Dataset Information

Surrogate endpoints in advanced sarcoma trials: a meta-analysis.

ABSTRACT:

Background

Alternative endpoints to overall survival (OS) are frequently used to assess treatment efficacy in randomized controlled trials (RCT). Their properties in terms of surrogate outcomes for OS need to be assessed. We evaluated the surrogate properties of progression-free survival (PFS), time-to-progression (TTP) and time-to-treatment failure (TTF) in advanced soft tissue sarcomas (STS).

Results

A total of 21 trials originally met the selection criteria and 14 RCTs (N = 2846) were included in the analysis. Individual-level associations were moderate (highest for 12-month PFS: Spearman's rho = 0.66; 95% CI [0.63; 0.68]). Trial-level associations were ranked as low for the three endpoints as per the IQWiG criterion.

Materials and methods

We performed a meta-analysis using individual-patient data (IPD). Phase II/III RCTs evaluating therapies for adults with advanced STS were eligible. We estimated the individual- and the trial-level associations between then candidate surrogates and OS. Statistical methods included weighted linear regression and the two-stage model introduced by Buyse and Burzykowski. The strength of the trial-level association was ranked according to the German Institute for Quality and Efficiency in Health Care (IQWiG) guidelines.

Conclusions

Our results do not support strong surrogate properties of PFS, TTP and TTF for OS in advanced STS.

SUBMITTER: Savina M

PROVIDER: S-EPMC6195375 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Publications

Surrogate endpoints in advanced sarcoma trials: a meta-analysis.

Savina Marion M Litière Saskia S Italiano Antoine A Burzykowski Tomasz T Bonnetain Franck F Gourgou Sophie S Rondeau Virginie V Blay Jean-Yves JY Cousin Sophie S Duffaud Florence F Gelderblom Hans H Gronchi Alessandro A Judson Ian I Le Cesne Axel A Lorigan Paul P Maurel Joan J van der Graaf Winette W Verweij Jaap J Mathoulin-Pélissier Simone S Bellera Carine C

Oncotarget 20181002 77

<h4>Background</h4>Alternative endpoints to overall survival (OS) are frequently used to assess treatment efficacy in randomized controlled trials (RCT). Their properties in terms of surrogate outcomes for OS need to be assessed. We evaluated the surrogate properties of progression-free survival (PFS), time-to-progression (TTP) and time-to-treatment failure (TTF) in advanced soft tissue sarcomas (STS).<h4>Results</h4>A total of 21 trials originally met the selection criteria and 14 RCTs (<i>N</i ...[more]

PMID: 30349653

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Dataset Information

Surrogate endpoints in advanced sarcoma trials: a meta-analysis.

Background

Results

Materials and methods

Conclusions

Publications

Surrogate endpoints in advanced sarcoma trials: a meta-analysis.

Similar Datasets

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