Evidence map›Paper›PMID 29241450›Full record

Trial reportBMC cancer2017

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

John F Seymour, Hartmut Döhner, Aleksandra Butrym, Agnieszka Wierzbowska, Dominik Selleslag, Jun Ho Jang, Rajat Kumar, James Cavenagh, Andre C Schuh, Anna Candoni and 11 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in BMC cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01074047 (A Phase 3, Multicenter, Randomized, Open-Label, Study of Azacitidine), which is not on this map. Cited by 36 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 2 pooled it
3.4field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01074047 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Open-Label, Study of Azacitidine (Vidaza®) Versus Conventional Care Regimens for the Treatment of Older Subjects With Newly Diagnosed Acute Myeloid Leukemia

TypeinterventionalSponsorCelgeneRan2010 to 2016Enrolled488ConditionsAcute Myeloid LeukemiaArmsAzacitidine, Conventional Care Regimen
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 2 syntheses or guidelines pooled it, 71 citations in OpenAlex.

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  12. Melatonin: A Potential Regulator of DNA Methylation.Antioxidants (Basel, Switzerland) · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 17 institutions in 11 countries.

John F SeymourDepartment of Haematology, Peter MacCallum Cancer Centre, Locked Bag 1, A'Beckett St, East Melbourne, VIC, 8006, Australia. john.seymour@petermac.org.ORCID http://orcid.org/0000-0003-2188-6835
Hartmut DöhnerUniversitätsklinikum Ulm, Ulm, Germany.
Aleksandra ButrymWroclaw Medical University, Wroclaw, Poland.
Agnieszka WierzbowskaMedical University of Lodz, Lodz, Poland.
Dominik SelleslagAlgemeen Ziekenhuis Sint-Jan, Brugge, Belgium.
Jun Ho JangSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Rajat KumarCancer Care Manitoba, Winnipeg, Canada.
James CavenaghBarts Health National Health Service Trust, London, UK.
Andre C SchuhPrincess Margaret Cancer Centre, Toronto, Canada.
Anna CandoniAzienda Sanitaria Universitaria Integrata di Udine, Udine, Italy.
Christian RécherCentre Hospitalier Universitaire de Toulouse, Toulouse, France.
Irwindeep SandhuUniversity of Alberta Hospital, Edmonton, Canada.
Teresa Bernal Del CastilloHospital Central de Asturias, Oviedo, Spain.
Haifa Kathrin Al-AliUniversity Hospital of Halle, Halle, Germany.
Jose FalantesHospital Universitario Virgen del Rocio/Instituto de BioMedicinia de Sevilla, Sevilla, Spain.
Richard M StoneDana-Farber Cancer Institute, Boston, MA, USA.
Mark D MindenPrincess Margaret Cancer Centre, Toronto, Canada.
Jerry WeaverCelgene Corporation, Summit, NJ, USA.
Steve SongerCelgene Corporation, Summit, NJ, USA.
C L BeachCelgene Corporation, Summit, NJ, USA.
Hervé DombretHôpital Saint Louis, Institut Universitaire d'Hématologie, University Paris Diderot, Paris, France.
Princess Margaret Cancer Centre · CAAlberta Hospital Edmonton · CAAZ Sint-Jan · BECancerCare Manitoba · CACentre Hospitalier Universitaire de Toulouse · FRDana-Farber Cancer Institute · USHospital Universitario Central de Asturias · ESHospital Universitario Virgen del Rocío · ESMedical University of Lodz · PLNational Health Service · GBOspedale Santa Maria della Misericordia di Udine · ITSamsung Medical Center · KRThe University of Melbourne · AUUniversité Paris Cité · FRUniversity Hospital in Halle · DEUniversity Hospital Ulm · DEWroclaw Medical University · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCompared 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.

methodsWe 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).

resultsMedian 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.

conclusionsAzacitidine 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 registrationThis study was registered at clinicalTrials.gov on February 16, 2010 ( NCT01074047 ).

Indexed as

AgedAged, 80 and overAge FactorsAntimetabolites, AntineoplasticAzacitidineCytarabineFemaleHumansKaplan-Meier EstimateLeukemia, Myeloid, AcuteMaleMyelodysplastic SyndromesPrognosisTreatment OutcomeAntimetabolites, AntineoplasticAzacitidineCytarabineAcute myeloid leukaemiaAMLAML-MRCAzacitidineInduction chemotherapyLow-dose cytarabineMyelodysplasia-related changesResponseSurvival

Identifiers

PMID29241450
PMCPMC5731212
OpenAlexW2771627443

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.