Evaluation of cardiovascular ischemic event rates in dasatinib-treated patients using standardized incidence ratios
Identifieur interne : 000C71 ( Main/Exploration ); précédent : 000C70; suivant : 000C72Evaluation of cardiovascular ischemic event rates in dasatinib-treated patients using standardized incidence ratios
Auteurs : Giuseppe Saglio [Italie] ; Philipp Le Coutre [Allemagne] ; Jorge Cortes [États-Unis] ; Ji Mayer [République tchèque] ; Philip Rowlings [Australie] ; François-Xavier Mahon [France] ; Glenn Kroog [États-Unis] ; Kyna Gooden [États-Unis] ; Milayna Subar [États-Unis] ; Neil P. Shah [États-Unis]Source :
- Annals of Hematology [ 0939-5555 ] ; 2017.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Dasatinib (effets indésirables), Essais cliniques comme sujet (), Femelle, Humains, Incidence, Inhibiteurs de protéines kinases (effets indésirables), Ischémie (), Ischémie (épidémiologie), Leucémie myéloïde chronique BCR-ABL positive (traitement médicamenteux), Maladies cardiovasculaires (), Maladies cardiovasculaires (épidémiologie), Mâle, Protocoles de polychimiothérapie antinéoplasique (effets indésirables), Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique), Sujet âgé, Tumeurs de la prostate (traitement médicamenteux), Évaluation de résultat (soins) ().
- MESH :
- effets indésirables : Dasatinib, Inhibiteurs de protéines kinases, Protocoles de polychimiothérapie antinéoplasique.
- traitement médicamenteux : Leucémie myéloïde chronique BCR-ABL positive, Tumeurs de la prostate.
- usage thérapeutique : Protocoles de polychimiothérapie antinéoplasique.
- épidémiologie : Ischémie, Maladies cardiovasculaires.
- Adulte, Adulte d'âge moyen, Essais cliniques comme sujet, Femelle, Humains, Incidence, Ischémie, Maladies cardiovasculaires, Mâle, Sujet âgé, Évaluation de résultat (soins).
English descriptors
- KwdEn :
- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols (adverse effects), Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Cardiovascular Diseases (chemically induced), Cardiovascular Diseases (epidemiology), Clinical Trials as Topic (methods), Clinical Trials as Topic (statistics & numerical data), Dasatinib (adverse effects), Female, Humans, Incidence, Ischemia (chemically induced), Ischemia (epidemiology), Leukemia, Myelogenous, Chronic, BCR-ABL Positive (drug therapy), Male, Middle Aged, Outcome Assessment (Health Care) (methods), Outcome Assessment (Health Care) (statistics & numerical data), Prostatic Neoplasms (drug therapy), Protein Kinase Inhibitors (adverse effects).
- MESH :
- chemical , adverse effects : Dasatinib, Protein Kinase Inhibitors.
- adverse effects : Antineoplastic Combined Chemotherapy Protocols.
- chemically induced : Cardiovascular Diseases, Ischemia.
- drug therapy : Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Prostatic Neoplasms.
- epidemiology : Cardiovascular Diseases, Ischemia.
- methods : Clinical Trials as Topic, Outcome Assessment (Health Care).
- statistics & numerical data : Clinical Trials as Topic, Outcome Assessment (Health Care).
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols.
- Adult, Aged, Female, Humans, Incidence, Male, Middle Aged.
Abstract
With high survival rates for chronic myeloid leukemia (CML) patients treated with BCR-ABL1 tyrosine kinase inhibitors (TKIs), emerging consequences, such as arterial ischemic events, require consideration when evaluating treatment options. Cardiovascular ischemic event incidence in clinical trials was evaluated in 2712 dasatinib-treated patients with Philadelphia chromosome-positive (Ph+) leukemias from 11 first- and second-line trials (pooled), newly diagnosed CML patients treated with dasatinib or imatinib (DASISION), and prostate cancer patients treated with dasatinib or placebo plus docetaxel/prednisone (READY). Overall, 2–4% of dasatinib-treated patients had cardiovascular ischemic events. Most dasatinib-treated patients with an event had a history of and/or risk factor for atherosclerosis (pooled 77 with history/risk and event/96 with events; DASISION 8/10; READY 15/18). Most cardiovascular ischemic events occurred within 1 year of initiating dasatinib (pooled 69/96; DASISION 7/10; READY 16/18). Comparison of observed and expected event rates through standardized incidence ratios indicates that dasatinib does not increase risk for cardiovascular ischemic events compared with external reference populations.
