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 : 003092 ( Ncbi/Merge ); précédent : 003091; suivant : 003093Long-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 [Allemagne] ; G. Saglio [Italie] ; T P Hughes [Australie] ; R A Larson [États-Unis] ; D-W Kim [Corée du Sud] ; S. Issaragrisil [Thaïlande] ; P D Le Coutre [Allemagne] ; G. Etienne [France] ; P E Dorlhiac-Llacer [Brésil] ; R E Clark [Royaume-Uni] ; I W Flinn [États-Unis] ; H. Nakamae [Japon] ; B. Donohue [États-Unis] ; W. Deng [États-Unis] ; D. Dalal [États-Unis] ; H D Menssen [Suisse] ; H M Kantarjian [États-Unis]Source :
- Leukemia [ 0887-6924 ] ; 2016.
Descripteurs français
- KwdFr :
- Cholestérol (sang), Glycémie (métabolisme), Humains, Leucémie myéloïde chronique BCR-ABL positive (mortalité), Leucémie myéloïde chronique BCR-ABL positive (sang), Leucémie myéloïde chronique BCR-ABL positive (traitement médicamenteux), Leucémie myéloïde en phase chronique (mortalité), Leucémie myéloïde en phase chronique (sang), Leucémie myéloïde en phase chronique (traitement médicamenteux), Mésylate d'imatinib (administration et posologie), Mésylate d'imatinib (pharmacologie), Pyrimidines (administration et posologie), Pyrimidines (pharmacologie), Résultat thérapeutique, Études de suivi, Évaluation des risques.
- MESH :
- administration et posologie : Mésylate d'imatinib, Pyrimidines.
- mortalité : Leucémie myéloïde chronique BCR-ABL positive, Leucémie myéloïde en phase chronique.
- métabolisme : Glycémie.
- pharmacologie : Mésylate d'imatinib, Pyrimidines.
- sang : Cholestérol, Leucémie myéloïde chronique BCR-ABL positive, Leucémie myéloïde en phase chronique.
- traitement médicamenteux : Leucémie myéloïde chronique BCR-ABL positive, Leucémie myéloïde en phase chronique.
- Humains, Résultat thérapeutique, Études de suivi, Évaluation des risques.
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 (MR4.5;
Url:
DOI: 10.1038/leu.2016.5
PubMed: 26837842
PubMed Central: 4858585
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Hochhaus</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>Abteilung Hämatologie/Onkologie, Klinik für Innere Medizin II, Universitätsklinikum Jena</institution>, Jena,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Saglio, G" sort="Saglio, G" uniqKey="Saglio G" first="G" last="Saglio">G. Saglio</name><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>Division of Internal Medicine & Hematology, University of Turin</institution>, Orbassano,<country>Italy</country></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Hughes, T P" sort="Hughes, T P" uniqKey="Hughes T" first="T P" last="Hughes">T P Hughes</name><affiliation wicri:level="1"><nlm:aff id="aff3"><institution>South Australian Health and Medical Research Institute (SAHMRI), University of Adelaide, SA Pathology</institution>, Adelaide, South Australia,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Larson, R A" sort="Larson, R A" uniqKey="Larson R" first="R A" last="Larson">R A Larson</name><affiliation wicri:level="1"><nlm:aff id="aff4"><institution>Department of Medicine, The University of Chicago</institution>, Chicago, IL,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kim, D W" sort="Kim, D W" uniqKey="Kim D" first="D-W" last="Kim">D-W Kim</name><affiliation wicri:level="1"><nlm:aff id="aff5"><institution>Leukemia Research Institute, Seoul St Mary's Hospital, The Catholic University of Korea</institution>, Seoul,<country>Korea</country></nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Issaragrisil, S" sort="Issaragrisil, S" uniqKey="Issaragrisil S" first="S" last="Issaragrisil">S. Issaragrisil</name><affiliation wicri:level="1"><nlm:aff id="aff6"><institution>Faculty of Medicine Siriraj Hospital, Mahidol University</institution>, Bangkok,<country>Thailand</country></nlm:aff><country xml:lang="fr">Thaïlande</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Le Coutre, P D" sort="Le Coutre, P D" uniqKey="Le Coutre P" first="P D" last="Le Coutre">P D Le Coutre</name><affiliation wicri:level="1"><nlm:aff id="aff7"><institution>Charité—Universitätsmedizin Berlin</institution>, Berlin,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Etienne, G" sort="Etienne, G" uniqKey="Etienne G" first="G" last="Etienne">G. Etienne</name><affiliation wicri:level="1"><nlm:aff id="aff8"><institution>Centre Régional de Lutte Contre le Cancer de Bordeaux et du Sud-Ouest, Institut Bergonié, Département d'Oncologie Médicale</institution>, Bordeaux,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Dorlhiac Llacer, P E" sort="Dorlhiac Llacer, P E" uniqKey="Dorlhiac Llacer P" first="P E" last="Dorlhiac-Llacer">P E Dorlhiac-Llacer</name><affiliation wicri:level="1"><nlm:aff id="aff9"><institution>Hospital das Clinicas FMUSP</institution>, São Paulo,<country>Brazil</country></nlm:aff><country xml:lang="fr">Brésil</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Clark, R E" sort="Clark, R E" uniqKey="Clark R" first="R E" last="Clark">R E Clark</name><affiliation