Nilotinib is effective in patients with chronic myeloid leukemia in chronic phase after imatinib resistance or intolerance: 24-month follow-up results

Hagop M. Kantarjian, Francis J. Giles, Kapil N. Bhalla, Javier Pinilla-Ibarz, Richard A. Larson, Norbert Gattermann, Oliver G. Ottmann, Andreas Hochhaus, Jerald P. Radich, Giuseppe Saglio, Timothy P. Hughes, Giovanni Martinelli, Dong Wook Kim, Yaping Shou, Neil J. Gallagher, Rick Blakesley, Michele Baccarani, Jorge Cortes, Philipp D. Le Coutre

Research output: Contribution to journalArticlepeer-review

273 Scopus citations

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 completeCyR (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. This trial was registered at www.clinicaltrials.gov as #NCT00109707.

Original languageEnglish (US)
Pages (from-to)1141-1145
Number of pages5
JournalBlood
Volume117
Issue number4
DOIs
StatePublished - Jan 27 2011

ASJC Scopus subject areas

  • Biochemistry
  • Immunology
  • Hematology
  • Cell Biology

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