A phase 2 study of MK-0457 in patients with BCR-ABL T315I mutant chronic myelogenous leukemia and philadelphia chromosome-positive acute lymphoblastic leukemia
Identifieur interne : 001D18 ( Ncbi/Curation ); précédent : 001D17; suivant : 001D19A phase 2 study of MK-0457 in patients with BCR-ABL T315I mutant chronic myelogenous leukemia and philadelphia chromosome-positive acute lymphoblastic leukemia
Auteurs : J F Seymour [Australie] ; D W Kim [Corée du Sud] ; E. Rubin [États-Unis] ; A. Haregewoin [États-Unis] ; J. Clark [États-Unis] ; P. Watson [États-Unis] ; T. Hughes [Australie] ; I. Dufva [Danemark] ; J L Jimenez [Espagne] ; F-X Mahon [France] ; P. Rousselot [France] ; J. Cortes [États-Unis] ; G. Martinelli [Italie] ; C. Papayannidis [Italie] ; A. Nagler [Israël] ; F J Giles [États-Unis]Source :
- Blood Cancer Journal [ 2044-5385 ] ; 2014.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Chromosome Philadelphie, Femelle, Humains, Inhibiteurs de protéines kinases (administration et posologie), Leucémie myéloïde chronique BCR-ABL positive (génétique), Leucémie myéloïde chronique BCR-ABL positive (traitement médicamenteux), Leucémie-lymphome lymphoblastique à précurseurs B et T (génétique), Leucémie-lymphome lymphoblastique à précurseurs B et T (traitement médicamenteux), Mutation faux-sens, Mâle, Pipérazines (administration et posologie), Protéines de fusion bcr-abl (génétique), Substitution d'acide aminé, Sujet âgé.
- MESH :
- administration et posologie : Inhibiteurs de protéines kinases, Pipérazines.
- génétique : Leucémie myéloïde chronique BCR-ABL positive, Leucémie-lymphome lymphoblastique à précurseurs B et T, Protéines de fusion bcr-abl.
- traitement médicamenteux : Leucémie myéloïde chronique BCR-ABL positive, Leucémie-lymphome lymphoblastique à précurseurs B et T.
- Adulte, Adulte d'âge moyen, Chromosome Philadelphie, Femelle, Humains, Mutation faux-sens, Mâle, Substitution d'acide aminé, Sujet âgé.
English descriptors
- KwdEn :
- Adult, Aged, Amino Acid Substitution, Female, Fusion Proteins, bcr-abl (genetics), Humans, Leukemia, Myelogenous, Chronic, BCR-ABL Positive (drug therapy), Leukemia, Myelogenous, Chronic, BCR-ABL Positive (genetics), Male, Middle Aged, Mutation, Missense, Philadelphia Chromosome, Piperazines (administration & dosage), Precursor Cell Lymphoblastic Leukemia-Lymphoma (drug therapy), Precursor Cell Lymphoblastic Leukemia-Lymphoma (genetics), Protein Kinase Inhibitors (administration & dosage).
- MESH :
- chemical , administration & dosage : Piperazines, Protein Kinase Inhibitors.
- chemical , genetics : Fusion Proteins, bcr-abl.
- drug therapy : Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma.
- genetics : Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma.
- Adult, Aged, Amino Acid Substitution, Female, Humans, Male, Middle Aged, Mutation, Missense, Philadelphia Chromosome.
Abstract
Aurora kinase overexpression has been observed in patients with hematologic malignancies. MK-0457, a pan-aurora kinase inhibitor that also inhibits the ABL T315I mutant, was evaluated to treat patients with chronic myelogenous leukemia (CML) or Philadelphia chromosome (Ph+) acute lymphoblastic leukemia (ALL) with the T315I mutation. Adults with Ph+ chronic phase (CP)-, accelerated phase (AP)- or blast phase (BP)-CML, or ALL and documented BCR-ABL T315I mutation were treated with a 5-day continuous infusion of MK-0457 administered every 14 days at 40 mg/m2/h, 32 mg/m2/h or 24 mg/m2/h. Fifty-two patients (CP,
Url:
DOI: 10.1038/bcj.2014.60
PubMed: 25127392
PubMed Central: 4219463
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PMC:4219463Le document en format XML
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">A phase 2 study of MK-0457 in patients with BCR-ABL T315I mutant chronic myelogenous leukemia and philadelphia chromosome-positive acute lymphoblastic leukemia</title>
<author><name sortKey="Seymour, J F" sort="Seymour, J F" uniqKey="Seymour J" first="J F" last="Seymour">J F Seymour</name>
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<author><name sortKey="Kim, D W" sort="Kim, D W" uniqKey="Kim D" first="D W" last="Kim">D W Kim</name>
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<author><name sortKey="Watson, P" sort="Watson, P" uniqKey="Watson P" first="P" last="Watson">P. Watson</name>
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<author><name sortKey="Hughes, T" sort="Hughes, T" uniqKey="Hughes T" first="T" last="Hughes">T. Hughes</name>
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<author><name sortKey="Dufva, I" sort="Dufva, I" uniqKey="Dufva I" first="I" last="Dufva">I. Dufva</name>
<affiliation wicri:level="1"><nlm:aff id="aff5"><institution>Herlev University Hospital</institution>
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</nlm:aff>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author><name sortKey="Jimenez, J L" sort="Jimenez, J L" uniqKey="Jimenez J" first="J L" last="Jimenez">J L Jimenez</name>
<affiliation wicri:level="1"><nlm:aff id="aff6"><institution>Hospital Universitario Ramon y Cajal</institution>
, Madrid,<country>Spain</country>
</nlm:aff>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author><name sortKey="Mahon, F X" sort="Mahon, F X" uniqKey="Mahon F" first="F-X" last="Mahon">F-X Mahon</name>
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, Bordeaux,<country>France</country>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author><name sortKey="Rousselot, P" sort="Rousselot, P" uniqKey="Rousselot P" first="P" last="Rousselot">P. Rousselot</name>