wicri:level="1"><nlm:aff id="aff10"><institution>Royal Liverpool University Hospital</institution>, Liverpool,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Flinn, I W" sort="Flinn, I W" uniqKey="Flinn I" first="I W" last="Flinn">I W Flinn</name><affiliation wicri:level="1"><nlm:aff id="aff11"><institution>Sarah Cannon Research Institute</institution>, Nashville, TN,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Nakamae, H" sort="Nakamae, H" uniqKey="Nakamae H" first="H" last="Nakamae">H. Nakamae</name><affiliation wicri:level="1"><nlm:aff id="aff12"><institution>Department of Hematology, Osaka City University</institution>, Osaka,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Donohue, B" sort="Donohue, B" uniqKey="Donohue B" first="B" last="Donohue">B. Donohue</name><affiliation wicri:level="1"><nlm:aff id="aff13"><institution>Novartis Pharmaceuticals Corporation</institution>, East Hanover, NJ,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Deng, W" sort="Deng, W" uniqKey="Deng W" first="W" last="Deng">W. Deng</name><affiliation wicri:level="1"><nlm:aff id="aff13"><institution>Novartis Pharmaceuticals Corporation</institution>, East Hanover, NJ,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Dalal, D" sort="Dalal, D" uniqKey="Dalal D" first="D" last="Dalal">D. Dalal</name><affiliation wicri:level="1"><nlm:aff id="aff13"><institution>Novartis Pharmaceuticals Corporation</institution>, East Hanover, NJ,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Menssen, H D" sort="Menssen, H D" uniqKey="Menssen H" first="H D" last="Menssen">H D Menssen</name><affiliation wicri:level="1"><nlm:aff id="aff14"><institution>Novartis Pharma AG</institution>, Basel,<country>Switzerland</country></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kantarjian, H M" sort="Kantarjian, H M" uniqKey="Kantarjian H" first="H M" last="Kantarjian">H M Kantarjian</name><affiliation wicri:level="1"><nlm:aff id="aff15"><institution>The University of Texas MD Anderson Cancer Center</institution>, Houston, TX,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">Leukemia</title><idno type="ISSN">0887-6924</idno><idno type="eISSN">1476-5551</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Blood Glucose (metabolism)</term><term>Cholesterol (blood)</term><term>Follow-Up Studies</term><term>Humans</term><term>Imatinib Mesylate (administration & dosage)</term><term>Imatinib Mesylate (pharmacology)</term><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive (blood)</term><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive (drug therapy)</term><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive (mortality)</term><term>Leukemia, Myeloid, Chronic-Phase (blood)</term><term>Leukemia, Myeloid, Chronic-Phase (drug 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thérapeutique</term><term>Études de suivi</term><term>Évaluation des risques</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Imatinib Mesylate</term><term>Pyrimidines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Cholesterol</term></keywords><keywords scheme="MESH" type="chemical" qualifier="metabolism" xml:lang="en"><term>Blood Glucose</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacology" xml:lang="en"><term>Imatinib Mesylate</term><term>Pyrimidines</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Mésylate d'imatinib</term><term>Pyrimidines</term></keywords><keywords scheme="MESH" qualifier="blood" xml:lang="en"><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</term><term>Leukemia, Myeloid, Chronic-Phase</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</term><term>Leukemia, Myeloid, Chronic-Phase</term></keywords><keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</term><term>Leukemia, Myeloid, Chronic-Phase</term></keywords><keywords scheme="MESH" qualifier="mortalité" xml:lang="fr"><term>Leucémie myéloïde chronique BCR-ABL positive</term><term>Leucémie myéloïde en phase chronique</term></keywords><keywords scheme="MESH" qualifier="métabolisme" xml:lang="fr"><term>Glycémie</term></keywords><keywords scheme="MESH" qualifier="pharmacologie" xml:lang="fr"><term>Mésylate d'imatinib</term><term>Pyrimidines</term></keywords><keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Cholestérol</term><term>Leucémie myéloïde chronique BCR-ABL positive</term><term>Leucémie myéloïde en phase chronique</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Leucémie myéloïde chronique BCR-ABL positive</term><term>Leucémie myéloïde en phase chronique</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Follow-Up Studies</term><term>Humans</term><term>Risk Assessment</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Humains</term><term>Résultat thérapeutique</term><term>Études de suivi</term><term>Évaluation des risques</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>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<sup>4.5</sup>; <italic>BCR-ABL</italic>⩽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.