Azacitidine improves clinical outcomes in older patients with acute myeloid leukaemia with myelodysplasia-related changes compared with conventional care regimens

[Background] Compared with World Health Organization-defined acute myeloid leukaemia (AML) not otherwise specified, patients with AML with myelodysplasia-related changes (AML-MRC) are generally older and more likely to have poor-risk cytogenetics, leading to poor response and prognosis. More than on...

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Autores: Seymour, John F., Döhner, Hartmut, Butrym, Aleksandra, Wierzbowska, Agnieszka, Selleslag, Dominik, Jang, Jun Ho, Kumar, Rajat, Cavenagh, James, Schuh, Andre C., Candoni, Anna, Récher, Christian, Sandhu, Irwindeep, Bernal del Castillo, Teresa, Al-Ali, Haifa Kathrin, Falantes-González, José Francisco, Stone, Richard M., Minden, Mark D., Weaver, Jerry, Songer, Steve, Beach, C. L., Dombret, Hervé
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2017
País:España
Institución:Consejo Superior de Investigaciones Científicas (CSIC)
Repositorio:DIGITAL.CSIC. Repositorio Institucional del CSIC
OAI Identifier:oai:digital.csic.es:10261/180217
Acceso en línea:http://hdl.handle.net/10261/180217
Access Level:acceso abierto
Palabra clave:Azacitidine
Low-dose cytarabine
Acute myeloid leukemia
AML
Myelodysplasia-related changes
AML‐MRC
Induction chemotherapy
Response
Survival
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spelling Azacitidine improves clinical outcomes in older patients with acute myeloid leukaemia with myelodysplasia-related changes compared with conventional care regimensSeymour, John F.Döhner, HartmutButrym, AleksandraWierzbowska, AgnieszkaSelleslag, DominikJang, Jun HoKumar, RajatCavenagh, JamesSchuh, Andre C.Candoni, AnnaRécher, ChristianSandhu, IrwindeepBernal del Castillo, TeresaAl-Ali, Haifa KathrinFalantes-González, José FranciscoStone, Richard M.Minden, Mark D.Weaver, JerrySonger, SteveBeach, C. L.Dombret, HervéAzacitidineLow-dose cytarabineAcute myeloid leukemiaAMLMyelodysplasia-related changesAML‐MRCInduction chemotherapyResponseSurvival[Background] Compared with World Health Organization-defined acute myeloid leukaemia (AML) not otherwise specified, patients with AML with myelodysplasia-related changes (AML-MRC) are generally older and more likely to have poor-risk cytogenetics, leading to poor response and prognosis. More than one-half of all older (≥65 years) patients in the phase 3 AZA-AML-001 trial had newly diagnosed AML-MRC.[Methods] We compared clinical outcomes for patients with AML-MRC treated with azacitidine or conventional care regimens (CCR; induction chemotherapy, low-dose cytarabine, or supportive care only) overall and within patient subgroups defined by cytogenetic risk (intermediate or poor) and age (65–74 years or ≥75 years). The same analyses were used to compare azacitidine with low-dose cytarabine in patients who had been preselected to low-dose cytarabine before they were randomized to receive azacitidine or CCR (ie, low-dose cytarabine).[Results] Median overall survival was significantly prolonged with azacitidine (n = 129) versus CCR (n = 133): 8.9 versus 4.9 months (hazard ratio 0.74, [95%CI 0.57, 0.97]). Among patients with intermediate-risk cytogenetics, median overall survival with azacitidine was 16.4 months, and with CCR was 8.9 months (hazard ratio 0.73 [95%CI 0.48, 1.10]). Median overall survival was significantly improved for patients ages 65–74 years treated with azacitidine compared with those who received CCR (14.2 versus 7.3 months, respectively; hazard ratio 0.64 [95%CI 0.42, 0.97]). Within the subgroup of patients preselected to low-dose cytarabine before randomization, median overall survival with azacitidine was 9.5 months versus 4.6 months with low-dose cytarabine (hazard ratio 0.77 [95%CI 0.55, 1.09]). Within the low-dose cytarabine preselection group, patients with intermediate-risk cytogenetics who received azacitidine had a median overall survival of 14.1 months versus 6.4 months with low-dose cytarabine, and patients aged 65–74 years had median survival of 14.9 months versus 5.2 months, respectively. Overall response rates were similar with azacitidine and CCR (24.8% and 17.3%, respectively), but higher with azacitidine versus low-dose cytarabine (27.2% and 13.9%). Adverse events were generally comparable between the treatment arms.[Conclusions] Azacitidine may be the preferred treatment for patients with AML-MRC who are not candidates for intensive chemotherapy, particularly patients ages 65–74 years and those with intermediate-risk cytogenetics.[Trial registration] This study was registered at clinicalTrials.gov on February 16, 2010 (NCT01074047).This study was funded by Celgene Corporation.Peer reviewedBioMed CentralCelgeneConsejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]201920192017info:eu-repo/semantics/articlehttp://purl.org/coar/resource_type/c_6501Publisher's versioninfo:eu-repo/semantics/publishedVersionhttp://hdl.handle.net/10261/180217reponame:DIGITAL.CSIC. Repositorio Institucional del CSICinstname:Consejo Superior de Investigaciones Científicas (CSIC)Ingléshttps://doi.org/10.1186/s12885-017-3803-6Síinfo:eu-repo/semantics/openAccessoai:digital.csic.es:10261/1802172026-05-22T06:33:51Z
