title: Results of dasatinib therapy in patients with early chronic-phase chronic myeloid leukemia.
abstract: OBJECTIVE
  Dasatinib is effective therapy for chronic myeloid leukemia (CML) after imatinib failure. In this study, we investigate the efficacy of dasatinib as initial therapy for patients with CML in early chronic phase.
  
  
  METHODS
  Patients with newly diagnosed CML in early chronic phase were randomly assigned to receive dasatinib 100 mg once daily or 50 mg twice daily as initial therapy.
  
  
  RESULTS
  Among 50 patients observed for at least 3 months, 49 patients (98%) achieved a complete cytogenetic response (CCyR), and 41 patients (82%) achieved a major molecular response (MMR). Responses occurred rapidly, with 94% of patients achieving CCyR by 6 months. There was no difference in response rate by treatment arm. The projected event-free survival rate at 24 months is 88%, and all patients are alive after a median follow-up time of 24 months. Grade >or= 3 neutropenia and thrombocytopenia occurred in 21% and 10% of patients, respectively. Nonhematologic toxicity was usually grade 1 to 2. There was no significant difference in toxicity between the two arms, and the actual median dose at 12 months was 100 mg (range, 20 to 100 mg).
  
  
  CONCLUSIONS
  Dasatinib is an effective agent for the initial management of CML in early chronic phase, producing high rates of CCyR and MMR.
authors.affiliation: Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA. jcortes@mdanderson.org
authors.forename: Jorge E
authors.initials: JE
authors.lastname: Cortes
authors.forename: Dan
authors.initials: D
authors.lastname: Jones
authors.forename: Susan
authors.initials: S
authors.lastname: O'Brien
authors.forename: Elias
authors.initials: E
authors.lastname: Jabbour
authors.forename: Farhad
authors.initials: F
authors.lastname: Ravandi
authors.forename: Charles
authors.initials: C
authors.lastname: Koller
authors.forename: Gautam
authors.initials: G
authors.lastname: Borthakur
authors.forename: Brenda
authors.initials: B
authors.lastname: Walker
authors.forename: Weiqiang
authors.initials: W
authors.lastname: Zhao
authors.forename: Jianqin
authors.initials: J
authors.lastname: Shan
authors.forename: Hagop
authors.initials: H
authors.lastname: Kantarjian
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000069439:Dasatinib; D006801:Humans; D015466:Leukemia, Myeloid, Chronic-Phase / Q000188:drug therapy*; D008875:Middle Aged; D011743:Pyrimidines / Q000627:therapeutic use*; D013844:Thiazoles / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D011743:Pyrimidines; D013844:Thiazoles; D000069439:Dasatinib