Clinical profile of dasatinib in Asian and non-Asian patients with chronic myeloid leukemia
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Resistance and intolerance to imatinib are of particular clinical relevance to Asian patients because of their lower body surface area. Dasatinib is 325-fold more potent than imatinib in inhibiting BCR-ABL in vitro and is indicated for the treatment of chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia resistant or intolerant to imatinib. Data from a series of phase I/II research trials were analyzed to compare the efficacy, safety and pharmacokinetic profile of dasatinib 70 mg twice daily in Asian and non-Asian patients. Results from 55 Asian and 615 non-Asian patients demonstrated that the efficacy and safety of dasatinib was comparable. Dasatinib was well tolerated, with no observed toxicities exclusive to Asian patients. A higher incidence of adverse events and lower rate of response observed among Asian patients with myeloid blast phase CML reflected the aggressive nature of the disease. Analyses of noncompartmental pharmacokinetics (5 Asian and 49 non-Asian patients) and population pharmacokinetics (17 Asian and 382 non-Asian patients) were also comparable. The efficacy, safety and pharmacokinetic profile of dasatinib 70 mg twice daily is similar in Asian and non-Asian patients with CML. Dasatinib is therefore an important therapeutic option for this patient population.
KeywordsDasatinib Chronic myeloid leukemia Asian Pharmacokinetics Cytogenetic response
In addition to the authors, the following primary investigators also provided patient data for this analysis: France, Francois-Xavier Mahon; Sweden, Bengt Simonsson; USA, Jorge Cortes, H. Jean Khoury and Michael Mauro. Funding for this research was provided by Bristol-Myers Squibb. Editorial and writing support was provided by Gardiner-Caldwell US, funded by Bristol-Myers Squibb.
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