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><double pmid="26837842"><pmc><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">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</title><author><name sortKey="Hochhaus, A" sort="Hochhaus, A" uniqKey="Hochhaus A" first="A" last="Hochhaus">A. Hochhaus</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>Abteilung Hämatologie/Onkologie, Klinik für Innere Medizin II, Universitätsklinikum Jena</institution>, Jena,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Saglio, G" sort="Saglio, G" uniqKey="Saglio G" first="G" last="Saglio">G. Saglio</name><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>Division of Internal Medicine & Hematology, University of Turin</institution>, Orbassano,<country>Italy</country></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Hughes, T P" sort="Hughes, T P" uniqKey="Hughes T" first="T P" last="Hughes">T P Hughes</name><affiliation wicri:level="1"><nlm:aff id="aff3"><institution>South Australian Health and Medical Research Institute (SAHMRI), University of Adelaide, SA Pathology</institution>, Adelaide, South Australia,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Larson, R A" sort="Larson, R A" uniqKey="Larson R" first="R A" last="Larson">R A Larson</name><affiliation wicri:level="1"><nlm:aff id="aff4"><institution>Department of Medicine, The University of Chicago</institution>, Chicago, IL,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kim, D W" sort="Kim, D W" uniqKey="Kim D" first="D-W" last="Kim">D-W Kim</name><affiliation wicri:level="1"><nlm:aff id="aff5"><institution>Leukemia Research Institute, Seoul St Mary's Hospital, The Catholic University of Korea</institution>, Seoul,<country>Korea</country></nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Issaragrisil, S" sort="Issaragrisil, S" uniqKey="Issaragrisil S" first="S" last="Issaragrisil">S. Issaragrisil</name><affiliation wicri:level="1"><nlm:aff id="aff6"><institution>Faculty of Medicine Siriraj Hospital, Mahidol University</institution>, Bangkok,<country>Thailand</country></nlm:aff><country xml:lang="fr">Thaïlande</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Le Coutre, P D" sort="Le Coutre, P D" uniqKey="Le Coutre P" first="P D" last="Le Coutre">P D Le Coutre</name><affiliation wicri:level="1"><nlm:aff id="aff7"><institution>Charité—Universitätsmedizin Berlin</institution>, Berlin,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Etienne, G" sort="Etienne, G" uniqKey="Etienne G" first="G" last="Etienne">G. Etienne</name><affiliation wicri:level="1"><nlm:aff id="aff8"><institution>Centre Régional de Lutte Contre le Cancer de Bordeaux et du Sud-Ouest, Institut Bergonié, Département d'Oncologie Médicale</institution>, Bordeaux,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Dorlhiac Llacer, P E" sort="Dorlhiac Llacer, P E" uniqKey="Dorlhiac Llacer P" first="P E" last="Dorlhiac-Llacer">P E Dorlhiac-Llacer</name><affiliation wicri:level="1"><nlm:aff id="aff9"><institution>Hospital das Clinicas FMUSP</institution>, São Paulo,<country>Brazil</country></nlm:aff><country xml:lang="fr">Brésil</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Clark, R E" sort="Clark, R E" uniqKey="Clark R" first="R E" last="Clark">R E Clark</name><affiliation wicri:level="1"><nlm:aff id="aff10"><institution>Royal Liverpool University Hospital</institution>, Liverpool,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Flinn, I W" sort="Flinn, I W" uniqKey="Flinn I" first="I W" last="Flinn">I W Flinn</name><affiliation wicri:level="1"><nlm:aff id="aff11"><institution>Sarah Cannon Research Institute</institution>, Nashville, TN,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Nakamae, H" sort="Nakamae, H" uniqKey="Nakamae H" first="H" last="Nakamae">H. Nakamae</name><affiliation wicri:level="1"><nlm:aff id="aff12"><institution>Department of Hematology, Osaka City University</institution>, Osaka,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Donohue, B" sort="Donohue, B" uniqKey="Donohue B" first="B" last="Donohue">B. Donohue</name><affiliation wicri:level="1"><nlm:aff id="aff13"><institution>Novartis Pharmaceuticals Corporation</institution>, East Hanover, NJ,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Deng, W" sort="Deng, W" uniqKey="Deng W" first="W" last="Deng">W. Deng</name><affiliation wicri:level="1"><nlm:aff id="aff13"><institution>Novartis Pharmaceuticals Corporation</institution>, East Hanover, NJ,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Dalal, D" sort="Dalal, D" uniqKey="Dalal D" first="D" last="Dalal">D. Dalal</name><affiliation wicri:level="1"><nlm:aff id="aff13"><institution>Novartis Pharmaceuticals Corporation</institution>, East Hanover, NJ,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Menssen, H D" sort="Menssen, H D" uniqKey="Menssen H" first="H D" last="Menssen">H D Menssen</name><affiliation wicri:level="1"><nlm:aff id="aff14"><institution>Novartis Pharma