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|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.|
|Citation:||Blood, 2008; 111(4):1834-1839|
|Publisher:||American Society of Hematology|
|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|
|Appears in Collections:||Medicine publications|
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