Please use this identifier to cite or link to this item: http://hdl.handle.net/2440/89719
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Type: Journal article
Title: Early molecular response predicts outcomes in patients with chronic myeloid leukemia in chronic phase treated with frontline nilotinib or imatinib
Author: Hughes, T.
Saglio, G.
Kantarjian, H.
Guilhot, F.
Niederwieser, D.
Rosti, G.
Nakaseko, C.
De Souza, C.
Kalaycio, M.
Meier, S.
Fan, X.
Menssen, H.
Larson, R.
Hochhaus, A.
Citation: Blood, 2014; 123(9):1353-1360
Publisher: American Society of Hematology
Issue Date: 2014
ISSN: 0006-4971
1528-0020
Statement of
Responsibility: 
Timothy P. Hughes, Giuseppe Saglio, Hagop M. Kantarjian, François Guilhot, Dietger Niederwieser, Gianantonio Rosti, Chiaki Nakaseko, Carmino Antonio De Souza, Matt E. Kalaycio, Stephan Meier, Xiaolin Fan, Hans D. Menssen, Richard A. Larson, and Andreas Hochhaus
Abstract: We explored the impact of early molecular response (EMR; BCR-ABL ≤10% on the international scale [BCR-ABL(IS)] at 3 or 6 months) on outcomes in patients with newly diagnosed chronic myeloid leukemia in chronic phase treated with nilotinib or imatinib based on 4 years of follow up in Evaluating Nilotinib Efficacy and Safety in Clinical Trials-Newly Diagnosed Patients. Patients (n = 846) received nilotinib 300 mg twice daily, nilotinib 400 mg twice daily, or imatinib 400 mg once daily. At 3 months, more patients had EMR failure (ie, BCR-ABL(IS) >10%) on imatinib (33%) than on nilotinib (9%-11%); similarly at 6 months, 16% of patients in the imatinib arm vs 3% and 7% in the nilotinib arms had EMR failure. In all arms, EMR failure was associated with lower rates of molecular response, an increased risk of progression, and lower overall survival compared with EMR achievement. We also analyzed patient and treatment characteristics associated with EMR and found distinct patterns in the nilotinib arms vs the imatinib arm. High Sokal risk score was associated with a high rate of EMR failure on imatinib, but not on nilotinib. In contrast, reduced dose intensity and dose interruptions were strongly associated with EMR failure in nilotinib-treated, but not imatinib-treated, patients. This study is registered at www.clinicaltrials.gov as #NCT00471497.
Keywords: Benzamides; Piperazines; Pyrimidines; Antineoplastic Agents; Fusion Proteins, bcr-abl; Protein Kinase Inhibitors; Gene Expression Regulation, Neoplastic; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Rights: © 2014 by The American Society of Hematology
RMID: 0030021305
DOI: 10.1182/blood-2013-06-510396
Appears in Collections:Medicine publications

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