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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.

le Coutre, Philipp and Ottmann, Oliver G and Giles, Francis and Kim, Dong-Wook and Cortes, Jorge and Gattermann, Norbert and Apperley, Jane F and Larson, Richard A and Abruzzese, Elisabetta and O'Brien, Stephen G and Kuliczkowski, Kazimierz and Hochhaus, Andreas and Mahon, Francois-Xavier and Saglio, Giuseppe and Gobbi, Marco and Kwong, Yok-Lam and Baccarani, Michele and Hughes, Timothy and Martinelli, Giovanni and Radich, Jerald P and Zheng, Ming and Shou, Yaping and Kantarjian, Hagop (2008) 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. Blood, 111 (4). pp. 1834-1839. ISSN 0006-4971

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.

Item Type: Article
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Date Deposited: 14 Dec 2009 14:04
Last Modified: 14 Dec 2009 14:04
URI: https://oak.novartis.com/id/eprint/195

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