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.
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le Coutre, Philipp, Ottmann, Oliver G, Giles, Francis, Kim, Dong-Wook, Cortes, Jorge, Gattermann, Norbert, Apperley, Jane F, Larson, Richard A, Abruzzese, Elisabetta, O'Brien, Stephen G, Kuliczkowski, Kazimierz, Hochhaus, Andreas, Mahon, Francois-Xavier, Saglio, Giuseppe, Gobbi, Marco, Kwong, Yok-Lam, Baccarani, Michele, Hughes, Timothy, Martinelli, Giovanni, Radich, Jerald P, Zheng, Ming, 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.
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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 |