Occurrence and lung cancer probability of new solid nodules at incidence screening with low-dose CT: analysis of data from the randomised, controlled NELSON trial (original) (raw)
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The Lancet. Oncology, 2014
The main challenge in CT screening for lung cancer is the high prevalence of pulmonary nodules and the relatively low incidence of lung cancer. Management protocols use thresholds for nodule size and growth rate to determine which nodules require additional diagnostic procedures, but these should be based on individuals' probabilities of developing lung cancer. In this prespecified analysis, using data from the NELSON CT screening trial, we aimed to quantify how nodule diameter, volume, and volume doubling time affect the probability of developing lung cancer within 2 years of a CT scan, and to propose and evaluate thresholds for management protocols. Eligible participants in the NELSON trial were those aged 50-75 years, who have smoked 15 cigarettes or more per day for more than 25 years, or ten cigarettes or more for more than 30 years and were still smoking, or had stopped smoking less than 10 years ago. Participants were randomly assigned to low-dose CT screening at increasi...
Persisting new nodules in incidence rounds of the NELSON CT lung cancer screening study
Thorax
BackgroundThe US guidelines recommend low-dose CT (LDCT) lung cancer screening for high-risk individuals. New solid nodules after baseline screening are common and have a high lung cancer probability. Currently, no evidence exists concerning the risk stratification of non-resolving new solid nodules at first LDCT screening after initial detection.MethodsIn the Dutch-Belgian Randomized Lung Cancer Screening (NELSON) trial, 7295 participants underwent the second and 6922 participants the third screening round. We included participants with solid nodules that were registered as new or <15 mm³ (study detection limit) at previous screens and received additional screening after initial detection, thereby excluding high-risk nodules according to the NELSON management protocol (nodules ≥500 mm3).ResultsOverall, 680 participants with 1020 low-risk and intermediate-risk new solid nodules were included. A total of 562 (55%) new solid nodules were resolving, leaving 356 (52%) participants wi...
Lung cancer (Amsterdam, Netherlands), 2018
New nodules are regularly found after the baseline round of low-dose computed tomography (LDCT) lung cancer screening. The relationship between a participant's number of new nodules and lung cancer probability is unknown. Participants of the ongoing Dutch-Belgian Randomized Lung Cancer Screening (NELSON) Trial with (sub)solid nodules detected after baseline and registered as new by the NELSON radiologists were included. The correlation between a participant's new nodule count and the largest new nodule size was assessed using Spearman's rank correlation. To evaluate the new nodule count as predictor for new nodule lung cancer together with largest new nodule size, a multivariable logistic regression analysis was performed. In total, 705 participants with 964 new nodules were included. In 48% (336/705) of participants no nodule had been found previously during baseline screening and in 22% (154/705) of participants >1 new nodule was detected (range 1-12 new nodules). E...
The Danish randomized lung cancer CT screening trial. Results at baseline
Journal of Thoracic Oncology, 2007
Introduction: Lung cancer screening with low dose computed tomography (CT) has not yet been evaluated in randomized clinical trials, although several are underway. Methods: In The Danish Lung Cancer Screening Trial, 4104 smokers and previous smokers from 2004 to 2006 were randomized to either screening with annual low dose CT scans for 5 years or no screening. A history of cigarette smoking of at least 20 pack years was required. All participants have annual lung function tests, and questionnaires regarding health status, psychosocial consequences of screening, smoking habits, and smoking cessation.
Thorax, 2018
New nodules after baseline are regularly found in low-dose CT lung cancer screening and have a high lung cancer probability. It is unknown whether morphological and location characteristics can improve new nodule risk stratification by size. Solid non-calcified nodules detected during incidence screening rounds of the randomised controlled Dutch-Belgian lung cancer screening (NELSON) trial and registered as new or previously below detection limit (15 mm) were included. A multivariate logistic regression analysis with lung cancer as outcome was performed, including previously established volume cut-offs (<30 mm, 30-<200 mm and ≥200 mm) and nodule characteristics (location, distribution, shape, margin and visibility <15 mm in retrospect). Overall, 1280 new nodules were included with 73 (6%) being lung cancer. Of nodules ≥30 mm at detection and visible <15 mm in retrospect, 22% (6/27) were lung cancer. Discrimination based on volume cut-offs (area under the receiver operati...
