Incidence rates of treatment-emergent adverse events and related hospitalization are reduced with azacitidine compared with conventional care regimens in older patients with acute myeloid leukemia.
Identifieur interne : 000A00 ( PubMed/Checkpoint ); précédent : 000999; suivant : 000A01Incidence rates of treatment-emergent adverse events and related hospitalization are reduced with azacitidine compared with conventional care regimens in older patients with acute myeloid leukemia.
Auteurs : John F. Seymour [Australie] ; Hartmut Döhner [Allemagne] ; Mark D. Minden [Canada] ; Richard Stone [États-Unis] ; Dominique Gambini [États-Unis] ; Donna Dougherty [États-Unis] ; C L Beach [États-Unis] ; Jerry Weaver [États-Unis] ; Hervé Dombret [France]Source :
- Leukemia & lymphoma [ 1029-2403 ] ; 2017.
Abstract
Relative risks of treatment-emergent adverse events (TEAEs) and related hospitalization is most accurate when accounting for treatment exposure. AZA-AML-001 showed azacitidine (AZA) prolonged overall survival versus conventional care regimens (CCR) in older patients (≥65 years) with acute myeloid leukemia (AML) by 3.9 months. Preselection of CCR before study randomization allows evaluation of AZA safety in patient subgroups with similar clinical features. Within preselection groups, AZA exposure was greater than each CCR. Incidence rates (IRs; numbers of events normalized for drug exposure time) of hospitalizations and days in hospital for TEAEs per patient-year of exposure were to varying degrees lower with AZA versus each CCR. Overall survival was significantly prolonged with AZA versus best supportive care (BSC) in AZA-AML-001; this analysis showed 55% and 41% reductions in IRs of TEAE-related hospitalization and days in hospital, respectively, with AZA versus BSC. Older patients with AML unable to tolerate intensive therapy should be offered active low-intensity treatment.
DOI: 10.1080/10428194.2016.1243680
PubMed: 27739920
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Seymour</name><affiliation wicri:level="1"><nlm:affiliation>a Peter MacCallum Cancer Center, University of Melbourne , Parkville , Melbourne , Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>a Peter MacCallum Cancer Center, University of Melbourne , Parkville , Melbourne </wicri:regionArea><wicri:noRegion>Melbourne </wicri:noRegion></affiliation></author><author><name sortKey="Dohner, Hartmut" sort="Dohner, Hartmut" uniqKey="Dohner H" first="Hartmut" last="Döhner">Hartmut Döhner</name><affiliation wicri:level="1"><nlm:affiliation>b Universitätsklinikum Ulm , Ulm , Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>b Universitätsklinikum Ulm , Ulm </wicri:regionArea><wicri:noRegion>Ulm </wicri:noRegion><wicri:noRegion>Ulm </wicri:noRegion><wicri:noRegion>Ulm </wicri:noRegion></affiliation></author><author><name sortKey="Minden, Mark D" sort="Minden, Mark D" uniqKey="Minden M" first="Mark D" last="Minden">Mark D. 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Seymour</name><affiliation wicri:level="1"><nlm:affiliation>a Peter MacCallum Cancer Center, University of Melbourne , Parkville , Melbourne , Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>a Peter MacCallum Cancer Center, University of Melbourne , Parkville , Melbourne </wicri:regionArea><wicri:noRegion>Melbourne </wicri:noRegion></affiliation></author><author><name sortKey="Dohner, Hartmut" sort="Dohner, Hartmut" uniqKey="Dohner H" first="Hartmut" last="Döhner">Hartmut Döhner</name><affiliation wicri:level="1"><nlm:affiliation>b Universitätsklinikum Ulm , Ulm , Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>b Universitätsklinikum Ulm , Ulm </wicri:regionArea><wicri:noRegion>Ulm </wicri:noRegion><wicri:noRegion>Ulm </wicri:noRegion><wicri:noRegion>Ulm </wicri:noRegion></affiliation></author><author><name sortKey="Minden, Mark D" sort="Minden, Mark D" uniqKey="Minden M" first="Mark D" last="Minden">Mark D. Minden</name><affiliation wicri:level="1"><nlm:affiliation>c Princess Margaret Hospital , Toronto , Ontario , Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>c Princess Margaret Hospital , Toronto , Ontario </wicri:regionArea><wicri:noRegion>Ontario </wicri:noRegion></affiliation></author><author><name sortKey="Stone, Richard" sort="Stone, Richard" uniqKey="Stone R" first="Richard" last="Stone">Richard Stone</name><affiliation wicri:level="2"><nlm:affiliation>d Dana-Farber Cancer Institute , Boston , MA , USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>d Dana-Farber Cancer Institute , Boston , MA </wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Gambini, Dominique" sort="Gambini, Dominique" uniqKey="Gambini