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Surrogate endpoints in advanced sarcoma trials: a meta-analysis.
Marion Savina1,2,3,4, Saskia Litière5, Antoine Italiano6
1Clinical and Epidemiological Research Unit, Institut Bergonié, Comprehensive Cancer Center, Bordeaux cedex 33076, France.
Oncotarget
|October 24, 2018
Summary
Progression-free survival (PFS), time-to-progression (TTP), and time-to-treatment failure (TTF) show weak surrogate properties for overall survival (OS) in advanced soft tissue sarcomas (STS). These endpoints are not reliable predictors of treatment efficacy in STS trials.
Area of Science:
- Oncology
- Clinical Trials
- Biostatistics
Background:
- Alternative endpoints to overall survival (OS) are crucial for assessing treatment efficacy in randomized controlled trials (RCTs).
- The validity of surrogate endpoints like progression-free survival (PFS), time-to-progression (TTP), and time-to-treatment failure (TTF) requires rigorous evaluation.
- Advanced soft tissue sarcomas (STS) present a clinical context where reliable surrogate markers are needed.
Purpose of the Study:
- To evaluate the surrogate properties of PFS, TTP, and TTF for OS in advanced STS.
- To assess the individual- and trial-level associations between these candidate surrogates and OS.
Main Methods:
- A meta-analysis of individual-patient data (IPD) was conducted.
- Phase II/III RCTs involving adult patients with advanced STS were included.
- Statistical methods included weighted linear regression and a two-stage model; association strength was ranked using IQWiG guidelines.
Main Results:
- Fourteen RCTs (N=2846) were analyzed.
- Individual-level associations were moderate, with 12-month PFS showing the highest correlation (Spearman's rho = 0.66).
- Trial-level associations for all three endpoints were ranked as low according to IQWiG criteria.
Conclusions:
- The findings do not support PFS, TTP, or TTF as strong surrogate endpoints for OS in advanced STS.
- These surrogate markers may not be sufficiently reliable for assessing treatment efficacy in this patient population.
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