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https://hdl.handle.net/2440/87759
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dc.contributor.author | le Coutre, P. | - |
dc.contributor.author | Ottmann, O. | - |
dc.contributor.author | Giles, F. | - |
dc.contributor.author | Kim, D. | - |
dc.contributor.author | Cortes, J. | - |
dc.contributor.author | Gattermann, N. | - |
dc.contributor.author | Apperley, J. | - |
dc.contributor.author | Larson, R. | - |
dc.contributor.author | Abruzzese, E. | - |
dc.contributor.author | O'Brien, S. | - |
dc.contributor.author | Kuliczkowski, K. | - |
dc.contributor.author | Hochhaus, A. | - |
dc.contributor.author | Mahon, F. | - |
dc.contributor.author | Saglio, G. | - |
dc.contributor.author | Gobbi, M. | - |
dc.contributor.author | Kwong, Y. | - |
dc.contributor.author | Baccarani, M. | - |
dc.contributor.author | Hughes, T. | - |
dc.contributor.author | Martinelli, G. | - |
dc.contributor.author | Radich, J. | - |
dc.contributor.author | et al. | - |
dc.date.issued | 2008 | - |
dc.identifier.citation | Blood, 2008; 111(4):1834-1839 | - |
dc.identifier.issn | 0006-4971 | - |
dc.identifier.issn | 0006-4971 | - |
dc.identifier.uri | http://hdl.handle.net/2440/87759 | - |
dc.description.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. | - |
dc.description.statementofresponsibility | 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 | - |
dc.language.iso | en | - |
dc.publisher | American Society of Hematology | - |
dc.rights | © 2008 by The American Society of Hematology | - |
dc.source.uri | http://dx.doi.org/10.1182/blood-2007-04-083196 | - |
dc.subject | Humans | - |
dc.subject | Benzamides | - |
dc.subject | Piperazines | - |
dc.subject | Pyrimidines | - |
dc.subject | Fusion Proteins, bcr-abl | - |
dc.subject | Antineoplastic Agents | - |
dc.subject | Blood Cell Count | - |
dc.subject | Drug Administration Schedule | - |
dc.subject | Safety | - |
dc.subject | Dose-Response Relationship, Drug | - |
dc.subject | Drug Resistance | - |
dc.subject | Mutation | - |
dc.subject | Adult | - |
dc.subject | Aged | - |
dc.subject | Middle Aged | - |
dc.subject | Female | - |
dc.subject | Male | - |
dc.subject | Protein-Tyrosine Kinases | - |
dc.subject | Leukemia, Myeloid, Accelerated Phase | - |
dc.subject | Imatinib Mesylate | - |
dc.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 | - |
dc.type | Journal article | - |
dc.identifier.doi | 10.1182/blood-2007-04-083196 | - |
pubs.publication-status | Published | - |
dc.identifier.orcid | Hughes, T. [0000-0002-0910-3730] [0000-0002-7990-4509] | - |
Appears in Collections: | Aurora harvest 2 Medicine publications |
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