified individuals who were at high risk of developing lung cancer (≥ 5% over 5 years).SettingThoracic centres with expertise in lung cancer imaging, respiratory medicine, pathology and surgery: Liverpool Heart & Chest Hospital, Merseyside, and Papworth Hospital, Cambridgeshire.ParticipantsIndividuals aged 50–75 years, at high risk of lung cancer, in the primary care trusts adjacent to the centres.InterventionsA thoracic LDCT scan. Follow-up computed tomography (CT) scans as per protocol. Referral to multidisciplinary team clinics was determined by nodule size criteria.Main outcome measuresPopulation-based recruitment based on risk stratification; management of the trial through web-based database; optimal characteristics of CT scan readers (radiologists vs. radiographers); characterisation of CT-detected nodules utilising volumetric analysis; prevalence of lung cancer at baseline; sociodemographic factors affecting participation; psychosocial measures (cancer distress, anxiety, depression, decision satisfaction); and cost-effectiveness modelling.ResultsA total of 247,354 individuals were approached to take part in the trial; 30.7% responded positively to the screening invitation. Recruitment of participants resulted in 2028 in the CT arm and 2027 in the control arm. A total of 1994 participants underwent CT scanning: 42 participants (2.1%) were diagnosed with lung cancer; 36 out of 42 (85.7%) of the screen-detected cancers were identified as stage 1 or 2, and 35 (83.3%) underwent surgical resection as their primary treatment. Lung cancer was more common in the lowest socioeconomic group. Short-term adverse psychosocial consequences were observed in participants who were randomised to the intervention arm and in those who had a major lung abnormality detected, but these differences were modest and temporary. Rollout of screening as a service or design of a full trial would need to address issues of outreach. The health-economic analysis suggests that the intervention could be cost-effective but this needs to be confirmed using data on actual lung cancer mortality.ConclusionsThe UK Lung Cancer Screening (UKLS) pilot was successfully undertaken with 4055 randomised individuals. The data from the UKLS provide evidence that adds to existing data to suggest that lung cancer screening in the UK could potentially be implemented in the 60–75 years age group, selected via the Liverpool Lung Project risk model version 2 and using CT volumetry-based management protocols.Future workThe UKLS data will be pooled with the NELSON (Nederlands Leuvens Longkanker Screenings Onderzoek: Dutch–Belgian Randomised Lung Cancer Screening Trial) and other European Union trials in 2017 which will provide European mortality and cost-effectiveness data. For now, there is a clear need for mortality results from other trials and further research to identify optimal methods of implementation and delivery. Strategies for increasing uptake and providing support for underserved groups will be key to implementation.Trial registrationCurrent Controlled Trials ISRCTN78513845.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 40. See the NIHR Journals Library website for further project information.

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“…Several lung cancer screening trials using low-dose CT showed that malignant tumours can be detected at an earlier stage than by clinical assessment. [35][36][37][38][39] However, these trials were not controlled in design and therefore effect on mortality is difficult to determine. In addition, these studies showed high false positive rates and low rates of detection of incident cases of lung cancer.…”

Section: Chest X-ray and Computed Tomography Screeningmentioning

confidence: 99%

“…The last round of screening was carried out in 2007 and an overview report has been published this year. 39 Smaller European studies have reported preliminary results on prevalence of lung cancer at baseline screening but have yet to complete. 40,41 Screening programmes are not without inherent difficulties, some of which are specific to lung cancer.…”

Section: Chest X-ray and Computed Tomography Screeningmentioning

confidence: 99%

Advances in the prevention and treatment of lung cancer

Sethi²

2011

J R Coll Physicians Edinb

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Lung cancer remains the most common fatal malignancy in the Western world. Survival rates have only improved modestly over the past three decades and new approaches are urgently required. It is clear that a concerted effort to reduce cigarette smoking is required. However, about 10% of patients with lung cancer are never smokers, indicating genetic or other predisposition. Lung cancer screening programmes are being trialled to target high-risk populations. Genetic strategies will provide new methods for screening and predicting response to treatment. Current therapy for lung cancer has reached a plateau and novel agents have shown modest clinical efficacy. Understanding the mechanisms by which chronic inflammatory disorders such as chronic obstructive pulmonary disease contribute to lung cancer development will help to identify new biological targets and biomarkers of early disease. This review focuses on recent advances in lung cancer prevention and treatment.

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The National Lung Screening Trial: Overview and Study Design

Cited by 996 publications

References 38 publications

Radiologic Features of Small Pulmonary Nodules and Lung Cancer Risk in the National Lung Screening Trial: A Nested Case-Control Study

Radiologic Features of Small Pulmonary Nodules and Lung Cancer Risk in the National Lung Screening Trial: A Nested Case-Control Study

The UK Lung Cancer Screening Trial: a pilot randomised controlled trial of low-dose computed tomography screening for the early detection of lung cancer

Advances in the prevention and treatment of lung cancer

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