AG</institution>, Basel,<country>Switzerland</country></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kantarjian, H M" sort="Kantarjian, H M" uniqKey="Kantarjian H" first="H M" last="Kantarjian">H M Kantarjian</name><affiliation wicri:level="1"><nlm:aff id="aff15"><institution>The University of Texas MD Anderson Cancer Center</institution>, Houston, TX,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">26837842</idno><idno type="pmc">4858585</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4858585</idno><idno type="RBID">PMC:4858585</idno><idno type="doi">10.1038/leu.2016.5</idno><date when="2016">2016</date><idno type="wicri:Area/Pmc/Corpus">000726</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000726</idno><idno type="wicri:Area/Pmc/Curation">000725</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000725</idno><idno type="wicri:Area/Pmc/Checkpoint">000804</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">000804</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">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</title><author><name sortKey="Hochhaus, A" sort="Hochhaus, A" uniqKey="Hochhaus A" first="A" last="Hochhaus">A. Hochhaus</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>Abteilung Hämatologie/Onkologie, Klinik für Innere Medizin II, Universitätsklinikum Jena</institution>, Jena,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Saglio, G" sort="Saglio, G" uniqKey="Saglio G" first="G" last="Saglio">G. Saglio</name><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>Division of Internal Medicine & Hematology, University of Turin</institution>, Orbassano,<country>Italy</country></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Hughes, T P" sort="Hughes, T P" uniqKey="Hughes T" first="T P" last="Hughes">T P Hughes</name><affiliation wicri:level="1"><nlm:aff id="aff3"><institution>South Australian Health and Medical Research Institute (SAHMRI), University of Adelaide, SA Pathology</institution>, Adelaide, South Australia,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Larson, R A" sort="Larson, R A" uniqKey="Larson R" first="R A" last="Larson">R A Larson</name><affiliation wicri:level="1"><nlm:aff id="aff4"><institution>Department of Medicine, The University of Chicago</institution>, Chicago, IL,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kim, D W" sort="Kim, D W" uniqKey="Kim D" first="D-W" last="Kim">D-W Kim</name><affiliation wicri:level="1"><nlm:aff id="aff5"><institution>Leukemia Research Institute, Seoul St Mary's Hospital, The Catholic University of Korea</institution>, Seoul,<country>Korea</country></nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Issaragrisil, S" sort="Issaragrisil, S" uniqKey="Issaragrisil S" first="S" last="Issaragrisil">S. Issaragrisil</name><affiliation wicri:level="1"><nlm:aff id="aff6"><institution>Faculty of Medicine Siriraj Hospital, Mahidol University</institution>, Bangkok,<country>Thailand</country></nlm:aff><country xml:lang="fr">Thaïlande</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Le Coutre, P D" sort="Le Coutre, P D" uniqKey="Le Coutre P" first="P D" last="Le Coutre">P D Le Coutre</name><affiliation wicri:level="1"><nlm:aff id="aff7"><institution>Charité—Universitätsmedizin Berlin</institution>, Berlin,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Etienne, G" sort="Etienne, G" uniqKey="Etienne G" first="G" last="Etienne">G. Etienne</name><affiliation wicri:level="1"><nlm:aff id="aff8"><institution>Centre Régional de Lutte Contre le Cancer de Bordeaux et du Sud-Ouest, Institut Bergonié, Département d'Oncologie Médicale</institution>, Bordeaux,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Dorlhiac Llacer, P E" sort="Dorlhiac Llacer, P E" uniqKey="Dorlhiac Llacer P" first="P E" last="Dorlhiac-Llacer">P E Dorlhiac-Llacer</name><affiliation wicri:level="1"><nlm:aff id="aff9"><institution>Hospital das Clinicas FMUSP</institution>, São Paulo,<country>Brazil</country></nlm:aff><country xml:lang="fr">Brésil</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Clark, R E" sort="Clark, R E" uniqKey="Clark R" first="R E" last="Clark">R E Clark</name><affiliation wicri:level="1"><nlm:aff id="aff10"><institution>Royal Liverpool University Hospital</institution>, Liverpool,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Flinn, I W" sort="Flinn, I W" uniqKey="Flinn I" first="I W" last="Flinn">I W Flinn</name><affiliation wicri:level="1"><nlm:aff id="aff11"><institution>Sarah Cannon Research Institute</institution>, Nashville, TN,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Nakamae, H" sort="Nakamae, H" uniqKey="Nakamae H" first="H" last="Nakamae">H. Nakamae</name><affiliation wicri:level="1"><nlm:aff id="aff12"><institution>Department of Hematology, Osaka City University</institution>, Osaka,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Donohue, B" sort="Donohue, B" uniqKey="Donohue B" first="B" last="Donohue">B. Donohue</name><affiliation wicri:level="1"><nlm:aff id="aff13"><institution>Novartis Pharmaceuticals Corporation</institution>, East