Data for this European Union position statement were identified through searches of PubMed, MEDLINE, and references from relevant articles using search terms “lung cancer CT screening trial”, “lung screen detected nodules”, “lung cancer CT screening recommendations”, and “lung cancer CT screening cost effectiveness”. Identified abstracts and reports from meetings were included only when they related directly to previously published work. Only articles published in English between 1999 and 2017
Policy ReviewEuropean position statement on lung cancer screening
Introduction
Lung cancer screening with low-dose CT can save lives, and this method will probably be embraced by national health organisations throughout Europe in the future. The results from the US National Lung Cancer Screening Trial (NLST)1 on reduced lung cancer mortality and from seven pilot trials2, 3, 4, 5, 6, 7, 8 within Europe on other aspects of low-dose CT screening have provided sufficient evidence for Europe to start planning for lung cancer screening while mortality data from the NELSON trial2 are awaited.
This European Union (EU) position statement describes the current status of lung cancer screening and sets out the essential elements needed to ensure the development of effective European screening programmes. The EU position statement expert group comprises individuals from eight European countries who have been actively engaged in the planning and execution of randomised controlled screening trials in Europe,9 who are involved in the clinical management of patients with lung cancer and lung nodules, and who have developed relevant clinical practice guidelines on smoking cessation, recruitment of high risk participants, patient information literature, as well as CT screening protocols, CT scan radiology reporting, and the clinical management of CT-detected nodules. These experts represent all the specialties and professions involved in delivering successful lung cancer screening programmes in Europe. The emphasis of this EU position statement focuses on the actual implementation of CT lung cancer screening programmes in Europe by radiologists, supported by epidemiologists, pulmonologists, and thoracic surgeons, in the full context of clinical lung cancer diagnosis and treatment. These individuals comprise the core membership of the EU Lung cancer CT Screening Implementation Group (EU-LSIG) and have prepared this EU position statement. We did a comprehensive literature search for papers on lung cancer screening and, through in-depth discussions, developed this EU position statement consensus.
The structure of this document not only reflects the available evidence that addresses the major questions concerning the delivery of a successful screening intervention, but also highlights any issues that still need to be resolved for successful implementation. Contributions to this EU position statement were provided by a team of clinicians and scientists expert in CT as the method of choice for lung cancer screening. The requirement for an EU position statement stems from the need to provide European recommendations on CT screening that will assist the EU Commission and national health agencies in beginning to plan the implementation of lung cancer screening within the next 2 years, and to avoid opportunistic and uncontrolled screening. Moreover, since the publication of the NLST results in 2011,1 an EU position statement on the value of CT screening for lung cancer is now a crucial necessity.
The focus of this EU position statement is restricted to lung cancer screening with low-dose CT and the early detection of lung nodules before clinical work-up, and does not address the entirety of work-up and treatment choices. Since new randomised controlled trials of low-dose CT screening that are powered to allow conclusions about mortality reduction are highly unlikely, our recommendations are based on the current available data. Data provided by several studies2, 6, 8 are sufficient to make recommendations concerning the minimisation of false positive results in both screen-detected and non-screen detected nodules. The need for non-contrast-enhanced low-dose interval imaging should not be considered a false-positive test because the individual is not undergoing an invasive clinical work-up and therefore the risk of physical harm is very low. Furthermore, evidence10, 11 shows that the psychological distress caused is transient and smoking cessation rates increase among those who require interval imaging.
This position statement represents a balance of the available data and therefore reflects which approaches are supported by good evidence, where further evidence is needed to implement effective screening programmes, and where practical implications for lung cancer screening can already be drawn from the available knowledge.
