title: Clinical profile of dasatinib in Asian and non-Asian patients with chronic myeloid leukemia.
abstract: 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.
authors.affiliation: Division of Hematology, Seoul St Mary's Hospital, The Catholic University of Korea, Seocho-gu, Seoul, Korea. dwkim@catholic.ac.kr
authors.forename: Dong-Wook
authors.initials: DW
authors.lastname: Kim
authors.forename: Yeow-Tee
authors.initials: YT
authors.lastname: Goh
authors.forename: Hui-Hua
authors.initials: HH
authors.lastname: Hsiao
authors.forename: Priscilla B
authors.initials: PB
authors.lastname: Caguioa
authors.forename: Dongho
authors.initials: D
authors.lastname: Kim
authors.forename: Wan-Seok
authors.initials: WS
authors.lastname: Kim
authors.forename: Tapan
authors.initials: T
authors.lastname: Saikia
authors.forename: Shruti
authors.initials: S
authors.lastname: Agrawal
authors.forename: Amit
authors.initials: A
authors.lastname: Roy
authors.forename: David
authors.initials: D
authors.lastname: Dai
authors.forename: M Brigid
authors.initials: MB
authors.lastname: Bradley-Garelik
authors.forename: Jaydip
authors.initials: J
authors.lastname: Mukhopadhyay
authors.forename: Saengsuree
authors.initials: S
authors.lastname: Jootar
mesh_terms: D044466:Asian People; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D000069439:Dasatinib; D003627:Data Interpretation, Statistical; D004341:Drug Evaluation / Q000706:statistics & numerical data*; D006801:Humans; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000188:drug therapy*; D011743:Pyrimidines / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D013844:Thiazoles / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D011743:Pyrimidines; D013844:Thiazoles; D000069439:Dasatinib