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Type: Journal article
Title: Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is active in patients with imatinib-resistant or -intolerant accelerated-phase chronic myelogenous leukemia
Author: le Coutre, P.
Ottmann, O.
Giles, F.
Kim, D.
Cortes, J.
Gattermann, N.
Apperley, J.
Larson, R.
Abruzzese, E.
O'Brien, S.
Kuliczkowski, K.
Hochhaus, A.
Mahon, F.
Saglio, G.
Gobbi, M.
Kwong, Y.
Baccarani, M.
Hughes, T.
Martinelli, G.
Radich, J.
et al.
Citation: Blood, 2008; 111(4):1834-1839
Publisher: American Society of Hematology
Issue Date: 2008
ISSN: 0006-4971
Statement of
Philipp le Coutre, Oliver G. Ottmann, Francis Giles, Dong-Wook Kim, Jorge Cortes, Norbert Gattermann, Jane F. Apperley, Richard A. Larson, Elisabetta Abruzzese, Stephen G. OBrien, Kazimierz Kuliczkowski, Andreas Hochhaus, Francois-Xavier Mahon, Giuseppe Saglio, Marco Gobbi, Yok-Lam Kwong, Michele Baccarani, Timothy Hughes, Giovanni Martinelli, Jerald P. Radich, Ming Zheng, Yaping Shou, and Hagop Kantarjian
Abstract: Patients with imatinib-resistant or -intolerant accelerated-phase chronic myelogenous leukemia (CML-AP) have very limited therapeutic options. Nilotinib is a highly selective BCR-ABL tyrosine kinase inhibitor. This phase 2 trial was designed to characterize the efficacy and safety of nilotinib (400 mg twice daily) in this patient population with hematologic response (HR) as primary efficacy endpoint. A total of 119 patients were enrolled and had a median duration of treatment of 202 days (range, 2–611 days). An HR was observed in 56 patients (47%; 95% confidence interval [CI], 38%-56%). Major cytogenetic response (MCyR) was observed in 35 patients (29%; 95% CI, 21%-39%). The median duration of HR has not been reached. Overall survival rate among the 119 patients after 12 months of follow-up was 79% (95% CI, 70%-87%). Nonhematologic adverse events were mostly mild to moderate. Severe peripheral edema and pleural effusions were not observed. The most common grade 3 or higher hematologic adverse events were thrombocytopenia (35%) and neutropenia (21%). Grade 3 or higher bilirubin and lipase elevations occurred in 9% and 18% of patients, respectively, resulting in treatment discontinuation in one patient. In conclusion, nilotinib is an effective and well-tolerated treatment in imatinib-resistant and -intolerant CML-AP. This trial is registered at as NCT00384228.
Keywords: Humans
Fusion Proteins, bcr-abl
Antineoplastic Agents
Blood Cell Count
Drug Administration Schedule
Dose-Response Relationship, Drug
Drug Resistance
Middle Aged
Protein-Tyrosine Kinases
Leukemia, Myeloid, Accelerated Phase
Imatinib Mesylate
Rights: © 2008 by The American Society of Hematology
DOI: 10.1182/blood-2007-04-083196
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