The results of 2 studies exploring adjuvant immune checkpoint inhibition (aCPI) in high-risk muscle-invasive urothelial cancer have yielded conflicting results. A trial employing placebo as the control arm demonstrated a significant prolongation in disease-free survival (DFS) whereas a trial employing observation as the control arm (IMvigor010) demonstrated no prolongation in DFS with CPI. Here, the authors including HIP Investigator Dr. Meggang Yu aimed to estimate the aCPI benefit and to model the potential impact of informative censoring on trial results.
Survival data from 1518 patients was reconstructed from Kaplan-Meier curves. A network meta-analysis approach was used to estimate aCPI benefit through the restricted mean disease-free survival time (RMDFST). They found that Phase 3 trials comparing adjuvant therapies to observation are at risk for informative censoring that could potentially impact interpretation of study results.
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