<affiliation wicri:level="1"><nlm:aff id="aff8"><institution>Hopital de Versailles, Université Versailles Saint Quentin en</institution>
, Yvelines,<country>France</country>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author><name sortKey="Cortes, J" sort="Cortes, J" uniqKey="Cortes J" first="J" last="Cortes">J. Cortes</name>
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</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author><name sortKey="Martinelli, G" sort="Martinelli, G" uniqKey="Martinelli G" first="G" last="Martinelli">G. Martinelli</name>
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</nlm:aff>
<country xml:lang="fr">Italie</country>
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<author><name sortKey="Papayannidis, C" sort="Papayannidis, C" uniqKey="Papayannidis C" first="C" last="Papayannidis">C. Papayannidis</name>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Amino Acid Substitution</term>
<term>Female</term>
<term>Fusion Proteins, bcr-abl (genetics)</term>
<term>Humans</term>
<term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive (drug therapy)</term>
<term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive (genetics)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Mutation, Missense</term>
<term>Philadelphia Chromosome</term>
<term>Piperazines (administration & dosage)</term>
<term>Precursor Cell Lymphoblastic Leukemia-Lymphoma (drug therapy)</term>
<term>Precursor Cell Lymphoblastic Leukemia-Lymphoma (genetics)</term>
<term>Protein Kinase Inhibitors (administration & dosage)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Chromosome Philadelphie</term>
<term>Femelle</term>
<term>Humains</term>
<term>Inhibiteurs de protéines kinases (administration et posologie)</term>
<term>Leucémie myéloïde chronique BCR-ABL positive (génétique)</term>
<term>Leucémie myéloïde chronique BCR-ABL positive (traitement médicamenteux)</term>
<term>Leucémie-lymphome lymphoblastique à précurseurs B et T (génétique)</term>
<term>Leucémie-lymphome lymphoblastique à précurseurs B et T (traitement médicamenteux)</term>
<term>Mutation faux-sens</term>
<term>Mâle</term>
<term>Pipérazines (administration et posologie)</term>
<term>Protéines de fusion bcr-abl (génétique)</term>
<term>Substitution d'acide aminé</term>
<term>Sujet âgé</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Piperazines</term>
<term>Protein Kinase Inhibitors</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="genetics" xml:lang="en"><term>Fusion Proteins, bcr-abl</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Inhibiteurs de protéines kinases</term>
<term>Pipérazines</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</term>
<term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</term>
</keywords>
<keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</term>
<term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</term>
</keywords>
<keywords scheme="MESH" qualifier="génétique" xml:lang="fr"><term>Leucémie myéloïde chronique BCR-ABL positive</term>
<term>Leucémie-lymphome lymphoblastique à précurseurs B et T</term>
<term>Protéines de fusion bcr-abl</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Leucémie myéloïde chronique BCR-ABL positive</term>
<term>Leucémie-lymphome lymphoblastique à précurseurs B et T</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Amino Acid Substitution</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Mutation, Missense</term>
<term>Philadelphia Chromosome</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Chromosome Philadelphie</term>
<term>Femelle</term>
<term>Humains</term>
<term>Mutation faux-sens</term>
<term>Mâle</term>
<term>Substitution d'acide aminé</term>
<term>Sujet âgé</term>
</keywords>
</textClass>
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<front><div type="abstract" xml:lang="en"><p>Aurora kinase overexpression has been observed in patients with hematologic malignancies. MK-0457, a pan-aurora kinase inhibitor that also inhibits the ABL T315I mutant, was evaluated to treat patients with chronic myelogenous leukemia (CML) or Philadelphia chromosome (Ph+) acute lymphoblastic leukemia (ALL) with the T315I mutation. Adults with Ph+ chronic phase (CP)-, accelerated phase (AP)- or blast phase (BP)-CML, or ALL and documented BCR-ABL T315I mutation were treated with a 5-day continuous infusion of MK-0457 administered every 14 days at 40 mg/m<sup>2</sup>
/h, 32 mg/m<sup>2</sup>
/h or 24 mg/m<sup>2</sup>
/h. Fifty-two patients (CP, <italic>n</italic>
=15; AP, <italic>n</italic>
=14; BP, <italic>n</italic>
=11; Ph+ ALL, <italic>n</italic>
=12) were treated. Overall, 8% of patients achieved major cytogenetic response; 6% achieved unconfirmed complete or partial response; 39% had no response. Two patients (CP CML) achieved complete hematologic response. No patients with advanced CML or Ph+ ALL achieved major hematologic response. The most common adverse event (AE) was neutropenia (50%). The most common grade 3/4 AEs were neutropenia (46%) and febrile neutropenia (35%). MK-0457 demonstrated minimal efficacy and only at higher, intolerable doses; lower doses were tolerated and no unexpected toxicities were observed. These data will assist in the development of future aurora kinase inhibitors and in the selection of appropriate target patient populations.</p>
</div>
</front>
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