Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic phase: 5-year update of the ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2016-02-03

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

ABSTRACT

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 (MR4.5; 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. More... »

PAGES

1044-1054

Journal

TITLE

Leukemia

ISSUE

5

VOLUME

30

Identifiers

URI

http://scigraph.springernature.com/pub.10.1038/leu.2016.5

DOI

http://dx.doi.org/10.1038/leu.2016.5

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1041273297

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/26837842


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24 schema:description 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 (MR4.5; 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.
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31 CML-CP
32 ENESTnd
33 ENESTnd trial
34 Nilotinib Efficacy
35 Sokal risk group
36 accelerated phase/blast crisis
37 arm
38 benefit-risk profile
39 benefits
40 blast crisis
41 blood cholesterol
42 cardiovascular events
43 cholesterol
44 chronic myeloid leukemia
45 chronic phase
46 clinical trials
47 contrast
48 crisis
49 death
50 disease
51 efficacy
52 elevation
53 events
54 glucose levels
55 group
56 half
57 high mortality rate
58 high response rate
59 imatinib
60 imatinib arm
61 infection
62 leukemia
63 levels
64 long-term benefits
65 long-term outcomes
66 long-term results
67 lower risk
68 molecular response 4.5
69 more cardiovascular events
70 mortality rate
71 myeloid leukemia
72 nilotinib
73 nilotinib 300
74 nilotinib arm
75 outcomes
76 patient studies
77 patients
78 patients' long-term outcomes
79 phase
80 phase 3
81 positive benefit-risk profile
82 previous reports
83 profile
84 progression
85 pulmonary disease
86 rate
87 report
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89 results
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92 safety
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94 study
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