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https://hdl.handle.net/2440/87759
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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 0006-4971 |
Statement of Responsibility: | 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 www.clinicaltrials.gov as NCT00384228. |
Keywords: | Humans Benzamides Piperazines Pyrimidines Fusion Proteins, bcr-abl Antineoplastic Agents Blood Cell Count Drug Administration Schedule Safety Dose-Response Relationship, Drug Drug Resistance Mutation Adult Aged Middle Aged Female Male Protein-Tyrosine Kinases Leukemia, Myeloid, Accelerated Phase Imatinib Mesylate |
Rights: | © 2008 by The American Society of Hematology |
DOI: | 10.1182/blood-2007-04-083196 |
Published version: | http://dx.doi.org/10.1182/blood-2007-04-083196 |
Appears in Collections: | Aurora harvest 2 Medicine publications |
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