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Oral Azacitidine Maintenance Therapy for Acute Myeloid Leukemia in First Remission

2020-12Journal article Open access
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dc.contributor.authorWei, A
dc.contributor.authorDöhner, H
dc.contributor.authorPocock, C
dc.contributor.authorMontesinos, P
dc.contributor.authorAfanasyev, B
dc.contributor.authorDombret, H
dc.contributor.authorRavandi, F
dc.contributor.authorSayar, H
dc.contributor.authorJang, JH
dc.contributor.authorPorkka, K
dc.contributor.authorSelleslag, D
dc.contributor.authorSandhu, I
dc.contributor.authorTurgut, M
dc.contributor.authorGiai, V
dc.contributor.authorOfran, Y
dc.contributor.authorKizil Çakar, M
dc.contributor.authorBotelho de Sousa, A
dc.contributor.authorRybka, J
dc.contributor.authorFrairia, C
dc.contributor.authorBorin, L
dc.contributor.authorBeltrami, G
dc.contributor.authorČermák, J
dc.contributor.authorOssenkoppele, G
dc.contributor.authorLa Torre, I
dc.contributor.authorSkikne, B
dc.contributor.authorKumar, K
dc.contributor.authorDong, Q
dc.contributor.authorBeach, C
dc.contributor.authorRoboz, G
dc.date.accessioned2023-10-06T14:32:10Z
dc.date.available2023-10-06T14:32:10Z
dc.date.issued2020-12
dc.description.abstractBackground: Although induction chemotherapy results in remission in many older patients with acute myeloid leukemia (AML), relapse is common and overall survival is poor. Methods: We conducted a phase 3, randomized, double-blind, placebo-controlled trial of the oral formulation of azacitidine (CC-486, a hypomethylating agent that is not bioequivalent to injectable azacitidine), as maintenance therapy in patients with AML who were in first remission after intensive chemotherapy. Patients who were 55 years of age or older, were in complete remission with or without complete blood count recovery, and were not candidates for hematopoietic stem-cell transplantation were randomly assigned to receive CC-486 (300 mg) or placebo once daily for 14 days per 28-day cycle. The primary end point was overall survival. Secondary end points included relapse-free survival and health-related quality of life. Results: A total of 472 patients underwent randomization; 238 were assigned to the CC-486 group and 234 were assigned to the placebo group. The median age was 68 years (range, 55 to 86). Median overall survival from the time of randomization was significantly longer with CC-486 than with placebo (24.7 months and 14.8 months, respectively; P<0.001). Median relapse-free survival was also significantly longer with CC-486 than with placebo (10.2 months and 4.8 months, respectively; P<0.001). Benefits of CC-486 with respect to overall and relapse-free survival were shown in most subgroups defined according to baseline characteristics. The most common adverse events in both groups were grade 1 or 2 gastrointestinal events. Common grade 3 or 4 adverse events were neutropenia (in 41% of patients in the CC-486 group and 24% of patients in the placebo group) and thrombocytopenia (in 22% and 21%, respectively). Overall health-related quality of life was preserved during CC-486 treatment. Conclusions: CC-486 maintenance therapy was associated with significantly longer overall and relapse-free survival than placebo among older patients with AML who were in remission after chemotherapy. Side effects were mainly gastrointestinal symptoms and neutropenia. Quality-of-life measures were maintained throughout treatment. (Supported by Celgene; QUAZAR AML-001 ClinicalTrials.gov number, NCT01757535.).pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationN Engl J Med . 2020 Dec 24;383(26):2526-2537.pt_PT
dc.identifier.doi10.1056/NEJMoa2004444pt_PT
dc.identifier.urihttp://hdl.handle.net/10400.17/4710
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherMassachusetts Medical Societypt_PT
dc.subjectHSAC HEMpt_PT
dc.subjectAgedpt_PT
dc.subjectHumanspt_PT
dc.subjectMalept_PT
dc.subjectFemalept_PT
dc.subjectAdministration, Oralpt_PT
dc.subjectAged, 80 and overpt_PT
dc.subjectMiddle Agedpt_PT
dc.subjectAntimetabolites, Antineoplastic / administration & dosagept_PT
dc.subjectAntimetabolites, Antineoplastic / adverse effectspt_PT
dc.subjectAntimetabolites, Antineoplastic / therapeutic use*pt_PT
dc.subjectAntineoplastic Combined Chemotherapy Protocols / therapeutic usept_PT
dc.subjectAzacitidine / administration & dosagept_PT
dc.subjectAzacitidine / adverse effectspt_PT
dc.subjectAzacitidine / therapeutic use*pt_PT
dc.subjectDouble-Blind Methodpt_PT
dc.subjectDrug Administration Schedulept_PT
dc.subjectLeukemia, Myeloid, Acute / drug therapy*pt_PT
dc.subjectLeukemia, Myeloid, Acute / mortalitypt_PT
dc.subjectMaintenance Chemotherapy* / adverse effectspt_PT
dc.subjectNausea / chemically inducedpt_PT
dc.subjectQuality of Lifept_PT
dc.subjectRemission Inductionpt_PT
dc.subjectSurvival Analysispt_PT
dc.titleOral Azacitidine Maintenance Therapy for Acute Myeloid Leukemia in First Remissionpt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.endPage2537pt_PT
oaire.citation.issue26pt_PT
oaire.citation.startPage2526pt_PT
oaire.citation.titleNew England Journal of Medicinept_PT
oaire.citation.volume383pt_PT
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT

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