Hanover, NJ,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Deng, W" sort="Deng, W" uniqKey="Deng W" first="W" last="Deng">W. Deng</name><affiliation wicri:level="1"><nlm:aff id="aff13"><institution>Novartis Pharmaceuticals Corporation</institution>, East Hanover, NJ,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Dalal, D" sort="Dalal, D" uniqKey="Dalal D" first="D" last="Dalal">D. Dalal</name><affiliation wicri:level="1"><nlm:aff id="aff13"><institution>Novartis Pharmaceuticals Corporation</institution>, East Hanover, NJ,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Menssen, H D" sort="Menssen, H D" uniqKey="Menssen H" first="H D" last="Menssen">H D Menssen</name><affiliation wicri:level="1"><nlm:aff id="aff14"><institution>Novartis Pharma AG</institution>, Basel,<country>Switzerland</country></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kantarjian, H M" sort="Kantarjian, H M" uniqKey="Kantarjian H" first="H M" last="Kantarjian">H M Kantarjian</name><affiliation wicri:level="1"><nlm:aff id="aff15"><institution>The University of Texas MD Anderson Cancer Center</institution>, Houston, TX,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">Leukemia</title><idno type="ISSN">0887-6924</idno><idno type="eISSN">1476-5551</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>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<sup>4.5</sup>; <italic>BCR-ABL</italic>⩽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.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI></pmc><pubmed><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">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.</title><author><name sortKey="Hochhaus, A" sort="Hochhaus, A" uniqKey="Hochhaus A" first="A" last="Hochhaus">A. Hochhaus</name><affiliation wicri:level="1"><nlm:affiliation>Abteilung Hämatologie/Onkologie, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Abteilung Hämatologie/Onkologie, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena</wicri:regionArea><wicri:noRegion>Jena</wicri:noRegion><wicri:noRegion>Jena</wicri:noRegion><wicri:noRegion>Jena</wicri:noRegion></affiliation></author><author><name sortKey="Saglio, G" sort="Saglio, G" uniqKey="Saglio G" first="G" last="Saglio">G. Saglio</name><affiliation wicri:level="1"><nlm:affiliation>Division of Internal Medicine & Hematology, University of Turin, Orbassano, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Division of Internal Medicine & Hematology, University of Turin, Orbassano</wicri:regionArea><wicri:noRegion>Orbassano</wicri:noRegion></affiliation></author><author><name sortKey="Hughes, T P" sort="Hughes, T P" uniqKey="Hughes T" first="T P" last="Hughes">T P Hughes</name><affiliation wicri:level="1"><nlm:affiliation>South Australian Health and Medical Research Institute (SAHMRI), University of Adelaide, SA Pathology, Adelaide, South Australia, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>South Australian Health and Medical Research Institute (SAHMRI), University of Adelaide, SA Pathology, Adelaide, South Australia</wicri:regionArea><wicri:noRegion>South Australia</wicri:noRegion></affiliation></author><author><name sortKey="Larson, R A" sort="Larson, R A" uniqKey="Larson R" first="R A" last="Larson">R A Larson</name><affiliation wicri:level="2"><nlm:affiliation>Department of Medicine, The University of Chicago, Chicago, IL, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine, The University of Chicago, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Kim, D W" sort="Kim, D W" uniqKey="Kim D" first="D-W" last="Kim">D-W Kim</name><affiliation wicri:level="3"><nlm:affiliation>Leukemia Research Institute, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, Korea.</nlm:affiliation><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>Leukemia Research Institute, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul</wicri:regionArea><placeName><settlement type="city">Séoul</settlement><region type="capital">Région capitale de Séoul</region></placeName></affiliation></author><author><name sortKey="Issaragrisil, S" sort="Issaragrisil, S" uniqKey="Issaragrisil S" first="S" last="Issaragrisil">S. Issaragrisil</name><affiliation wicri:level="1"><nlm:affiliation>Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.