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Five year mortality in an RCT of a lung cancer biomarker to select people for low dose CT screening.

PloS one2025-01-08PubMed
Total: 78.5Innovation: 8Impact: 8Rigor: 8Citation: 7

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