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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
Statement of
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 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
RMID: 0020102581
DOI: 10.1182/blood-2010-03-277152
Appears in Collections:Medicine publications

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