Results of the Randomized Danish Lung Cancer Screening Trial with Focus on High-Risk Profiling
American Journal of Respiratory and Critical Care Medicine, 2016
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. Clinical trial registered with www.clinicaltrials.gov (NCT00496977).
Thorax
BackgroundEstimation of the clinical probability of malignancy in patients with pulmonary nodules will facilitate early diagnosis, determine optimum patient management strategies and reduce overall costs.MethodsData from the UK Lung Cancer Screening trial were analysed. Multivariable logistic regression models were used to identify independent predictors and to develop a parsimonious model to estimate the probability of lung cancer in lung nodules detected at baseline and at 3-month and 12-month repeat screening.ResultsOf 1994 participants who underwent CT scan, 1013 participants had a total of 5063 lung nodules and 52 (2.6%) of the participants developed lung cancer during a median follow-up of 4 years. Covariates that predict lung cancer in our model included female gender, asthma, bronchitis, asbestos exposure, history of cancer, early and late onset of family history of lung cancer, smoking duration, FVC, nodule type (pure ground-glass and part-solid) and volume as measured by s...
Nodule management protocol of the NELSON randomised lung cancer screening trial
Lung Cancer, 2006
In December 2003, the Dutch-Belgian NELSON trial, a Dutch acronym for ''Nederlands-Leuvens Longkanker Screenings ONderzoek'', has been launched. Primary objective of the NELSON trial is to investigate whether screening for lung cancer by 16-detector multi-slice CT with 16 mm × 0.75 mm collimation and 15 mm table feed per rotation (pitch = 1.5) in year 1, 2 and 4 will lead to a decrease in lung cancer mortality in high risk subjects of at least 25% compared to a control group which receives no screening. In this paper, the screening regimen and the classification and management of the screen-detected nodules at baseline and incidence screening is presented. This is the first large lung cancer screening trial in which the Abbreviations: BAC, bronchiolo-alveolar cell carcinoma; MDCT, multi-detector computed tomography; ELCAP, Early Lung Cancer Action Project; FNA, fine needle aspirate; GROWCAT, nodule category based on VDT; MaxDiamXY, maximum diameter in X/Y-axis; MaxDiamZ, maximum diameter in Z-axis; NCN, non-calcified nodule; NELSON, ''Nederlands Leuvens Longkanker Screeningsonderzoek'' = Dutch-Belgian lung cancer screening trial; NMS, Nelson management system; NODCAT, nodule category based on size; PACS, picture archiving communication system; PerpdiamXY, maximum diameter perpendicular to maximum diameter in X/Y-axis; PET, positron emission tomography; PVC, percentage volume change; VATS, video assisted thoracic surgery; VDT, volume doubling time et al.
Thorax, 2012
Background The effects of low-dose CT screening on disease stage shift, mortality and overdiagnosis are unclear. Lung cancer findings and mortality rates are reported at the end of screening in the Danish Lung Cancer Screening Trial. Methods 4104 men and women, healthy heavy smokers/former smokers were randomised to five annual low-dose CT screenings or no screening. Two experienced chest radiologists read all CT scans and registered the location, size and morphology of nodules. Nodules between 5 and 15 mm without benign characteristics were rescanned after 3 months. Growing nodules (>25% volume increase and/or volume doubling time<400 days) and nodules >15 mm were referred for diagnostic workup. In the control group, lung cancers were diagnosed and treated outside the study by the usual clinical practice. Results Participation rates were high in both groups (screening: 95.5%; control: 93.0%; p<0.001). Lung cancer detection rate was 0.83% at baseline and mean annual detection rate was 0.67% at incidence rounds (p¼0.535). More lung cancers were diagnosed in the screening group (69 vs 24, p<0.001), and more were low stage (48 vs 21 stage IeIIB non-small cell lung cancer (NSCLC) and limited stage small cell lung cancer (SCLC), p¼0.002), whereas frequencies of high-stage lung cancer were the same (21 vs 16 stage IIIAeIV NSCLC and extensive stage SCLC, p¼0.509). At the end of screening, 61 patients died in the screening group and 42 in the control group (p¼0.059). 15 and 11 died of lung cancer, respectively (p¼0.428). Conclusion CT screening for lung cancer brings forward early disease, and at this point no stage shift or reduction in mortality was observed. More lung cancers were diagnosed in the screening group, indicating some degree of overdiagnosis and need for longer follow-up.