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| |  Patients With Chronic Myeloid Leukaemia Achieve Strong Response With Early Dasatinib Treatment: Presented at ASH By Ed Susman NEW ORLEANS -- December 9, 2009 -- Patients with chronic myeloid leukaemia treated with once-daily dasatinib achieved a high level of complete responses, researchers stated here at the American Society of Hematology (ASH) 51st Annual Meeting and Exposition. In an oral presentation on December 8, Jorge Cortes, MD, University of Texas, M. D. Anderson Cancer Center, Houston, Texas, said, “Dasatinib induced rapid complete cytogenetic responses in most patients. We found similar efficacy and better tolerance with the once-daily regimen.” The difference in the regimens was apparent early in the trial, and a twice-daily regimen was dropped from the study in favour of the once-a-day dose of dasatinib 100 mg. In the twice-daily schedule patients received dasatinib 50 mg. Dr. Cortes said the trial will accrue 100 patients, but his report dealt with 72 patients enrolled in the study. Those patients had a median age of 49 years, and had a low or intermediate Sokal risk score. The follow-up was about 25 months. Patients were eligible for the study if they were diagnosed as positive for the Philadelphia chromosome chronic myeloid leukaemia and had no prior therapy or had less than 1 month therapy of interferon or imatinib. Of the 65 evaluable patients, 62 achieved a complete haematologic response, and 67 of 70 patients who have been treated, and for whom complete testing was available, had achieved a complete cytogenetic response (96% of the patients). Dr. Cortes said 55 of the 70 patients achieved a major molecular response (79%) and 8 of the 70 patients had achieved a complete molecular response (11%). Through 40-plus months on the study, there have been no fatalities. Grade 3/4 adverse events that appeared more frequently in the twice-daily treatment included shortness of breath and neuropathy. Among patients taking once-daily treatment 10% experienced grade 3/4 fatigue and 13% experienced grade 3/4 muscle or joint pain. Dr. Cortes said the results compare favourably with historical data achieved by imatinib in similar populations. Funding for this study was provided by the University of Texas M. D. Anderson Cancer Center, Bristol-Myers Squibb, Novartis, Wyeth, MGI Pharma (Eisai), and Genzyme. [Presentation title: Efficacy of Dasatinib in Patients (pts) With Previously Untreated Chronic Myelogenous Leukemia (CML) in Early Chronic Phase (CML-CP). Abstract 338]
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