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Title: Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic phase: 5-year update of the randomized ENESTnd trial
Authors: A. Hochhaus
G. Saglio
T. P. Hughes
R. A. Larson
D. W. Kim
S. Issaragrisil
P. D. Le Coutre
G. Etienne
P. E. Dorlhiac-Llacer
R. E. Clark
I. W. Flinn
H. Nakamae
B. Donohue
W. Deng
D. Dalal
H. D. Menssen
H. M. Kantarjian
Universitatsklinikum Jena und Medizinische Fakultat
Università degli Studi di Torino
The University of Adelaide
University of Chicago
The Catholic University of Korea
Mahidol University
Charité – Universitätsmedizin Berlin
Institut Bergonie
Universidade de Sao Paulo - USP
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Sarah Cannon Research Institute
Osaka City University
Novartis Pharmaceuticals Corporation
Novartis International AG
University of Texas MD Anderson Cancer Center
Keywords: Biochemistry, Genetics and Molecular Biology
Issue Date: 1-May-2016
Citation: Leukemia. Vol.30, No.5 (2016), 1044-1054
Abstract: © 2016 Macmillan Publishers Limited. In the phase 3 Evaluating Nilotinib Efficacy and Safety in Clinical Trials-Newly Diagnosed Patients (ENESTnd) study, nilotinib resulted in earlier and higher response rates and a lower risk of progression to accelerated phase/blast crisis (AP/BC) than imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP). Here, patients' long-term outcomes in ENESTnd are evaluated after a minimum follow-up of 5 years. By 5 years, more than half of all patients in each nilotinib arm (300 mg twice daily, 54%; 400 mg twice daily, 52%) achieved a molecular response 4.5 (MR 4.5; BCR-ABL≤0.0032% on the International Scale) compared with 31% of patients in the imatinib arm. A benefit of nilotinib was observed across all Sokal risk groups. Overall, safety results remained consistent with those from previous reports. Numerically more cardiovascular events (CVEs) occurred in patients receiving nilotinib vs imatinib, and elevations in blood cholesterol and glucose levels were also more frequent with nilotinib. In contrast to the high mortality rate associated with CML progression, few deaths in any arm were associated with CVEs, infections or pulmonary diseases. These long-term results support the positive benefit-risk profile of frontline nilotinib 300 mg twice daily in patients with CML-CP.
ISSN: 14765551
Appears in Collections:Scopus 2016-2017

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