Nilotinib in imatinib-resistant or imatinib-intolerant patients with chronic myeloid leukemia in chronic phase: 48-month follow-up results of a phase II study

F. J. Giles, P. D. Le Coutre, J. Pinilla-Ibarz, R. A. Larson, N. Gattermann, O. G. Ottmann, A. Hochhaus, J. P. Radich, G. Saglio, T. P. Hughes, G. Martinelli, D. W. Kim, S. Novick, K. Gillis, X. Fan, J. Cortes, M. Baccarani, H. M. Kantarjian

Research output: Contribution to journalArticle

Abstract

Nilotinib (Tasigna) is a BCR-ABL1 tyrosine kinase inhibitor approved for the treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (CML-CP) who are newly diagnosed or intolerant of or resistant to imatinib. The 48-month follow-up data for patients with CML-CP treated with nilotinib after imatinib resistance or intolerance on an international phase II study were analyzed. Overall, 59% of patients achieved major cytogenetic response; 45% achieved complete cytogenetic response while on study. The estimated rate of overall survival (OS) and progression-free survival (PFS) at 48 months was 78% and 57%, respectively. Deeper levels of molecular responses at 3 and 6 months were highly positively correlated with long-term outcomes, including PFS and OS at 48 months. Of the 321 patients initially enrolled in the study, 98 (31%) were treated for at least 48 months. Discontinuations were primarily due to disease progression (30%) or adverse events (21%). Nilotinib is safe and effective for long-term use in responding patients with CML-CP who are intolerant of or resistant to imatinib. Further significant improvements in therapy are required for patients who are resistant or intolerant to imatinib.

Original languageEnglish (US)
Pages (from-to)107-112
Number of pages6
JournalLeukemia
Volume27
Issue number1
DOIs
StatePublished - Jan 1 2013
Externally publishedYes

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Leukemia, Myeloid, Chronic Phase
Cytogenetics
Disease-Free Survival
Philadelphia Chromosome
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Protein-Tyrosine Kinases
Disease Progression
4-methyl-N-(3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-pyridin-3-ylpyrimidin-2-yl)amino)benzamide
Imatinib Mesylate
Survival Rate
Survival
Therapeutics

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

Cite this

Giles, F. J., Le Coutre, P. D., Pinilla-Ibarz, J., Larson, R. A., Gattermann, N., Ottmann, O. G., ... Kantarjian, H. M. (2013). Nilotinib in imatinib-resistant or imatinib-intolerant patients with chronic myeloid leukemia in chronic phase: 48-month follow-up results of a phase II study. Leukemia, 27(1), 107-112. https://doi.org/10.1038/leu.2012.181

Nilotinib in imatinib-resistant or imatinib-intolerant patients with chronic myeloid leukemia in chronic phase : 48-month follow-up results of a phase II study. / Giles, F. J.; Le Coutre, P. D.; Pinilla-Ibarz, J.; Larson, R. A.; Gattermann, N.; Ottmann, O. G.; Hochhaus, A.; Radich, J. P.; Saglio, G.; Hughes, T. P.; Martinelli, G.; Kim, D. W.; Novick, S.; Gillis, K.; Fan, X.; Cortes, J.; Baccarani, M.; Kantarjian, H. M.

In: Leukemia, Vol. 27, No. 1, 01.01.2013, p. 107-112.

Research output: Contribution to journalArticle

Giles, FJ, Le Coutre, PD, Pinilla-Ibarz, J, Larson, RA, Gattermann, N, Ottmann, OG, Hochhaus, A, Radich, JP, Saglio, G, Hughes, TP, Martinelli, G, Kim, DW, Novick, S, Gillis, K, Fan, X, Cortes, J, Baccarani, M & Kantarjian, HM 2013, 'Nilotinib in imatinib-resistant or imatinib-intolerant patients with chronic myeloid leukemia in chronic phase: 48-month follow-up results of a phase II study', Leukemia, vol. 27, no. 1, pp. 107-112. https://doi.org/10.1038/leu.2012.181
Giles, F. J. ; Le Coutre, P. D. ; Pinilla-Ibarz, J. ; Larson, R. A. ; Gattermann, N. ; Ottmann, O. G. ; Hochhaus, A. ; Radich, J. P. ; Saglio, G. ; Hughes, T. P. ; Martinelli, G. ; Kim, D. W. ; Novick, S. ; Gillis, K. ; Fan, X. ; Cortes, J. ; Baccarani, M. ; Kantarjian, H. M. / Nilotinib in imatinib-resistant or imatinib-intolerant patients with chronic myeloid leukemia in chronic phase : 48-month follow-up results of a phase II study. In: Leukemia. 2013 ; Vol. 27, No. 1. pp. 107-112.
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