{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,5,18]],"date-time":"2024-05-18T00:54:11Z","timestamp":1715993651608},"reference-count":53,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2012,5,1]],"date-time":"2012-05-01T00:00:00Z","timestamp":1335830400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Eur J Clin Investigation"],"published-print":{"date-parts":[[2012,9]]},"abstract":"<jats:sec><jats:label \/><jats:p>Eur J Clin Invest 2012; 42 (9): 1016\u20131026<\/jats:p><\/jats:sec><jats:sec><jats:title>Abstract<\/jats:title><jats:p><jats:bold>Background\u2002<\/jats:bold> 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\u2014Newly Diagnosed Patients (ENESTnd)] and dasatinib [Dasatinib Versus Imatinib Study in Treatment\u2010Naive CML\u2010CP Patients (DASISION)] in newly diagnosed patients with CML in chronic phase have demonstrated that these TKIs resulted in significant improvements in responses vs. imatinib.<\/jats:p><jats:p><jats:bold>Design\u2002<\/jats:bold> 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.<\/jats:p><jats:p><jats:bold>Results\u2002<\/jats:bold> 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\u2019s 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\u2010based, side\u2010by\u2010side comparison makes it difficult to directly compare these agents.<\/jats:p><jats:p><jats:bold>Conclusions\u2002<\/jats:bold> Despite potential bias from differences in patient populations and study design, indirect cross\u2010trial 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.<\/jats:p><\/jats:sec>","DOI":"10.1111\/j.1365-2362.2012.02675.x","type":"journal-article","created":{"date-parts":[[2012,3,31]],"date-time":"2012-03-31T04:26:25Z","timestamp":1333167985000},"page":"1016-1026","source":"Crossref","is-referenced-by-count":1,"title":["Developmental Therapeutics Consortium report on study design effects on trial outcomes in chronic myeloid 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