Nilotinib in patients with Ph + chronic myeloid leukemia in accelerated phase following imatinib resistance or intolerance: 24-month follow-up results

P. D. Le Coutre*, F. J. Giles, A. Hochhaus, J. F. Apperley, G. J. Ossenkoppele, R. Blakesley, Y. Shou, N. J. Gallagher, M. Baccarani, J. Cortes, H. M. Kantarjian

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

70 Scopus citations

Abstract

Nilotinib (Tasigna) is a potent and selective BCR-ABL inhibitor approved for use in patients with newly diagnosed chronic myeloid leukemia (CML) in chronic phase (CML-CP) and in patients with CML-CP and accelerated phase (CML-AP) who are resistant to or intolerant of imatinib. Patients with CML-AP (N=137) with at least 24 months of follow-up or who discontinued early were evaluated to determine the efficacy and tolerability of nilotinib. The majority (55%) of patients achieved a confirmed hematologic response, and 31% attained a confirmed complete hematologic response on nilotinib treatment. Overall, 32% of patients achieved major cytogenetic responses (MCyR), with most being complete cytogenetic responses. Responses were durable, with 66% of patients maintaining MCyR at 24 months. The estimated overall and progression-free survival rates at 24 months were 70% and 33%, respectively. Grade 3/4 neutropenia and thrombocytopenia were each observed in 42% of patients. Non-hematologic adverse events were mostly mild to moderate; the safety profile of nilotinib has not changed with longer follow-up. In all, 20 (15%) patients remained on study at data cutoff. In summary, nilotinib has a manageable safety profile, and can provide favorable long-term outcomes in the pretreated CML-AP patient population for whom treatment options are limited.

Original languageEnglish (US)
Pages (from-to)1189-1194
Number of pages6
JournalLeukemia
Volume26
Issue number6
DOIs
StatePublished - Jun 2012

Keywords

  • BCR-ABL
  • Nilotinib
  • chronic myeloid leukemia (CML)
  • imatinib

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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