The online version of this article (doi:10.1007/s00277-017-3012-z) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1007/s00277-017-3012-z
PubMed: 28534184
PubMed Central: 5486782
Affiliations:
- Allemagne, Australie, France, Italie, République tchèque, États-Unis
- Californie, New Jersey, Nouvelle-Galles du Sud, Texas
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Le document en format XML
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institution-id-type="GRID">grid.419971.3</institution-id><institution></institution><institution>Bristol-Myers Squibb,</institution></institution-wrap>Princeton, NJ USA</nlm:aff><country>États-Unis</country><placeName><region type="state">New Jersey</region></placeName><wicri:cityArea>Princeton</wicri:cityArea></affiliation></author><author><name sortKey="Subar, Milayna" sort="Subar, Milayna" uniqKey="Subar M" first="Milayna" last="Subar">Milayna Subar</name><affiliation wicri:level="2"><nlm:aff id="Aff7"><institution-wrap><institution-id institution-id-type="GRID">grid.419971.3</institution-id><institution></institution><institution>Bristol-Myers Squibb,</institution></institution-wrap>Princeton, NJ USA</nlm:aff><country>États-Unis</country><placeName><region type="state">New Jersey</region></placeName><wicri:cityArea>Princeton</wicri:cityArea></affiliation></author><author><name sortKey="Shah, Neil P" sort="Shah, Neil P" uniqKey="Shah N" first="Neil P." last="Shah">Neil P. Shah</name><affiliation wicri:level="2"><nlm:aff id="Aff8"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2297 6811</institution-id><institution-id institution-id-type="GRID">grid.266102.1</institution-id><institution></institution><institution>UCSF School of Medicine,</institution></institution-wrap>San Francisco, CA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>San Francisco</wicri:cityArea></affiliation></author></analytic><series><title level="j">Annals of Hematology</title><idno type="ISSN">0939-5555</idno><idno type="eISSN">1432-0584</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Antineoplastic Combined Chemotherapy Protocols (adverse effects)</term><term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term><term>Cardiovascular Diseases (chemically induced)</term><term>Cardiovascular Diseases (epidemiology)</term><term>Clinical Trials as Topic (methods)</term><term>Clinical Trials as Topic (statistics & numerical data)</term><term>Dasatinib (adverse effects)</term><term>Female</term><term>Humans</term><term>Incidence</term><term>Ischemia (chemically induced)</term><term>Ischemia (epidemiology)</term><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive (drug therapy)</term><term>Male</term><term>Middle Aged</term><term>Outcome Assessment (Health Care) (methods)</term><term>Outcome Assessment (Health Care) (statistics & numerical data)</term><term>Prostatic Neoplasms (drug therapy)</term><term>Protein Kinase Inhibitors (adverse effects)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Dasatinib (effets indésirables)</term><term>Essais cliniques comme sujet ()</term><term>Femelle</term><term>Humains</term><term>Incidence</term><term>Inhibiteurs de protéines kinases (effets indésirables)</term><term>Ischémie ()</term><term>Ischémie (épidémiologie)</term><term>Leucémie myéloïde chronique BCR-ABL positive (traitement médicamenteux)</term><term>Maladies cardiovasculaires ()</term><term>Maladies cardiovasculaires (épidémiologie)</term><term>Mâle</term><term>Protocoles de polychimiothérapie antinéoplasique (effets indésirables)</term><term>Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique)</term><term>Sujet âgé</term><term>Tumeurs de la prostate (traitement médicamenteux)</term><term>Évaluation de résultat (soins) ()</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Dasatinib</term><term>Protein Kinase Inhibitors</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Cardiovascular Diseases</term><term>Ischemia</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</term><term>Prostatic Neoplasms</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Dasatinib</term><term>Inhibiteurs de protéines kinases</term><term>Protocoles de polychimiothérapie antinéoplasique</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Cardiovascular Diseases</term><term>Ischemia</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Clinical Trials as Topic</term><term>Outcome Assessment (Health Care)</term></keywords><keywords scheme="MESH" qualifier="statistics & numerical data" xml:lang="en"><term>Clinical Trials as Topic</term><term>Outcome Assessment (Health Care)</term></keywords><keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Leucémie myéloïde chronique BCR-ABL positive</term><term>Tumeurs de la prostate</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Protocoles de polychimiothérapie antinéoplasique</term></keywords><keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Ischémie</term><term>Maladies cardiovasculaires</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Female</term><term>Humans</term><term>Incidence</term><term>Male</term><term>Middle Aged</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Essais cliniques comme sujet</term><term>Femelle</term><term>Humains</term><term>Incidence</term><term>Ischémie</term><term>Maladies cardiovasculaires</term><term>Mâle</term><term>Sujet âgé</term><term>Évaluation de résultat (soins)</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p id="Par1">With high survival