• Eur. J. Clin. Invest. · Sep 2012

    Review

    Developmental Therapeutics Consortium report on study design effects on trial outcomes in chronic myeloid leukaemia.

    • Francis Giles, François-Xavier Mahon, Bjorn Gjertsen, Ronan Swords, Boris Labar, Anna Turkina, and Gianantonio Rosti.
    • HRB Clinical Research Facility, National University of Ireland Galway and Trinity College Dublin, Dublin, Ireland. frankgiles@aol.com
    • Eur. J. Clin. Invest. 2012 Sep 1; 42 (9): 1016-26.

    BackgroundTyrosine kinase inhibitors (TKIs) have dramatically changed the treatment of chronic myeloid leukaemia (CML). Results from ongoing phase 3 trials with nilotinib [Efficacy and Safety in Clinical Trials-Newly Diagnosed Patients (ENESTnd)] and dasatinib [Dasatinib Versus Imatinib Study in Treatment-Naive CML-CP Patients (DASISION)] in newly diagnosed patients with CML in chronic phase have demonstrated that these TKIs resulted in significant improvements in responses vs. imatinib.DesignThe Developmental Therapeutics Consortium (DTC) systematically reviewed the published literature to provide a comparative analysis of the ENESTnd and DASISION trial designs and data reported on each study.ResultsThe recent approval of nilotinib and dasatinib based on these two pivotal studies offers physicians the option to optimise frontline treatment based on a patient's comorbidities, risk factors and tolerability profiles. Although nilotinib and dasatinib provide effective therapeutic options for the frontline treatment of CML, the lack of an evidenced-based, side-by-side comparison makes it difficult to directly compare these agents.ConclusionsDespite potential bias from differences in patient populations and study design, indirect cross-trial comparisons to determine the relative effectiveness of these agents will be performed by physicians. This DTC report provides a comprehensive summary of the study designs, protocols and results of the ENESTnd and DASISION trials, which will assist physicians in making informed decisions on the best treatment approach for their patients.© 2012 The Authors. European Journal of Clinical Investigation © 2012 Stichting European Society for Clinical Investigation Journal Foundation.

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