D" first="Dominique" last="Gambini">Dominique Gambini</name><affiliation wicri:level="2"><nlm:affiliation>e Celgene Corporation , Summit , NJ , USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>e Celgene Corporation , Summit , NJ </wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Dougherty, Donna" sort="Dougherty, Donna" uniqKey="Dougherty D" first="Donna" last="Dougherty">Donna Dougherty</name><affiliation wicri:level="2"><nlm:affiliation>e Celgene Corporation , Summit , NJ , USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>e Celgene Corporation , Summit , NJ </wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Beach, C L" sort="Beach, C L" uniqKey="Beach C" first="C L" last="Beach">C L Beach</name><affiliation wicri:level="2"><nlm:affiliation>e Celgene Corporation , Summit , NJ , USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>e Celgene Corporation , Summit , NJ </wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Weaver, Jerry" sort="Weaver, Jerry" uniqKey="Weaver J" first="Jerry" last="Weaver">Jerry Weaver</name><affiliation wicri:level="2"><nlm:affiliation>e Celgene Corporation , Summit , NJ , USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>e Celgene Corporation , Summit , NJ </wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Dombret, Herve" sort="Dombret, Herve" uniqKey="Dombret H" first="Hervé" last="Dombret">Hervé Dombret</name><affiliation wicri:level="1"><nlm:affiliation>f Hôpital Saint Louis, Institut Universitaire d'Hématologie , Paris , France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>f Hôpital Saint Louis, Institut Universitaire d'Hématologie , Paris </wicri:regionArea><wicri:noRegion>Paris </wicri:noRegion><wicri:noRegion>Paris </wicri:noRegion></affiliation></author></analytic><series><title level="j">Leukemia & lymphoma</title><idno type="eISSN">1029-2403</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Relative risks of treatment-emergent adverse events (TEAEs) and related hospitalization is most accurate when accounting for treatment exposure. AZA-AML-001 showed azacitidine (AZA) prolonged overall survival versus conventional care regimens (CCR) in older patients (≥65 years) with acute myeloid leukemia (AML) by 3.9 months. Preselection of CCR before study randomization allows evaluation of AZA safety in patient subgroups with similar clinical features. Within preselection groups, AZA exposure was greater than each CCR. Incidence rates (IRs; numbers of events normalized for drug exposure time) of hospitalizations and days in hospital for TEAEs per patient-year of exposure were to varying degrees lower with AZA versus each CCR. Overall survival was significantly prolonged with AZA versus best supportive care (BSC) in AZA-AML-001; this analysis showed 55% and 41% reductions in IRs of TEAE-related hospitalization and days in hospital, respectively, with AZA versus BSC. Older patients with AML unable to tolerate intensive therapy should be offered active low-intensity treatment.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">27739920</PMID><DateCreated><Year>2016</Year><Month>10</Month><Day>14</Day></DateCreated><DateRevised><Year>2017</Year><Month>03</Month><Day>08</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1029-2403</ISSN><JournalIssue CitedMedium="Internet"><Volume>58</Volume><Issue>6</Issue><PubDate><Year>2017</Year><Month>Jun</Month></PubDate></JournalIssue><Title>Leukemia & lymphoma</Title><ISOAbbreviation>Leuk. Lymphoma</ISOAbbreviation></Journal><ArticleTitle>Incidence rates of treatment-emergent adverse events and related hospitalization are reduced with azacitidine compared with conventional care regimens in older patients with acute myeloid leukemia.</ArticleTitle><Pagination><MedlinePgn>1412-1423</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1080/10428194.2016.1243680</ELocationID><Abstract><AbstractText>Relative risks of treatment-emergent adverse events (TEAEs) and related hospitalization is most accurate when accounting for treatment exposure. AZA-AML-001 showed azacitidine (AZA) prolonged overall survival versus conventional care regimens (CCR) in older patients (≥65 years) with acute myeloid leukemia (AML) by 3.9 months. Preselection of CCR before study randomization allows evaluation of AZA safety in patient subgroups with similar clinical features. Within preselection groups, AZA exposure was greater than each CCR. Incidence rates (IRs; numbers of events normalized for drug exposure time) of hospitalizations and days in hospital for TEAEs per patient-year of exposure were to varying degrees lower with AZA versus each CCR. Overall survival was significantly prolonged with AZA versus best supportive care (BSC) in AZA-AML-001; this analysis showed 55% and 41% reductions in IRs of TEAE-related hospitalization and days in hospital, respectively, with AZA versus BSC. Older patients with AML unable to tolerate intensive therapy should be offered active low-intensity treatment.