rates for chronic myeloid leukemia (CML) patients treated with BCR-ABL1 tyrosine kinase inhibitors (TKIs), emerging consequences, such as arterial ischemic events, require consideration when evaluating treatment options. Cardiovascular ischemic event incidence in clinical trials was evaluated in 2712 dasatinib-treated patients with Philadelphia chromosome-positive (Ph+) leukemias from 11 first- and second-line trials (pooled), newly diagnosed CML patients treated with dasatinib or imatinib (DASISION), and prostate cancer patients treated with dasatinib or placebo plus docetaxel/prednisone (READY). Overall, 2–4% of dasatinib-treated patients had cardiovascular ischemic events. Most dasatinib-treated patients with an event had a history of and/or risk factor for atherosclerosis (pooled 77 with history/risk and event/96 with events; DASISION 8/10; READY 15/18). Most cardiovascular ischemic events occurred within 1 year of initiating dasatinib (pooled 69/96; DASISION 7/10; READY 16/18). Comparison of observed and expected event rates through standardized incidence ratios indicates that dasatinib does not increase risk for cardiovascular ischemic events compared with external reference populations.</p><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1007/s00277-017-3012-z) contains supplementary material, which is available to authorized users.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Baccarani, M" uniqKey="Baccarani M">M Baccarani</name></author><author><name sortKey="Efficace, F" uniqKey="Efficace F">F Efficace</name></author><author><name sortKey="Rosti, G" uniqKey="Rosti G">G Rosti</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Valent, P" uniqKey="Valent P">P 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sortKey="Moy, Cs" uniqKey="Moy C">CS Moy</name></author><author><name sortKey="Muntner, P" uniqKey="Muntner P">P Muntner</name></author><author><name sortKey="Mussolino, Me" uniqKey="Mussolino M">ME Mussolino</name></author><author><name sortKey="Nasir, K" uniqKey="Nasir K">K Nasir</name></author><author><name sortKey="Neumar, Rw" uniqKey="Neumar R">RW Neumar</name></author><author><name sortKey="Nichol, G" uniqKey="Nichol G">G Nichol</name></author><author><name sortKey="Palaniappan, L" uniqKey="Palaniappan L">L Palaniappan</name></author><author><name sortKey="Pandey, Dk" uniqKey="Pandey D">DK Pandey</name></author><author><name sortKey="Reeves, Mj" uniqKey="Reeves M">MJ Reeves</name></author><author><name sortKey="Rodriguez, Cj" uniqKey="Rodriguez C">CJ Rodriguez</name></author><author><name sortKey="Sorlie, Pd" uniqKey="Sorlie P">PD Sorlie</name></author><author><name sortKey="Stein, J" uniqKey="Stein J">J Stein</name></author><author><name sortKey="Towfighi, A" uniqKey="Towfighi 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Hansen</name></author><author><name sortKey="Subar, M" uniqKey="Subar M">M Subar</name></author><author><name sortKey="Turner, M" uniqKey="Turner M">M Turner</name></author><author><name sortKey="Zyczynski, T" uniqKey="Zyczynski T">T Zyczynski</name></author><author><name sortKey="Mohamed, H" uniqKey="Mohamed H">H Mohamed</name></author><author><name sortKey="Goldberg, Sl" uniqKey="Goldberg S">SL Goldberg</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Conteduca, V" uniqKey="Conteduca V">V Conteduca</name></author><author><name sortKey="Di Lorenzo, G" uniqKey="Di Lorenzo G">G Di Lorenzo</name></author><author><name sortKey="Tartarone, A" uniqKey="Tartarone A">A Tartarone</name></author><author><name sortKey="Aieta, M" uniqKey="Aieta M">M Aieta</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>France</li><li>Italie</li><li>République tchèque</li><li>États-Unis</li></country><region><li>Californie</li><li>New Jersey</li><li>Nouvelle-Galles du Sud</li><li>Texas</li></region></list><tree><country name="Italie"><noRegion><name sortKey="Saglio, Giuseppe" sort="Saglio, Giuseppe" uniqKey="Saglio G" first="Giuseppe" last="Saglio">Giuseppe Saglio</name></noRegion></country><country name="Allemagne"><noRegion><name sortKey="Le Coutre, Philipp" sort="Le Coutre, Philipp" uniqKey="Le Coutre P" first="Philipp" last="Le Coutre">Philipp Le Coutre</name></noRegion></country><country name="États-Unis"><region name="Texas"><name sortKey="Cortes, Jorge" sort="Cortes, Jorge" uniqKey="Cortes J" first="Jorge" last="Cortes">Jorge Cortes</name></region><name sortKey="Gooden, Kyna" sort="Gooden, Kyna" uniqKey="Gooden K" first="Kyna" last="Gooden">Kyna Gooden</name><name sortKey="Kroog, Glenn" sort="Kroog, Glenn" uniqKey="Kroog G" first="Glenn" last="Kroog">Glenn Kroog</name><name sortKey="Shah, Neil P" sort="Shah, Neil P" uniqKey="Shah N" first="Neil P." last="Shah">Neil P. Shah</name><name sortKey="Subar, Milayna" sort="Subar, Milayna" uniqKey="Subar M" first="Milayna" last="Subar">Milayna Subar</name></country><country name="République tchèque"><noRegion><name sortKey="Mayer, Ji" sort="Mayer, Ji" uniqKey="Mayer J" first="Ji" last="Mayer">Ji Mayer</name></noRegion></country><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Rowlings, Philip" sort="Rowlings, Philip" uniqKey="Rowlings P" first="Philip" last="Rowlings">Philip Rowlings</name></region></country><country name="France"><noRegion><name sortKey="Mahon, Francois Xavier" sort="Mahon, Francois Xavier" uniqKey="Mahon F" first="François-Xavier" last="Mahon">François-Xavier Mahon</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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