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dc.contributor.authorle Coutre, P D
dc.contributor.authorGiles, F J
dc.contributor.authorHochhaus, A
dc.contributor.authorApperley, J F
dc.contributor.authorOssenkoppele, G J
dc.contributor.authorBlakesley, R
dc.contributor.authorShou, Y
dc.contributor.authorGallagher, N J
dc.contributor.authorBaccarani, M
dc.contributor.authorCortes, J
dc.contributor.authorKantarjian, H M
dc.identifier.citationle 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 (2011). 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
dc.description.abstractNilotinib (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.
dc.publisherSpringer Nature
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 Ireland
dc.subjectchronic myeloid leukemia (cml)
dc.subjectchronic myelogenous leukemia
dc.subjectharmonizing current methodology
dc.subjecttyrosine kinase inhibitors
dc.subjectbcr-abl transcripts
dc.subjectin-vitro activity
dc.subjectcytogenetic responses
dc.subjectselective inhibitor
dc.subjectdomain mutations
dc.subjectformerly amn107
dc.subjectworking party
dc.titleNilotinib in patients with ph+ chronic myeloid leukemia in accelerated phase following imatinib resistance or intolerance: 24-month follow-up results

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