title: Nilotinib as front-line treatment for patients with chronic myeloid leukemia in early chronic phase.
abstract: OBJECTIVE
  Although most patients with chronic myeloid leukemia (CML) in chronic phase respond well to front-line therapy with imatinib, some patients do not achieve the desirable end point, and others may eventually lose response or are intolerant.
  
  
  METHODS
  Patients with newly diagnosed CML in chronic phase were treated with nilotinib 400 mg twice daily on an empty stomach as initial therapy.
  
  
  RESULTS
  Among 51 patients in chronic phase observed for at least 3 months, 50 (98%) achieved a complete cytogenetic remission (CCyR), and 39 (76%) achieved a major molecular response (MMR). Responses occurred rapidly, with 96% of patients achieving CCyR by 3 months and 98% achieving CCyR by 6 months. The projected event-free survival at 24 months is 90%, and all patients are alive after a median follow-up time of 17 months. Grade >or= 3 neutropenia occurred in 12% of patients, and thrombocytopenia in occurred 11%. Nonhematologic toxicity was usually grade 1 to 2 and manageable. The actual median dose at 12 months was 800 mg (range, 200 to 800 mg).
  
  
  CONCLUSIONS
  Nilotinib is an effective option for the initial management of CML in early chronic phase, producing high rates of CCyR and MMR, with most patients reaching these responses early during their therapy.
authors.affiliation: Departments of Leukemia and Hematopathology, 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: Marina
authors.initials: M
authors.lastname: Konopleva
authors.forename: Alessandra
authors.initials: A
authors.lastname: Ferrajoli
authors.forename: Tapan
authors.initials: T
authors.lastname: Kadia
authors.forename: Gautam
authors.initials: G
authors.lastname: Borthakur
authors.forename: Denise
authors.initials: D
authors.lastname: Stigliano
authors.forename: Jianqin
authors.initials: J
authors.lastname: Shan
authors.forename: Hagop
authors.initials: H
authors.lastname: Kantarjian
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015466:Leukemia, Myeloid, Chronic-Phase / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011743:Pyrimidines / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D011743:Pyrimidines; C498826:nilotinib