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
Larson, R A
Ottmann, O G
Radich, J P
Hughes, T P
Kantarjian, H M
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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 (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
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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Giles, F J; O'Dwyer, M; Swords, R (Springer Nature, 2009-05-28)Tyrosine kinase inhibitors have revolutionized the treatment of chronic myeloid leukemia (CML), offering patients several targeted therapeutic options that provide the possibility of sustained remissions and prolonged ...
Prediction of outcomes in patients with ph+ chronic myeloid leukemia in chronic phase treated with nilotinib after imatinib resistance/intolerance Jabbour, E; le Coutre, P D; Cortes, J; Giles, F; Bhalla, K N; Pinilla-Ibarz, J; Larson, R A; Gattermann, N; Ottmann, O G; Hochhaus, A; Hughes, T P; Saglio, G; Radich, J P; Kim, D-W; Martinelli, G; Reynolds, J; Woodman, R C; Baccarani, M; Kantarjian, H M (Springer Nature, 2012-11-06)The purpose was to assess predictive factors for outcome in patients with chronic myeloid leukemia (CML) in chronic phase (CML-CP) treated with nilotinib after imatinib failure. Imatinib-resistant and -intolerant patients ...
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