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

Research output: Contribution to journalArticle

68 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 1 2012
Externally publishedYes

Keywords

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

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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    Le Coutre, P. D., Giles, F. J., Hochhaus, A., Apperley, J. F., Ossenkoppele, G. J., Blakesley, R., Shou, Y., Gallagher, N. J., Baccarani, M., Cortes, J., & Kantarjian, H. M. (2012). Nilotinib in patients with Ph + chronic myeloid leukemia in accelerated phase following imatinib resistance or intolerance: 24-month follow-up results. Leukemia, 26(6), 1189-1194. https://doi.org/10.1038/leu.2011.323