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Seymour</LastName><ForeName>John F</ForeName><Initials>JF</Initials><AffiliationInfo><Affiliation>a Peter MacCallum Cancer Center, University of Melbourne , Parkville , Melbourne , Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Döhner</LastName><ForeName>Hartmut</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>b Universitätsklinikum Ulm , Ulm , Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Minden</LastName><ForeName>Mark D</ForeName><Initials>MD</Initials><AffiliationInfo><Affiliation>c Princess Margaret Hospital , Toronto , Ontario , Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stone</LastName><ForeName>Richard</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>d Dana-Farber Cancer Institute , Boston , MA , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gambini</LastName><ForeName>Dominique</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>e Celgene Corporation , Summit , NJ , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dougherty</LastName><ForeName>Donna</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>e Celgene Corporation , Summit , NJ , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Beach</LastName><ForeName>C L</ForeName><Initials>CL</Initials><AffiliationInfo><Affiliation>e Celgene Corporation , Summit , NJ , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Weaver</LastName><ForeName>Jerry</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>e Celgene Corporation , Summit , NJ , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dombret</LastName><ForeName>Hervé</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>f Hôpital Saint Louis, Institut Universitaire d'Hématologie , Paris , France.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>10</Month><Day>14</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Leuk Lymphoma</MedlineTA><NlmUniqueID>9007422</NlmUniqueID><ISSNLinking>1026-8022</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">AE</Keyword><Keyword MajorTopicYN="N">Azacitidine</Keyword><Keyword MajorTopicYN="N">TEAE</Keyword><Keyword MajorTopicYN="N">hospitalization</Keyword><Keyword MajorTopicYN="N">treatment-emergent adverse event</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>10</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>10</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>10</Month><Day>15</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">27739920</ArticleId><ArticleId IdType="doi">10.1080/10428194.2016.1243680</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Canada</li><li>France</li><li>États-Unis</li></country><region><li>Massachusetts</li><li>New Jersey</li></region></list><tree><country name="Australie"><noRegion><name sortKey="Seymour, John F" sort="Seymour, John F" uniqKey="Seymour J" first="John F" last="Seymour">John F. Seymour</name></noRegion></country><country name="Allemagne"><noRegion><name sortKey="Dohner, Hartmut" sort="Dohner, Hartmut" uniqKey="Dohner H" first="Hartmut" last="Döhner">Hartmut Döhner</name></noRegion></country><country name="Canada"><noRegion><name sortKey="Minden, Mark D" sort="Minden, Mark D" uniqKey="Minden M" first="Mark D" last="Minden">Mark D. Minden</name></noRegion></country><country name="États-Unis"><region name="Massachusetts"><name sortKey="Stone, Richard" sort="Stone, Richard" uniqKey="Stone R" first="Richard" last="Stone">Richard Stone</name></region><name sortKey="Beach, C L" sort="Beach, C L" uniqKey="Beach C" first="C L" last="Beach">C L Beach</name><name sortKey="Dougherty, Donna" sort="Dougherty, Donna" uniqKey="Dougherty D" first="Donna" last="Dougherty">Donna Dougherty</name><name sortKey="Gambini, Dominique" sort="Gambini, Dominique" uniqKey="Gambini D" first="Dominique" last="Gambini">Dominique Gambini</name><name sortKey="Weaver, Jerry" sort="Weaver, Jerry" uniqKey="Weaver J" first="Jerry" last="Weaver">Jerry Weaver</name></country><country name="France"><noRegion><name sortKey="Dombret, Herve" sort="Dombret, Herve" uniqKey="Dombret H" first="Hervé" last="Dombret">Hervé Dombret</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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