Section snippets
Diagnostic tests for lung cancer detection
CT has progressed to be the best method for lung cancer screening. Previous lung cancer screening trials in the 1980s using chest x-rays with and without sputum cytology showed no significant survival advantage,12, 13 which led to inactivity in this field of research for more than two decades. The first publication on lung CT screening in 199914 ignited interest in this field again. Other diagnostic methods might have a future potential in lung cancer screening but no trials are yet available
Outcomes of lung cancer screening trials
The outcomes of various lung cancer screening trials provide insight into how to implement lung cancer screening in differing countries in Europe, as well as the optimal set-up for a population and screening at a single centre. We have learnt much about each stage of the lung cancer CT screening pathway and the management decisions that are required.22 Ongoing trials2, 3, 4, 5, 6, 7, 8 have provided insight into risk assessment, CT screen nodule management, multidisciplinary team work-up, and
Lung cancer risk prediction modelling
The concept of clearly defining a target population for lung cancer screening is gaining importance.19, 27 Selection on the basis of age alone, as in most other cancer screening disease settings (eg, breast and colon), is insufficient in lung cancer because of other powerful risk factors, the most important of which is exposure to tobacco smoke. Other major risk factors, which are also taken into account, include a history of respiratory diseases (COPD, emphysema, bronchitis, pneumonia, and
Harms and benefits associated with lung cancer screening
The harms associated with lung cancer screening, such as overdiagnosis, surgery for benign lesions, psychological harm, and radiation exposure, need to be acceptable before the implementation of screening. Minimising harm is essential to maximise the clinical effectiveness of the intervention.
Physical harms can be reduced by ensuring that only patients with a sufficiently high risk of developing lung cancer are screened, by reducing screening radiation dose to a minimum, and by the effective
CT methodologies for early lung cancer detection
In the NLST trial, a CT screen was regarded as positive if it showed any non-calcified nodule of at least 4 mm in diameter. The American College of Radiology set up a Lung Cancer Screening Committee subgroup to develop Lung-RADS,51, 52 a quality assurance tool with which to standardise the reporting of lung cancer CT screening and to inform management recommendations. The rationale behind this initiative was that it would assist in the interpretation of nodule findings.
A comparison of Lung-RADS
Prerequisites for lung cancer population screening
The accreditation awarded to institutions and radiologists participating in lung cancer CT screenings should include training in the implementation of quality assurance processes.
The establishment of central national registries for participants would ensure that inclusion criteria are met. In this registry, results from different screening modalities, such as CT manufacturer dose, together with work-up results, should be collected to ensure that previous screens are available and quality
Lung nodule management at baseline CT screening
The management of prevalent lung nodules should mostly depend on size criteria. Volumetry is essential, but diameter cutoffs need to be provided for cases in which segmentation is not possible. Minimum standards for CT acquisition parameters in lung cancer screening need to be met to ensure the standardisation of volumetric analysis (ie, protocol regarding slice thickness, reconstruction interval, and image reconstruction algorithm [kernel]), and to clearly define the low radiation dose.
The
Incident screening rounds
Although incident screening rounds will constitute much of the work in the early detection of lung cancer, until recently research did not focus on incident nodules and their definition, which has varied widely between low-dose CT lung cancer screening trials.8, 64, 69, 70 Incident nodules detected in high-risk individuals after baseline screening had either been missed in a previous scan or had developed de novo in the time interval since the previous scan. In the event of a missed nodule,
Clinical work-up of CT-detected lung nodules in clinical practice
Incidentally detected lung nodules are an increasingly common clinical problem arising from the increased use of cross-sectional imaging in clinical practice. The BTS has undertaken the in-depth task of developing guidelines on the management of pulmonary nodules in a clinical context, separate from the context of population screening.64 This work has been based on an extensive review of the literature, which included publications from several lung cancer CT screening trials, and an in-depth
Optimal timing of lung cancer screening intervals
The USPSTF on CT screening has recommended annual screening from age 55 years to 80 years.80 In a NELSON publication,81 a 2·5-year screening interval resulted in a significant increase in interval cancers in the fourth screening round, providing evidence against using this interval in a future screening programme. There were also significantly more interval cancers in a 2·5-year timeframe, and a trend towards more cancers detected at a later stage. A detailed analysis of the cost-effectiveness
Conclusion
This EU position statement describes the current status of lung cancer screening in Europe. Through consensus discussions with experts from the eight European countries undertaking randomised controlled trials of lung cancer CT screening, we have developed nine recommendations to guide the implementation of lung cancer screening in Europe (panel 1). Some specific areas still require further development and consideration, such as the integratation of smoking cessation into lung cancer screening
Search strategy and selection criteria
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