AS REPORTED in The Lancet Oncology by Matthijs Oudkerk, MD, of the University of Groningen, the Netherlands, and colleagues, a European Union (EU) expert group has issued a position statement on low-dose computed tomography (CT) screening for lung cancer, proposing a near-term phased implementation of screening in high-risk regions within 18 months and extension to all regions in Europe within 48 months.1
The EU position statement expert group consists of individuals from eight European countries who are active in the planning and execution of European randomized controlled screening trials; involved in clinical management of patients with lung cancer and lung nodules; and active in the development of clinical practice guidelines on smoking cessation and recruitment of high-risk participants, CT screening protocols, CT scan radiology reporting, and clinical management of CT-detected nodules. These experts constitute the core membership of the EU Lung Cancer CT Screening Implementation Group.
Rationale for Statement and Program Implementation
THE POSITION STATEMENT is restricted to lung cancer screening with low-dose CT and the early detection of lung nodules before clinical workup; it does not discuss the entirety of workup or treatment choices. As noted by the authors, since new randomized controlled trials of low-dose CT screening powered to permit conclusions on mortality reduction are not likely to be performed, the position statement recommendations are based on currently available data.
“As lung cancer screening is still in an embryonic stage of implementation in Europe, we have an opportunity to plan the development of an optimal lung cancer low-dose CT screening strategy.”— Matthijs Oudkerk, MD, and colleagues
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As stated by the authors, “Lung cancer screening with low-dose CT can save lives, and this method will probably be embraced by national health organizations throughout Europe in the future. The results from the U.S. National Lung Cancer Screening Trial (NLST) on reduced lung cancer mortality and from seven pilot trials 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 trial are awaited.” The NELSON trial is the only European randomized controlled trial designed to provide mortality and cost-effectiveness data.
Recommendations for Implementing Programs
THE POSITION STATEMENT provides a detailed review of diagnostic tests for lung cancer detection, outcomes of screening trials, risk prediction modeling, harms and benefits associated with screening, CT methodologies for early cancer detection, prerequisites for population screening, nodule management at baseline CT screening, incident screening rounds, workup of CT-detected lung nodules in clinical practice, and optimal timing of screening intervals. Detailed recommendations are provided on management of lung nodules by lung cancer multidisciplinary teams, with the objective of minimizing patient harm and ensuring that patients receive optimal diagnosis and therapy.
The expert group recommendations to begin implementation of screening in Europe are reproduced/summarized here:
- Low-dose CT is the only evidence-based method for early detection of lung cancer shown to provide a mortality reduction. On the basis of this evidence from randomized controlled trials, it is recommended that implementation of lung cancer screening in Europe be started while remaining cognizant of future publications that include the awaited NELSON trial data on mortality and cost-effectiveness and data from the six smaller European studies for developing implementation strategies in each of their own countries.
- Future lung cancer low-dose CT programs should use a validated risk stratification approach so only individuals deemed to be at high enough risk are screened. In the near future, incorporation of potential biomarkers and susceptibility genes into lung cancer risk models should be considered to improve the accuracy of risk stratification models.
- All future screenees entering into early detection programs for lung cancer should be provided with carefully constructed participant information on the potential benefits and harms of screening to enable them to make an informed decision as to whether they wish to participate or not. Smoking cessation advice should be offered to all active smokers.
- Future management of screen-detected solid nodules should use semiautomatically derived volume measurements and volume-doubling time and should be quality assured.
- National quality assurance boards should be set up to ensure adherence to all minimum technical standards, including semiautomated volumetry, and to standardize diagnostic criteria for screen-detected lung nodules, including radiation exposure limits.
- Management of prevalent lung nodules in CT screening programs, lung nodules at incident screening (newly detected), and CT-detected lung nodules in clinical practice should be managed with different protocols because of different pretest lung cancer probabilities.
- Although evidence for only annual low-dose CT lung cancer screening is available, recent research suggests the possibility of employing a more personalized approach to screening using a risk-based approach based on the results of baseline and first screening rounds.
- Management of lung nodules by lung cancer multidisciplinary teams should be performed according to the EU position statement recommendations, with the aim of minimizing harm and ensuring that patients receive the most appropriate treatment.
- The EU position statement expert group recommends that planning for low-dose CT screening should be started throughout Europe because such screening has the potential to save lives.
Implementation Timeline
THE PROPOSED TIMELINE for implementation of low-dose CT screening throughout Europe follows:
- Publish recommendations for implementation with quality assurance measures: 6 months
- Plan health service requirements and their delivery: 12 months
- Plan phased implementation in high-risk regions while awaiting mortality data from the NELSON trial: 18 months
- Plan to set up a European registry of images and data: 18 months
- Evaluate screening implementation after the first 12 months and review delivery strategy: 36 months
- Expand lung cancer screening to all regions within Europe: 48 months.
The authors noted that during the planning period, each country must focus on selecting the best risk prediction method for identification and recruitment of high-risk populations and on developing the required infrastructure for quality-controlled CT scans that use volumetric analysis.
Minimizing Harms of Screening
HARMS ASSOCIATED with lung cancer screening include overdiagnosis, surgery for benign lesions, psychological harm, and radiation exposure. The authors stress that these harms need to be acceptable before screening is implemented and that minimizing harm is essential to optimizing the effectiveness of screening. To this end, they maintain that a high degree of clinical expertise must be available in screening programs to ensure all aspects of screening and management are completed to the highest standards and that screening should be performed only according to defined protocols and at sites that can guarantee rigorous quality control.
The authors state: “In the future, we think that, with [eventual] implementation of ultra–low-dose CT screening, there will be no obstacles in tailoring the frequency of screening of high-risk individuals over a 25-year period. We should be considering precision medicine in the field of lung cancer screening and whether an individual who has had a negative baseline and a negative 1-year scan should be moved into biennial screening until [his or her] risk profile changes. As lung cancer screening is still in an embryonic stage of implementation in Europe, we have an opportunity to plan the development of an optimal lung cancer low-dose CT screening strategy.” ■
DISCLOSURE: For full disclosures of the study authors, visit www.thelancet.com.
REFERENCE
1. Oudkerk M, Devaraj A, Vliegenthart R, et al: European position statement on lung cancer screening. Lancet Oncol 18:e754-e766, 2017.
