Evaluation of cardiovascular ischemic event rates in dasatinib-treated patients using standardized incidence ratios.
Identifieur interne : 000C75 ( PubMed/Checkpoint ); précédent : 000C74; suivant : 000C76Evaluation 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 [ 1432-0584 ] ; 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.
DOI: 10.1007/s00277-017-3012-z
PubMed: 28534184
Affiliations:
- Allemagne, Australie, France, Italie, République tchèque, États-Unis
- Aquitaine, Berlin, Californie, Moravie, New Jersey, Nouvelle-Aquitaine, Texas
- Berlin, Bordeaux, Brno
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pubmed:28534184Le document en format XML
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<front><div type="abstract" xml:lang="en">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.</div>
</front>
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<Abstract><AbstractText>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.</AbstractText>
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<ForeName>Giuseppe</ForeName>
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<AffiliationInfo><Affiliation>Clinical and Biological Sciences of the University of Turin, San Luigi Hospital, 10043, Orbassano-Torino, Italy. giuseppe.saglio@unito.it.</Affiliation>
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<ForeName>Philipp</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Charité, Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin, Germany.</Affiliation>
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</Author>
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<ForeName>Jorge</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>The University of Texas MD Anderson Cancer Center, Houston, TX, USA.</Affiliation>
</AffiliationInfo>
</Author>
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<ForeName>Jiří</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Department of Internal Medicine, Hematology and Oncology, Masaryk University Hospital Brno, Brno, Czech Republic.</Affiliation>
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<ForeName>Philip</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Calvary Mater Newcastle Hospital, University of Newcastle, Waratah, NSW, Australia.</Affiliation>
</AffiliationInfo>
</Author>
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<Initials>FX</Initials>
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</Author>
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<ForeName>Glenn</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>Bristol-Myers Squibb, Princeton, NJ, USA.</Affiliation>
</AffiliationInfo>
</Author>
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<ForeName>Kyna</ForeName>
<Initials>K</Initials>
<AffiliationInfo><Affiliation>Bristol-Myers Squibb, Princeton, NJ, USA.</Affiliation>
</AffiliationInfo>
</Author>
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<ForeName>Milayna</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Bristol-Myers Squibb, Princeton, NJ, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Shah</LastName>
<ForeName>Neil P</ForeName>
<Initials>NP</Initials>
<AffiliationInfo><Affiliation>UCSF School of Medicine, San Francisco, CA, USA.</Affiliation>
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<Language>eng</Language>
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<Month>05</Month>
<Day>22</Day>
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</MeshHeading>
<MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000971" MajorTopicYN="N">Antineoplastic Combined Chemotherapy Protocols</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName>
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<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
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<MeshHeading><DescriptorName UI="D015994" MajorTopicYN="N">Incidence</DescriptorName>
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<QualifierName UI="Q000139" MajorTopicYN="Y">chemically induced</QualifierName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
</MeshHeading>
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<MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
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</MeshHeading>
<MeshHeading><DescriptorName UI="D017063" MajorTopicYN="N">Outcome Assessment (Health Care)</DescriptorName>
<QualifierName UI="Q000379" MajorTopicYN="N">methods</QualifierName>
<QualifierName UI="Q000706" MajorTopicYN="Y">statistics & numerical data</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D011471" MajorTopicYN="N">Prostatic Neoplasms</DescriptorName>
<QualifierName UI="Q000188" MajorTopicYN="N">drug therapy</QualifierName>
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<MeshHeading><DescriptorName UI="D047428" MajorTopicYN="N">Protein Kinase Inhibitors</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
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<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Cardiovascular</Keyword>
<Keyword MajorTopicYN="N">Chronic myeloid leukemia</Keyword>
<Keyword MajorTopicYN="N">Dasatinib</Keyword>
<Keyword MajorTopicYN="N">Ischemic</Keyword>
<Keyword MajorTopicYN="N">Tyrosine kinase inhibitors</Keyword>
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<ArticleId IdType="doi">10.1007/s00277-017-3012-z</ArticleId>
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<li>États-Unis</li>
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<region><li>Aquitaine</li>
<li>Berlin</li>
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<li>Moravie</li>
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<country name="France"><region name="Nouvelle-Aquitaine"><name sortKey="Mahon, Francois Xavier" sort="Mahon, Francois Xavier" uniqKey="Mahon F" first="François-Xavier" last="Mahon">François-Xavier Mahon</name>
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