• Statistics in medicine · Jul 2010

    Joint modeling of progression-free survival and death in advanced cancer clinical trials.

    • David Dejardin, Emmanuel Lesaffre, and Geert Verbeke.
    • Interuniversity Institute for Biostatistics and Statistical Bioinformatics, Katholieke Universiteit Leuven and Universiteit Hasselt, Kapucijnenvoer 35, Block D, bus 7001, B3000 Leuven, Belgium. david.dejardin@med.kuleuven.be
    • Stat Med. 2010 Jul 20; 29 (16): 1724-34.

    AbstractProgression-related endpoints (such as time to progression or progression-free survival) and time to death are common endpoints in cancer clinical trials. It is of interest to study the link between progression-related endpoints and time to death (e.g. to evaluate the degree of surrogacy). However, current methods ignore some aspects of the definitions of progression-related endpoints. We review those definitions and investigate their impact on modeling the joint distribution. Further, we propose a multi-state model in which the association between the endpoints is modeled through a frailty term. We also argue that interval-censoring needs to be taken into account to more closely match the latent disease evolution. The joint distribution and an expression for Kendall's tau are derived. The model is applied to data from a clinical trial in advanced metastatic ovarian cancer.Copyright (c) 2010 John Wiley & Sons, Ltd.

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