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    Surrogate endpoints in advanced sarcoma trials: a meta-analysis

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    Authors
    Savina, M
    Litiere, S
    Italiano, A
    Burzykowski, T
    Bonnetain, F
    Gourgou, S
    Rondeau, V
    Blay, JY
    Cousin, S
    Duffaud, F
    Gelderblom, H
    Gronchi, A
    Judson, I
    Le, CA
    Lorigan, Paul C
    Maurel, J
    van der Graaf, W
    Verweij, J
    Mathoulin-Pelissier, S
    Bellera, C
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    Affiliation
    Clinical and Epidemiological Research Unit, Institut Bergonie, Comprehensive Cancer Center, Bordeaux cedex 33076, France
    Issue Date
    2018
    
    Metadata
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    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.
    Citation
    Savina M, Liti�re S, Italiano A, Burzykowski T, Bonnetain F, Gourgou S, et al. Surrogate endpoints in advanced sarcoma trials: a meta-analysis. Oncotarget. 2018 Sep 18;9(77).
    Journal
    Oncotarget
    URI
    http://hdl.handle.net/10541/621353
    DOI
    10.18632/oncotarget.26166
    PubMed ID
    30349653
    Additional Links
    https://dx.doi.org/10.18632/oncotarget.26166
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.18632/oncotarget.26166
    Scopus Count
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