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.
Identifieur interne : 001E87 ( PubMed/Corpus ); précédent : 001E86; suivant : 001E88Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic phase: 5-year update of the randomized ENESTnd trial.
Auteurs : 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 KantarjianSource :
- Leukemia [ 1476-5551 ] ; 2016.
English descriptors
- KwdEn :
- Blood Glucose (metabolism), Cholesterol (blood), Follow-Up Studies, Humans, Imatinib Mesylate (administration & dosage), Imatinib Mesylate (pharmacology), Leukemia, Myelogenous, Chronic, BCR-ABL Positive (blood), Leukemia, Myelogenous, Chronic, BCR-ABL Positive (drug therapy), Leukemia, Myelogenous, Chronic, BCR-ABL Positive (mortality), Leukemia, Myeloid, Chronic-Phase (blood), Leukemia, Myeloid, Chronic-Phase (drug therapy), Leukemia, Myeloid, Chronic-Phase (mortality), Pyrimidines (administration & dosage), Pyrimidines (pharmacology), Risk Assessment, Treatment Outcome.
- MESH :
- chemical , administration & dosage : Imatinib Mesylate, Pyrimidines.
- chemical , blood : Cholesterol.
- chemical , metabolism : Blood Glucose.
- chemical , pharmacology : Imatinib Mesylate, Pyrimidines.
- blood : Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase.
- drug therapy : Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase.
- mortality : Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase.
- Follow-Up Studies, Humans, Risk Assessment, Treatment Outcome.
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 (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.
DOI: 10.1038/leu.2016.5
PubMed: 26837842
Links to Exploration step
pubmed:26837842Le document en format XML
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<author><name sortKey="Hughes, T P" sort="Hughes, T P" uniqKey="Hughes T" first="T P" last="Hughes">T P Hughes</name>
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</affiliation>
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<author><name sortKey="Issaragrisil, S" sort="Issaragrisil, S" uniqKey="Issaragrisil S" first="S" last="Issaragrisil">S. Issaragrisil</name>
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</affiliation>
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<author><name sortKey="Flinn, I W" sort="Flinn, I W" uniqKey="Flinn I" first="I W" last="Flinn">I W Flinn</name>
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</affiliation>
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<author><name sortKey="Nakamae, H" sort="Nakamae, H" uniqKey="Nakamae H" first="H" last="Nakamae">H. Nakamae</name>
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</affiliation>
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<author><name sortKey="Donohue, B" sort="Donohue, B" uniqKey="Donohue B" first="B" last="Donohue">B. Donohue</name>
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</affiliation>
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<author><name sortKey="Deng, W" sort="Deng, W" uniqKey="Deng W" first="W" last="Deng">W. Deng</name>
<affiliation><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation>
</affiliation>
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<front><div type="abstract" xml:lang="en">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.</div>
</front>
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<DateCreated><Year>2016</Year>
<Month>05</Month>
<Day>04</Day>
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<ArticleTitle>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.</ArticleTitle>
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<Abstract><AbstractText>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.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Hochhaus</LastName>
<ForeName>A</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Abteilung Hämatologie/Onkologie, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Saglio</LastName>
<ForeName>G</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>Division of Internal Medicine & Hematology, University of Turin, Orbassano, Italy.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Hughes</LastName>
<ForeName>T P</ForeName>
<Initials>TP</Initials>
<AffiliationInfo><Affiliation>South Australian Health and Medical Research Institute (SAHMRI), University of Adelaide, SA Pathology, Adelaide, South Australia, Australia.</Affiliation>
</AffiliationInfo>
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<ForeName>R A</ForeName>
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<Author ValidYN="Y"><LastName>Kim</LastName>
<ForeName>D-W</ForeName>
<Initials>DW</Initials>
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</AffiliationInfo>
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<ForeName>P D</ForeName>
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<AffiliationInfo><Affiliation>Charité-Universitätsmedizin Berlin, Berlin, Germany.</Affiliation>
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<Author ValidYN="Y"><LastName>Etienne</LastName>
<ForeName>G</ForeName>
<Initials>G</Initials>
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</AffiliationInfo>
</Author>
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<ForeName>P E</ForeName>
<Initials>PE</Initials>
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<ForeName>I W</ForeName>
<Initials>IW</Initials>
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</AffiliationInfo>
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<ForeName>H</ForeName>
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</AffiliationInfo>
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<ForeName>B</ForeName>
<Initials>B</Initials>
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</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Deng</LastName>
<ForeName>W</ForeName>
<Initials>W</Initials>
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<Author ValidYN="Y"><LastName>Dalal</LastName>
<ForeName>D</ForeName>
<Initials>D</Initials>
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</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Menssen</LastName>
<ForeName>H D</ForeName>
<Initials>HD</Initials>
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</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Kantarjian</LastName>
<ForeName>H M</ForeName>
<Initials>HM</Initials>
<AffiliationInfo><Affiliation>The University of Texas MD Anderson Cancer Center, Houston, TX, USA.</Affiliation>
</AffiliationInfo>
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