dc.title.none.fl_str_mv Azacitidine improves clinical outcomes in older patients with acute myeloid leukaemia with myelodysplasia-related changes compared with conventional care regimens
title Azacitidine improves clinical outcomes in older patients with acute myeloid leukaemia with myelodysplasia-related changes compared with conventional care regimens
spellingShingle Azacitidine improves clinical outcomes in older patients with acute myeloid leukaemia with myelodysplasia-related changes compared with conventional care regimens
Seymour, John F.
Azacitidine
Low-dose cytarabine
Acute myeloid leukemia
AML
Myelodysplasia-related changes
AML‐MRC
Induction chemotherapy
Response
Survival
title_short Azacitidine improves clinical outcomes in older patients with acute myeloid leukaemia with myelodysplasia-related changes compared with conventional care regimens
title_full Azacitidine improves clinical outcomes in older patients with acute myeloid leukaemia with myelodysplasia-related changes compared with conventional care regimens
title_fullStr Azacitidine improves clinical outcomes in older patients with acute myeloid leukaemia with myelodysplasia-related changes compared with conventional care regimens
title_full_unstemmed Azacitidine improves clinical outcomes in older patients with acute myeloid leukaemia with myelodysplasia-related changes compared with conventional care regimens
title_sort Azacitidine improves clinical outcomes in older patients with acute myeloid leukaemia with myelodysplasia-related changes compared with conventional care regimens
dc.creator.none.fl_str_mv Seymour, John F.
Döhner, Hartmut
Butrym, Aleksandra
Wierzbowska, Agnieszka
Selleslag, Dominik
Jang, Jun Ho
Kumar, Rajat
Cavenagh, James
Schuh, Andre C.
Candoni, Anna
Récher, Christian
Sandhu, Irwindeep
Bernal del Castillo, Teresa
Al-Ali, Haifa Kathrin
Falantes-González, José Francisco
Stone, Richard M.
Minden, Mark D.
Weaver, Jerry
Songer, Steve
Beach, C. L.
Dombret, Hervé
author Seymour, John F.
author_facet Seymour, John F.
Döhner, Hartmut
Butrym, Aleksandra
Wierzbowska, Agnieszka
Selleslag, Dominik
Jang, Jun Ho
Kumar, Rajat
Cavenagh, James
Schuh, Andre C.
Candoni, Anna
Récher, Christian
Sandhu, Irwindeep
Bernal del Castillo, Teresa
Al-Ali, Haifa Kathrin
Falantes-González, José Francisco
Stone, Richard M.
Minden, Mark D.
Weaver, Jerry
Songer, Steve
Beach, C. L.
Dombret, Hervé
author_role author
author2 Döhner, Hartmut
Butrym, Aleksandra
Wierzbowska, Agnieszka
Selleslag, Dominik
Jang, Jun Ho
Kumar, Rajat
Cavenagh, James
Schuh, Andre C.
Candoni, Anna
Récher, Christian
Sandhu, Irwindeep
Bernal del Castillo, Teresa
Al-Ali, Haifa Kathrin
Falantes-González, José Francisco
Stone, Richard M.
Minden, Mark D.
Weaver, Jerry
Songer, Steve
Beach, C. L.
Dombret, Hervé
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Celgene
Consejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]
dc.subject.none.fl_str_mv Azacitidine
Low-dose cytarabine
Acute myeloid leukemia
AML
Myelodysplasia-related changes
AML‐MRC
Induction chemotherapy
Response
Survival
topic Azacitidine
Low-dose cytarabine
Acute myeloid leukemia
AML
Myelodysplasia-related changes
AML‐MRC
Induction chemotherapy
Response
Survival
description [Background] Compared with World Health Organization-defined acute myeloid leukaemia (AML) not otherwise specified, patients with AML with myelodysplasia-related changes (AML-MRC) are generally older and more likely to have poor-risk cytogenetics, leading to poor response and prognosis. More than one-half of all older (≥65 years) patients in the phase 3 AZA-AML-001 trial had newly diagnosed AML-MRC.
publishDate 2017
dc.date.none.fl_str_mv 2017
2019
2019
dc.type.none.fl_str_mv info:eu-repo/semantics/article
http://purl.org/coar/resource_type/c_6501
Publisher's version
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10261/180217
url http://hdl.handle.net/10261/180217
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv https://doi.org/10.1186/s12885-017-3803-6
Sí
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv BioMed Central
publisher.none.fl_str_mv BioMed Central
dc.source.none.fl_str_mv reponame:DIGITAL.CSIC. Repositorio Institucional del CSIC
instname:Consejo Superior de Investigaciones Científicas (CSIC)
instname_str Consejo Superior de Investigaciones Científicas (CSIC)
reponame_str DIGITAL.CSIC. Repositorio Institucional del CSIC
collection DIGITAL.CSIC. Repositorio Institucional del CSIC
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15.812429

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