Progression-free survival and objective response rate as a surrogate end point for overall survival in metastatic renal cell carcinoma: A systematic review and meta-analysis.
Russell Leong, David Chen, Laith Almasri et al.
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In 30 seconds
This systematic review and meta-analysis evaluated the validity of progression-free survival (PFS) and objective response rate (ORR) as surrogate endpoints for overall survival (OS) in randomized controlled trials of metastatic renal cell carcinoma, including 62 trials with 24,518 patients. The study found a moderate correlation between PFS and OS (r = 0.52) and between ORR and OS (r = -0.59), but insufficient consistency to reliably predict OS benefit.
Key findings
- PFS showed a moderate correlation with OS (r = 0.52; 95% CI, 0.38-0.66).
- ORR demonstrated a moderate correlation with OS (r = -0.59; 95% CI, -0.72, -0.45).
- The surrogate threshold effect for PFS was an HR of 0.92 (95% CI, 0.79-1.09).
- The surrogate threshold effect for ORR was an OR of 1.40 (95% CI, 0.99-1.89).
Why it matters
Understanding the relationship between surrogate endpoints like PFS and ORR with OS is crucial for evaluating treatment efficacy in metastatic renal cell carcinoma. This study highlights the limitations of relying solely on these surrogates for predicting patient outcomes.
What to keep in mind
Substantial heterogeneity among the included trials and limited representation of non-clear cell renal cell carcinoma hindered reliable conclusions.