</nlm:affiliation><country xml:lang="fr">Thaïlande</country><wicri:regionArea>Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok</wicri:regionArea><wicri:noRegion>Bangkok</wicri:noRegion></affiliation></author><author><name sortKey="Le Coutre, P D" sort="Le Coutre, P D" uniqKey="Le Coutre P" first="P D" last="Le Coutre">P D Le Coutre</name><affiliation wicri:level="3"><nlm:affiliation>Charité-Universitätsmedizin Berlin, Berlin, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Charité-Universitätsmedizin Berlin, Berlin</wicri:regionArea><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Etienne, G" sort="Etienne, G" uniqKey="Etienne G" first="G" last="Etienne">G. Etienne</name><affiliation wicri:level="3"><nlm:affiliation>Centre Régional de Lutte Contre le Cancer de Bordeaux et du Sud-Ouest, Institut Bergonié, Département d'Oncologie Médicale, Bordeaux, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Centre Régional de Lutte Contre le Cancer de Bordeaux et du Sud-Ouest, Institut Bergonié, Département d'Oncologie Médicale, Bordeaux</wicri:regionArea><placeName><region type="region">Nouvelle-Aquitaine</region><region type="old region">Aquitaine</region><settlement type="city">Bordeaux</settlement></placeName></affiliation></author><author><name sortKey="Dorlhiac Llacer, P E" sort="Dorlhiac Llacer, P E" uniqKey="Dorlhiac Llacer P" first="P E" last="Dorlhiac-Llacer">P E Dorlhiac-Llacer</name><affiliation wicri:level="3"><nlm:affiliation>Hospital das Clinicas FMUSP, São Paulo, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Hospital das Clinicas FMUSP, São Paulo</wicri:regionArea><placeName><settlement type="city">São Paulo</settlement><region type="state">État de São Paulo</region></placeName></affiliation></author><author><name sortKey="Clark, R E" sort="Clark, R E" uniqKey="Clark R" first="R E" last="Clark">R E Clark</name><affiliation wicri:level="1"><nlm:affiliation>Royal Liverpool University Hospital, Liverpool, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Royal Liverpool University Hospital, Liverpool</wicri:regionArea><wicri:noRegion>Liverpool</wicri:noRegion></affiliation></author><author><name sortKey="Flinn, I W" sort="Flinn, I W" uniqKey="Flinn I" first="I W" last="Flinn">I W Flinn</name><affiliation wicri:level="2"><nlm:affiliation>Sarah Cannon Research Institute, Nashville, TN, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Sarah Cannon Research Institute, Nashville, TN</wicri:regionArea><placeName><region type="state">Tennessee</region></placeName></affiliation></author><author><name sortKey="Nakamae, H" sort="Nakamae, H" uniqKey="Nakamae H" first="H" last="Nakamae">H. Nakamae</name><affiliation wicri:level="1"><nlm:affiliation>Department of Hematology, Osaka City University, Osaka, Japan.</nlm:affiliation><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Hematology, Osaka City University, Osaka</wicri:regionArea><wicri:noRegion>Osaka</wicri:noRegion></affiliation></author><author><name sortKey="Donohue, B" sort="Donohue, B" uniqKey="Donohue B" first="B" last="Donohue">B. Donohue</name><affiliation wicri:level="2"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Deng, W" sort="Deng, W" uniqKey="Deng W" first="W" last="Deng">W. Deng</name><affiliation wicri:level="2"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Dalal, D" sort="Dalal, D" uniqKey="Dalal D" first="D" last="Dalal">D. Dalal</name><affiliation wicri:level="2"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Menssen, H D" sort="Menssen, H D" uniqKey="Menssen H" first="H D" last="Menssen">H D Menssen</name><affiliation wicri:level="1"><nlm:affiliation>Novartis Pharma AG, Basel, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>Novartis Pharma AG, Basel</wicri:regionArea><wicri:noRegion>Basel</wicri:noRegion></affiliation></author><author><name sortKey="Kantarjian, H M" sort="Kantarjian, H M" uniqKey="Kantarjian H" first="H M" last="Kantarjian">H M Kantarjian</name><affiliation wicri:level="2"><nlm:affiliation>The University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>The University of Texas MD Anderson Cancer Center, Houston, TX</wicri:regionArea><placeName><region type="state">Texas</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:26837842</idno><idno type="pmid">26837842</idno><idno type="doi">10.1038/leu.2016.5</idno><idno type="wicri:Area/PubMed/Corpus">001E87</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001E87</idno><idno type="wicri:Area/PubMed/Curation">001E63</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">001E63</idno><idno type="wicri:Area/PubMed/Checkpoint">001E63</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">001E63</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">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.</title><author><name sortKey="Hochhaus, A" sort="Hochhaus, A" uniqKey="Hochhaus A" first="A" last="Hochhaus">A. Hochhaus</name><affiliation wicri:level="1"><nlm:affiliation>Abteilung Hämatologie/Onkologie, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Abteilung Hämatologie/Onkologie, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena</wicri:regionArea><wicri:noRegion>Jena</wicri:noRegion><wicri:noRegion>Jena</wicri:noRegion><wicri:noRegion>Jena</wicri:noRegion></affiliation></author><author><name sortKey="Saglio, G" sort="Saglio, G" uniqKey="Saglio G" first="G" last="Saglio">G. Saglio</name><affiliation wicri:level="1"><nlm:affiliation>Division of Internal Medicine & Hematology, University of Turin, Orbassano, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Division of Internal Medicine & Hematology, University of Turin, Orbassano</wicri:regionArea><wicri:noRegion>Orbassano</wicri:noRegion></affiliation></author><author><name