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https://hdl.handle.net/2440/70321
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Type: | Journal article |
Title: | Nilotinib is effective in patients with chronic myeloid leukemia in chronic phase after imatinib resistance or intolerance: 24-month follow-up results |
Author: | Kantarjian, H. Giles, F. Bhalla, K. Pinilla-Ibarz, J. Larson, R. Gattermann, N. Ottmann, O. Hochhaus, A. Radich, J. Saglio, G. Hughes, T. Martinelli, G. Kim, D. Shou, Y. Gallagher, N. Blakesley, R. Baccarani, M. Cortes, J. le Coutre, P. |
Citation: | Blood, 2011; 117(4):1141-1145 |
Publisher: | Amer Soc Hematology |
Issue Date: | 2011 |
ISSN: | 0006-4971 1528-0020 |
Statement of Responsibility: | Hagop M. Kantarjian, Francis J. Giles, Kapil N. Bhalla, Javier Pinilla-Ibarz,Richard A. Larson, Norbert Gattermann, Oliver G. Ottmann, Andreas Hochhaus, Giuseppe Saglio, Timothy P. Hughes, Giovanni Martinelli, Dong-Wook Kim, Yaping Shou, Neil J. Gallagher, Rick Blakesley, Michele Baccarani, Jorge Cortes and Philipp D. le Coutre |
Abstract: | Nilotinib is a potent selective inhibitor of the BCR-ABL tyrosine kinase approved for use in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CMLCP), and in CML-CP and CML-accelerated phase after imatinib failure. Nilotinib (400 mg twice daily) was approved on the basis of the initial results of this phase 2 open-label study. The primary study endpoint was the proportion of patients achieving major cytogenetic response (CyR). All patients were followed for > 24 months or discontinued early. Of 321 patients, 124 (39%) continue on nilotinib treatment. Overall, 59% of patients achieved major CyR; this was completeCyR(CCyR) in 44%. Of patients achieving CCyR,56% achieved major molecular response. CyRs were durable, with 84% of patients who achieved CCyR maintaining response at 24 months. The overall survival at 24 months was 87%. Adverse events were mostly mild to moderate, generally transient, and easily managed. This study indicates that nilotinib is effective, with a manageable safety profile, and can provide favorable long-term benefits for patients with CML-CP after imatinib failure. This trial was registered at www.clinicaltrials.gov as #NCT00109707. |
Keywords: | Humans Leukemia, Myeloid, Chronic-Phase Benzamides Piperazines Pyrimidines Antineoplastic Agents Treatment Outcome Follow-Up Studies Drug Resistance, Neoplasm Drug Tolerance Time Factors Adult Aged Aged, 80 and over Middle Aged Young Adult Imatinib Mesylate |
Rights: | © 2011 by The American Society of Hematology |
DOI: | 10.1182/blood-2010-03-277152 |
Published version: | http://dx.doi.org/10.1182/blood-2010-03-277152 |
Appears in Collections: | Aurora harvest Medicine publications |
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