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

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142 Scopus citations

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

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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    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. (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