sortKey="Hughes, T P" sort="Hughes, T P" uniqKey="Hughes T" first="T P" last="Hughes">T P Hughes</name><affiliation wicri:level="1"><nlm:affiliation>South Australian Health and Medical Research Institute (SAHMRI), University of Adelaide, SA Pathology, Adelaide, South Australia, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>South Australian Health and Medical Research Institute (SAHMRI), University of Adelaide, SA Pathology, Adelaide, South Australia</wicri:regionArea><wicri:noRegion>South Australia</wicri:noRegion></affiliation></author><author><name sortKey="Larson, R A" sort="Larson, R A" uniqKey="Larson R" first="R A" last="Larson">R A Larson</name><affiliation wicri:level="2"><nlm:affiliation>Department of Medicine, The University of Chicago, Chicago, IL, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine, The University of Chicago, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Kim, D W" sort="Kim, D W" uniqKey="Kim D" first="D-W" last="Kim">D-W Kim</name><affiliation wicri:level="3"><nlm:affiliation>Leukemia Research Institute, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, Korea.</nlm:affiliation><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>Leukemia Research Institute, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul</wicri:regionArea><placeName><settlement type="city">Séoul</settlement><region type="capital">Région capitale de Séoul</region></placeName></affiliation></author><author><name sortKey="Issaragrisil, S" sort="Issaragrisil, S" uniqKey="Issaragrisil S" first="S" last="Issaragrisil">S. Issaragrisil</name><affiliation wicri:level="1"><nlm:affiliation>Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.</nlm:affiliation><country xml:lang="fr">Thaïlande</country><wicri:regionArea>Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok</wicri:regionArea><wicri:noRegion>Bangkok</wicri:noRegion></affiliation></author><author><name sortKey="Le Coutre, P D" sort="Le Coutre, P D" uniqKey="Le Coutre P" first="P D" last="Le Coutre">P D Le Coutre</name><affiliation wicri:level="3"><nlm:affiliation>Charité-Universitätsmedizin Berlin, Berlin, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Charité-Universitätsmedizin Berlin, Berlin</wicri:regionArea><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Etienne, G" sort="Etienne, G" uniqKey="Etienne G" first="G" last="Etienne">G. Etienne</name><affiliation wicri:level="3"><nlm:affiliation>Centre Régional de Lutte Contre le Cancer de Bordeaux et du Sud-Ouest, Institut Bergonié, Département d'Oncologie Médicale, Bordeaux, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Centre Régional de Lutte Contre le Cancer de Bordeaux et du Sud-Ouest, Institut Bergonié, Département d'Oncologie Médicale, Bordeaux</wicri:regionArea><placeName><region type="region">Nouvelle-Aquitaine</region><region type="old region">Aquitaine</region><settlement type="city">Bordeaux</settlement></placeName></affiliation></author><author><name sortKey="Dorlhiac Llacer, P E" sort="Dorlhiac Llacer, P E" uniqKey="Dorlhiac Llacer P" first="P E" last="Dorlhiac-Llacer">P E Dorlhiac-Llacer</name><affiliation wicri:level="3"><nlm:affiliation>Hospital das Clinicas FMUSP, São Paulo, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Hospital das Clinicas FMUSP, São Paulo</wicri:regionArea><placeName><settlement type="city">São Paulo</settlement><region type="state">État de São Paulo</region></placeName></affiliation></author><author><name sortKey="Clark, R E" sort="Clark, R E" uniqKey="Clark R" first="R E" last="Clark">R E Clark</name><affiliation wicri:level="1"><nlm:affiliation>Royal Liverpool University Hospital, Liverpool, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Royal Liverpool University Hospital, Liverpool</wicri:regionArea><wicri:noRegion>Liverpool</wicri:noRegion></affiliation></author><author><name sortKey="Flinn, I W" sort="Flinn, I W" uniqKey="Flinn I" first="I W" last="Flinn">I W Flinn</name><affiliation wicri:level="2"><nlm:affiliation>Sarah Cannon Research Institute, Nashville, TN, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Sarah Cannon Research Institute, Nashville, TN</wicri:regionArea><placeName><region type="state">Tennessee</region></placeName></affiliation></author><author><name sortKey="Nakamae, H" sort="Nakamae, H" uniqKey="Nakamae H" first="H" last="Nakamae">H. Nakamae</name><affiliation wicri:level="1"><nlm:affiliation>Department of Hematology, Osaka City University, Osaka, Japan.