title: Nilotinib is effective in patients with chronic myeloid leukemia in chronic phase after imatinib resistance or intolerance: 24-month follow-up results.
abstract: Nilotinib is a potent selective inhibitor of the BCR-ABL tyrosine kinase approved for use in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP), and in CML-CP and CML-accelerated phase after imatinib failure. Nilotinib (400 mg twice daily) was approved on the basis of the initial results of this phase 2 open-label study. The primary study endpoint was the proportion of patients achieving major cytogenetic response (CyR). All patients were followed for ≥ 24 months or discontinued early. Of 321 patients, 124 (39%) continue on nilotinib treatment. Overall, 59% of patients achieved major CyR; this was complete CyR (CCyR) in 44%. Of patients achieving CCyR, 56% achieved major molecular response. CyRs were durable, with 84% of patients who achieved CCyR maintaining response at 24 months. The overall survival at 24 months was 87%. Adverse events were mostly mild to moderate, generally transient, and easily managed. This study indicates that nilotinib is effective, with a manageable safety profile, and can provide favorable long-term benefits for patients with CML-CP after imatinib failure.
authors.affiliation: The University of Texas M.D. Anderson Cancer Center, Leukemia Department, 1515 Holcombe Blvd, Houston, TX 77030, USA. hkantarj@mdanderson.org
authors.forename: Hagop M
authors.initials: HM
authors.lastname: Kantarjian
authors.forename: Francis J
authors.initials: FJ
authors.lastname: Giles
authors.forename: Kapil N
authors.initials: KN
authors.lastname: Bhalla
authors.forename: Javier
authors.initials: J
authors.lastname: Pinilla-Ibarz
authors.forename: Richard A
authors.initials: RA
authors.lastname: Larson
authors.forename: Norbert
authors.initials: N
authors.lastname: Gattermann
authors.forename: Oliver G
authors.initials: OG
authors.lastname: Ottmann
authors.forename: Andreas
authors.initials: A
authors.lastname: Hochhaus
authors.forename: Jerald P
authors.initials: JP
authors.lastname: Radich
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Saglio
authors.forename: Timothy P
authors.initials: TP
authors.lastname: Hughes
authors.forename: Giovanni
authors.initials: G
authors.lastname: Martinelli
authors.forename: Dong-Wook
authors.initials: DW
authors.lastname: Kim
authors.forename: Yaping
authors.initials: Y
authors.lastname: Shou
authors.forename: Neil J
authors.initials: NJ
authors.lastname: Gallagher
authors.forename: Rick
authors.initials: R
authors.lastname: Blakesley
authors.forename: Michele
authors.initials: M
authors.lastname: Baccarani
authors.forename: Jorge
authors.initials: J
authors.lastname: Cortes
authors.forename: Philipp D
authors.initials: PD
authors.lastname: le Coutre
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D001549:Benzamides; D019008:Drug Resistance, Neoplasm / Q000187:drug effects; D004361:Drug Tolerance / Q000502:physiology; D005500:Follow-Up Studies; D006801:Humans; D000068877:Imatinib Mesylate; D015466:Leukemia, Myeloid, Chronic-Phase / Q000188:drug therapy*; D008875:Middle Aged; D010879:Piperazines / Q000009:adverse effects* / Q000627:therapeutic use*; D011743:Pyrimidines / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D001549:Benzamides; D010879:Piperazines; D011743:Pyrimidines; D000068877:Imatinib Mesylate; C498826:nilotinib