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, Gianantonio Rosti

Research output: Contribution to journalReview articlepeer-review

1 Scopus citations

Abstract

Background Tyrosine 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. Design The 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. Results The 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. Conclusions Despite 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.

Original languageEnglish (US)
Pages (from-to)1016-1026
Number of pages11
JournalEuropean journal of clinical investigation
Volume42
Issue number9
DOIs
StatePublished - Sep 2012

Keywords

  • Chronic myeloid leukaemia
  • Dasatinib
  • Developmental Therapeutics Consortium
  • Imatinib
  • Nilotinib
  • Tyrosine kinase inhibitors

ASJC Scopus subject areas

  • Medicine(all)
  • Clinical Biochemistry
  • Biochemistry

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