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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
... show 8 more
Identifiers
http://hdl.handle.net/10379/11637
https://doi.org/10.13025/28219
Repository DOI
10.1038/leu.2012.181
Publication Date
2012-07-05
Keywords
nilotinib, imatinib resistance, imatinib intolerance, imatinib failure, tyrosine kinase inhibitors, early molecular response, chronic myelogenous leukemia, to-treat analysis, bcr-abl, selective inhibitor, line therapy, amn107, cml
Type
Article
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Citation
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 (2012). 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
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. Leukemia (2013) 27, 107-112; doi:10.1038/leu.2012.181
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Publisher
Springer Nature
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Attribution-NonCommercial-NoDerivs 3.0 Ireland
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Externally hosted open access publications with University of Galway authors (2)