With 338,000 EU-deaths annually, lung cancer is a devastating problem. CT screening has the potential to prevent ten-thousands of lung cancer deaths annually. The positive results of the Dutch-Belgian screening trial (NELSON), with relatively low referral rates, and the NLST in the US, with annual screens only, provided conclusive evidence on the benefits (and possible harms). However, EU-implementation is likely to be limited, slow and of variable quality throughout European countries, and current international guidelines could easily require up to 25 million CT screens annually. The most optimal strategy in risk-based lung-thoracic screening is still unknown regarding the optimal and most cost-effective (e.g. targeted) strategy 1) to recruit high-risk individuals, 2) to integrate smoking cessation and co-morbidity-reducing services, and 3) to determine the preferred personalised (risk-based) screening interval. Personalised regimens based on the baseline CT result can potentially retain 85% of the LC mortality reduction achievable through screening at 45% less screens, thus potentially saving much unnecessary harm associated with screening, and 0.5-1 billion Euros per year.
The heart of 4-IN-THE-LUNG-RUN is a European randomised controlled multi-centred implementation trial amongst 20,054 individuals, at high risk for developing lung cancer, evaluating whether it is safe to have risk-based less intensive screening intervals after a negative baseline CT.
Various methods to improve participation of hard-to-reach individuals will be assessed in five different healthcare settings/countires. Innovative co-morbidity reducing strategies will be tested including other markers on CT imaging, as Calcium Score and COPD. Cost impact and cost-effectiveness analyses using a natural history model will steer implementation. The experienced consortium will strongly interact with key stakeholders, and discuss interim results with key other international initiatives on CT screening, biomarkers, and smoking cessation practices. This proposal will form the evidence base for risk-based lung cancer screening with huge benefits for the EU, on health outcomes, cost savings, and innovation in the long run.