</nlm:affiliation><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Hematology, Osaka City University, Osaka</wicri:regionArea><wicri:noRegion>Osaka</wicri:noRegion></affiliation></author><author><name sortKey="Donohue, B" sort="Donohue, B" uniqKey="Donohue B" first="B" last="Donohue">B. Donohue</name><affiliation wicri:level="2"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Deng, W" sort="Deng, W" uniqKey="Deng W" first="W" last="Deng">W. Deng</name><affiliation wicri:level="2"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Dalal, D" sort="Dalal, D" uniqKey="Dalal D" first="D" last="Dalal">D. Dalal</name><affiliation wicri:level="2"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Menssen, H D" sort="Menssen, H D" uniqKey="Menssen H" first="H D" last="Menssen">H D Menssen</name><affiliation wicri:level="1"><nlm:affiliation>Novartis Pharma AG, Basel, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>Novartis Pharma AG, Basel</wicri:regionArea><wicri:noRegion>Basel</wicri:noRegion></affiliation></author><author><name sortKey="Kantarjian, H M" sort="Kantarjian, H M" uniqKey="Kantarjian H" first="H M" last="Kantarjian">H M Kantarjian</name><affiliation wicri:level="2"><nlm:affiliation>The University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>The University of Texas MD Anderson Cancer Center, Houston, TX</wicri:regionArea><placeName><region type="state">Texas</region></placeName></affiliation></author></analytic><series><title level="j">Leukemia</title><idno type="eISSN">1476-5551</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Blood Glucose (metabolism)</term><term>Cholesterol (blood)</term><term>Follow-Up Studies</term><term>Humans</term><term>Imatinib Mesylate (administration & dosage)</term><term>Imatinib Mesylate (pharmacology)</term><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive (blood)</term><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive (drug therapy)</term><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive (mortality)</term><term>Leukemia, Myeloid, Chronic-Phase (blood)</term><term>Leukemia, Myeloid, Chronic-Phase (drug therapy)</term><term>Leukemia, Myeloid, Chronic-Phase (mortality)</term><term>Pyrimidines (administration & dosage)</term><term>Pyrimidines (pharmacology)</term><term>Risk Assessment</term><term>Treatment Outcome</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Cholestérol (sang)</term><term>Glycémie (métabolisme)</term><term>Humains</term><term>Leucémie myéloïde chronique BCR-ABL positive (mortalité)</term><term>Leucémie myéloïde chronique BCR-ABL positive (sang)</term><term>Leucémie myéloïde chronique BCR-ABL positive (traitement médicamenteux)</term><term>Leucémie myéloïde en phase chronique (mortalité)</term><term>Leucémie myéloïde en phase chronique (sang)</term><term>Leucémie myéloïde en phase chronique (traitement médicamenteux)</term><term>Mésylate d'imatinib (administration et posologie)</term><term>Mésylate d'imatinib (pharmacologie)</term><term>Pyrimidines (administration et posologie)</term><term>Pyrimidines (pharmacologie)</term><term>Résultat thérapeutique</term><term>Études de suivi</term><term>Évaluation des risques</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Imatinib Mesylate</term><term>Pyrimidines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Cholesterol</term></keywords><keywords scheme="MESH" type="chemical" qualifier="metabolism" xml:lang="en"><term>Blood Glucose</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacology" xml:lang="en"><term>Imatinib Mesylate</term><term>Pyrimidines</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Mésylate d'imatinib</term><term>Pyrimidines</term></keywords><keywords scheme="MESH" qualifier="blood" xml:lang="en"><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</term><term>Leukemia, Myeloid, Chronic-Phase</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</term><term>Leukemia, Myeloid, Chronic-Phase</term></keywords><keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</term><term>Leukemia, Myeloid, Chronic-Phase</term></keywords><keywords scheme="MESH" qualifier="mortalité" xml:lang="fr"><term>Leucémie myéloïde chronique BCR-ABL positive</term><term>Leucémie myéloïde en phase chronique</term></keywords><keywords scheme="MESH" qualifier="métabolisme" xml:lang="fr"><term>Glycémie</term></keywords><keywords scheme="MESH" qualifier="pharmacologie" xml:lang="fr"><term>Mésylate d'imatinib</term><term>Pyrimidines</term></keywords><keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Cholestérol</term><term>Leucémie myéloïde chronique BCR-ABL positive</term><term>Leucémie myéloïde en phase chronique</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Leucémie myéloïde chronique BCR-ABL positive</term><term>Leucémie myéloïde en phase chronique</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Follow-Up Studies</term><term>Humans</term><term>Risk Assessment</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Humains</term><term>Résultat thérapeutique</term><term>Études de suivi</term><term>Évaluation des risques</term></keywords></textClass></profileDesc></teiHeader><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></TEI></pubmed></double></record>Pour manipuler ce document sous Unix (Dilib)
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HfdIndexSelect -h $EXPLOR_AREA/Data/Ncbi/Merge/RBID.i -Sk "pubmed:26837842" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Ncbi/Merge/biblio.hfd \
| NlmPubMed2Wicri -a AustralieFrV1
| This area was generated with Dilib version V0.6.33. |  |