UK Lung Cancer RCT Pilot Screening Trial: baseline findings from the screening arm provide evidence for the potential implementation of lung cancer screening

Background Lung cancer screening using low-dose CT (LDCT) was shown to reduce lung cancer mortality by 20% in the National Lung Screening Trial. Methods The pilot UK Lung Cancer Screening (UKLS) is a randomised controlled trial of LDCT screening for lung cancer versus usual care. A population-based questionnaire was used to identify high-risk individuals. CT screen-detected nodules were managed by a pre-specified protocol. Cost effectiveness was modelled with reference to the National Lung Cancer Screening Trial mortality reduction. Results 247 354 individuals aged 50–75 years were approached; 30.7% expressed an interest, 8729 (11.5%) were eligible and 4055 were randomised, 2028 into the CT arm (1994 underwent a CT). Forty-two participants (2.1%) had confirmed lung cancer, 34 (1.7%) at baseline and 8 (0.4%) at the 12-month scan. 28/42 (66.7%) had stage I disease, 36/42 (85.7%) had stage I or II disease. 35/42 (83.3%) had surgical resection. 536 subjects had nodules greater than 50 mm3 or 5 mm diameter and 41/536 were found to have lung cancer. One further cancer was detected by follow-up of nodules between 15 and 50 mm3 at 12 months. The baseline estimate for the incremental cost-effectiveness ratio of once-only CT screening, under the UKLS protocol, was £8466 per quality adjusted life year gained (CI £5542 to £12 569). Conclusions The UKLS pilot trial demonstrated that it is possible to detect lung cancer at an early stage and deliver potentially curative treatment in over 80% of cases. Health economic analysis suggests that the intervention would be cost effective—this needs to be confirmed using data on observed lung cancer mortality reduction. Trial registration ISRCTN 78513845.

[1]  Harry J de Koning,et al.  Lung cancer probability in patients with CT-detected pulmonary nodules: a prespecified analysis of data from the NELSON trial of low-dose CT screening. , 2014, The Lancet. Oncology.

[2]  S W Duffy,et al.  Clinical Studies , 1877, Journal of Psychological Medicine and Mental Pathology (London, England : 1875).

[3]  John K Field,et al.  CT screening for lung cancer: countdown to implementation. , 2013, The Lancet. Oncology.

[4]  B. E. Peterson [Diagnosis of lung cancer]. , 1971, Voprosy onkologii.

[5]  H. D. de Koning,et al.  Volumetric computed tomography screening for lung cancer: three rounds of the NELSON trial , 2013, European Respiratory Journal.

[6]  J. Habbema,et al.  Risk‐based selection from the general population in a screening trial: Selection criteria, recruitment and power for the Dutch‐Belgian randomised lung cancer multi‐slice CT screening trial (NELSON) , 2007, International journal of cancer.

[7]  Rongwei Fu,et al.  Screening for Lung Cancer With Low-Dose Computed Tomography: A Systematic Review to Update the U.S. Preventive Services Task Force Recommendation , 2013, Annals of Internal Medicine.

[8]  S. Duffy,et al.  Predictive Accuracy of the Liverpool Lung Project Risk Model for Stratifying Patients for Computed Tomography Screening for Lung Cancer , 2012, Annals of Internal Medicine.

[9]  H. D. de Koning,et al.  Characteristics of lung cancers detected by computer tomography screening in the randomized NELSON trial. , 2013, American journal of respiratory and critical care medicine.

[10]  H. Morgenstern,et al.  Systematic Reviews and Meta-and Pooled Analyses Previous Lung Diseases and Lung Cancer Risk : A Pooled Analysis From the International Lung Cancer Consortium , 2012 .

[11]  Harry J de Koning,et al.  Management of lung nodules detected by volume CT scanning. , 2009, The New England journal of medicine.

[12]  S. Duffy,et al.  Barriers to uptake among high-risk individuals declining participation in lung cancer screening: a mixed methods analysis of the UK Lung Cancer Screening (UKLS) trial , 2015, BMJ Open.

[13]  Arash Naeim,et al.  Cost-effectiveness of CT screening in the National Lung Screening Trial. , 2014, The New England journal of medicine.

[14]  C. Gatsonis,et al.  Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening , 2012 .

[15]  C. Berg,et al.  Targeting of low-dose CT screening according to the risk of lung-cancer death. , 2013, The New England journal of medicine.

[16]  M. L. R. D. Christenson,et al.  Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening , 2012 .

[17]  John K. Field,et al.  Perspective: The screening imperative , 2014, Nature.

[18]  H. D. de Koning,et al.  European randomized lung cancer screening trials: Post NLST , 2013, Journal of surgical oncology.

[19]  Matthijs Oudkerk,et al.  Prospects for population screening and diagnosis of lung cancer , 2013, The Lancet.

[20]  Alexander Rokitansky,et al.  Thorax , 2009, Pediatric Surgery Digest.

[21]  Matthijs Oudkerk,et al.  International Association for the Study of Lung Cancer Computed Tomography Screening Workshop 2011 report. , 2012, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[22]  John K Field,et al.  The UK Lung Screen (UKLS): Demographic Profile of First 88,897 Approaches Provides Recommendations for Population Screening , 2014, Cancer Prevention Research.

[23]  N J Wald,et al.  UK Lung Screen (UKLS) nodule management protocol: modelling of a single screen randomised controlled trial of low-dose CT screening for lung cancer , 2011, Thorax.