Relationship between the number of new nodules and lung cancer probability in incidence screening rounds of CT lung cancer screening: The NELSON study (original) (raw)
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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...
The Lancet. Oncology, 2016
US guidelines now recommend lung cancer screening with low-dose CT for high-risk individuals. Reports of new nodules after baseline screening have been scarce and are inconsistent because of differences in definitions used. We aimed to identify the occurrence of new solid nodules and their probability of being lung cancer at incidence screening rounds in the Dutch-Belgian Randomized Lung Cancer Screening Trial (NELSON). In the ongoing, multicentre, randomised controlled NELSON trial, between Dec 23, 2003, and July 6, 2006, 15 822 participants who had smoked at least 15 cigarettes a day for more than 25 years or ten cigarettes a day for more than 30 years and were current smokers, or had quit smoking less than 10 years ago, were enrolled and randomly assigned to receive either screening with low-dose CT (n=7915) or no screening (n=7907). From Jan 28, 2004, to Dec 18, 2006, 7557 individuals underwent baseline screening with low-dose CT; 7295 participants underwent second and third scr...
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...
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...
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...
JNCI Journal of the National Cancer Institute, 2014
Background Computed tomography (CT) screening for lung cancer has been associated with a high frequency of false positive results because of the high prevalence of indeterminate but usually benign small pulmonary nodules. The acceptability of reducing false-positive rates and diagnostic evaluations by increasing the nodule size threshold for a positive screen depends on the projected balance between benefits and risks. Methods We examined data from the National Lung Screening Trial (NLST) to estimate screening CT performance and outcomes for scans with nodules above the 4 mm NLST threshold used to classify a CT screen as positive. Outcomes assessed included screening results, subsequent diagnostic tests performed, lung cancer histology and stage distribution, and lung cancer mortality. Sensitivity, specificity, positive predictive value, and negative predictive value were calculated for the different nodule size thresholds. All statistical tests were two-sided. Results In 64% of positive screens (11 598/18 141), the largest nodule was 7 mm or less in greatest transverse diameter. By increasing the threshold, the percentages of lung cancer diagnoses that would have been missed or delayed and false positives that would have been avoided progressively increased, for example from 1.0% and 15.8% at a 5 mm threshold to 10.5% and 65.8% at an 8 mm threshold, respectively. The projected reductions in postscreening follow-up CT scans and invasive procedures also increased as the threshold was raised. Differences across nodules sizes for lung cancer histology and stage distribution were small but statistically significant. There were no differences across nodule sizes in survival or mortality. Conclusion Raising the nodule size threshold for a positive screen would substantially reduce false-positive CT screenings and medical resource utilization with a variable impact on screening outcomes.
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.
European Radiology, 2015
Objectives To assess the risk of lung cancer and specific mortality rate in patients with and without solitary pulmonary nodules (SPN) on chest radiograph and CT. Methods This prospective study included 16,078 patients ≥35 years old (893 of them had an SPN detected with either chest radiograph or CT) and 15,185 without SPN. Patients were followed up for 18 months or until being diagnosed with lung cancer. Risk and mortality lung cancer were calculated in both groups with Poisson regression. Results In patients with SPN, incidence of lung cancer was 8.3 % (95 % CI 6.0-11.2) on radiograph and 12.4 % (95 % CI 9.3-15.9) on CT. A chronic obstructive pulmonary disease in patients with radiographs (odds ratio 2.62; 95 % CI 1.03, 6.67) and smoking habit (odds ratio 20.63; 95 % CI 3.84, 110.77) in patients with CT were associated with a higher probability of lung cancer. Large nodule size and spiculated edge were associated with lung cancer on both CT and radiograph. Lung cancer-specific mortality was lower in patients with SPN than in those without SPN (1.73/1000 person-years, 95 % CI 1.08-2.88 vs. 2.15/1000 person-years, 95 % CI 1.25-3.96). Conclusions The risk of lung cancer for patients with SPN is higher in clinical populations than in screening studies. Moreover, patients with SPN showed lower mortality than those without SPN. Key Points • Lung cancer risk is 8 % for SPN detected on routine radiographs. • Lung cancer risk is 12.4 % for SPN detected in routine chest CT. • Smoking, COPD, SPN diameter and edge were predictors of malignancy. • Lung cancer risk of SPN in routine practice seems higher than in screening.