Five year mortality in an RCT of a lung cancer biomarker to select people for low dose CT screening.
Summary
In a pragmatic RCT of 12,208 high-risk adults, biomarker-guided selection (EarlyCDT-Lung) for LDCT screening was associated with reduced lung cancer mortality at 5 years (adjusted HR 0.789), with stronger benefits among cancers diagnosed within two years of randomization.
Key Findings
- Biomarker-guided arm had fewer lung cancer deaths at 5 years (adjusted HR 0.789; 95% CI 0.636–0.978).
- Among cancers diagnosed within 2 years, all-cause mortality HR 0.615 and lung cancer mortality HR 0.598 favored biomarker-guided selection.
- Randomized 12,208 high-risk adults; outcomes ascertained via death and cancer registries in a pragmatic design.
Clinical Implications
Health systems could integrate blood-based autoantibody testing to triage LDCT eligibility, potentially improving screening efficiency and reducing mortality in high-risk populations.
Why It Matters
Provides rare randomized evidence that biomarker-guided, risk-targeted screening can improve survival, informing precision screening strategies beyond age/pack-year criteria.
Limitations
- Open-label screening strategy; potential differences in downstream management
- Generalizability and cost-effectiveness in diverse healthcare systems require evaluation
Future Directions
Head-to-head comparisons with risk models, integration with polygenic and clinical risk, and cost-effectiveness and implementation studies in varied health systems.
Study Information
- Study Type
- RCT
- Research Domain
- Prevention
- Evidence Level
- I - Randomized controlled trial with mortality outcomes over 5 years
- Study Design
- OTHER