Evidence map›Paper›PMID 26522083›Full record

Trial reportLeukemia2016

Azacitidine in combination with intensive induction chemotherapy in older patients with acute myeloid leukemia: The AML-AZA trial of the Study Alliance Leukemia.

C Müller-Tidow, P Tschanter, C Röllig, C Thiede, A Koschmieder, M Stelljes, S Koschmieder, M Dugas, J Gerss, T Butterfaß-Bahloul and 32 more

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
5.7field-weighted citation impact, top 4% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Review
  17. Review
  18. Article
  19. Review
  20. Article
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

42 authors at 20 institutions in 1 country.

C Müller-TidowDepartment of Medicine, Hematology and Oncology, University of Halle, Halle, Germany.
P TschanterDepartment of Medicine, Hematology and Oncology, University of Halle, Halle, Germany.
C RölligDepartment of Internal Medicine I, Dresden University Medical Center, Dresden, Germany.
C ThiedeDepartment of Internal Medicine I, Dresden University Medical Center, Dresden, Germany.
A KoschmiederDepartment of Medicine A - Hematology, Oncology and Pneumology, University of Muenster, Muenster, Germany.
M StelljesDepartment of Medicine A - Hematology, Oncology and Pneumology, University of Muenster, Muenster, Germany.
S KoschmiederDepartment of Medicine A - Hematology, Oncology and Pneumology, University of Muenster, Muenster, Germany.
M DugasInstitute of Medical Informatics, University Hospital of Muenster, Muenster, Germany.
J GerssInstitute of Biometry, University Hospital of Muenster, Muenster, Germany.
T Butterfaß-BahloulCenter for Clinical Trials, University Hospital Muenster, Muenster, Germany.
R WagnerCenter for Clinical Trials, University Hospital Muenster, Muenster, Germany.
M EveslageInstitute of Biometry, University Hospital of Muenster, Muenster, Germany.
U ThiemDepartment of Medical Informatics, Biometry and Epidemiology, University Bochum, Bochum, Germany.
S W KrauseDepartment of Internal Medicine 5, University of Erlangen-Nürnberg Medical Center, Erlangen, Germany.
U KaiserHematology and Oncology, St Bernward Hospital, Hildesheim, Germany.
V KunzmannDepartment of Internal Medicine II, Julius-Maximilians-Universität Würzburg, Würzburg, Germany.
B SteffenDepartment of Medicine, Hematology/Oncology, Goethe University of Frankfurt, Frankfurt, Germany.
R NoppeneyDepartment of Hematology, University of Essen Medical Center, Essen, Germany.
W HerrDepartment for Hematology/Oncology, University of Regensburg, Regensburg, Germany.
C D BaldusDepartment of Hematology and Oncology, Charité Campus Benjamin Franklin, Berlin, Germany.
N SchmitzDepartment of Hematology and Stem Cell Transplantation, ASKLEPIOS Klinik St. Georg, Hamburg, Germany.
K GötzeDepartment of Internal Medicine III, University Hospital of Munich, Munich, Germany.
A ReichleDepartment for Hematology/Oncology, University of Regensburg, Regensburg, Germany.
M KaufmannHematology and Oncology, Robert-Bosch-Krankenhaus, Stuttgart, Germany.
A NeubauerDepartment Hematology, Oncology and Immunology, Philipps University Marburg, Marburg, Germany.
K Schäfer-EckartDepartment of Internal Medicine V, Klinikum Nuernberg Nord, Nuernberg, Germany.
M HänelDepartment of Internal Medicine III, Klinikum Chemnitz GmbH, Chemnitz, Germany.
R PecenyDepartment of Hematology and Oncology, Klinikum Osnabrück, Osnabrück, Germany.
N FrickhofenDepartment of Hematology and Oncology, HSK, Dr -Horst-Schmidt-Klinik, Wiesbaden, Germany.
M KiehlDepartment of Internal Medicine, Frankfurt (Oder) General hospital, Frankfurt/Oder, Germany.
A GiagounidisDepartment of Oncology and Hematology, Marien Hospital Düsseldorf, Duesseldorf, Germany.
M GörnerDepartment of Hematology and Oncology, Städtische Kliniken, Bielefeld, Germany.
R ReppDepartment of Medicine V, Klinikum am Bruderwald, Bamberg, Germany.
H LinkDepartment of Internal Medicine I, Westpfalz-Klinikum, Kaiserslautern, Germany.
A KianiDepartment IV Hematology and Onkology, Klinikum Bayreuth, Bayreuth, Germany.
R NaumannDepartment of Internal Medicine, Stiftungsklinikum Mittelrhein, Koblenz, Germany.
T H BrümmendorfDepartment of Hematology, Oncology, Hemostaseology, and Stem Cell Transplantation, RWTH Aachen University Hospital, Aachen, Germany.
H ServeDepartment of Medicine, Hematology/Oncology, Goethe University of Frankfurt, Frankfurt, Germany.
G EhningerDepartment of Internal Medicine I, Dresden University Medical Center, Dresden, Germany.
W E BerdelDepartment of Medicine A - Hematology, Oncology and Pneumology, University of Muenster, Muenster, Germany.
U KrugDepartment of Medicine A - Hematology, Oncology and Pneumology, University of Muenster, Muenster, Germany.
Study Alliance Leukemia Group
University of Münster · DEGoethe University Frankfurt · DEUniversity Hospital Münster · DEZimmer Biomet (Germany) · DEUniversity of Regensburg · DEAsklepios Klinik St. Georg · DEBayreuth Medical Center · DECharité - Universitätsmedizin Berlin · DEEssen University Hospital · DEFriedrich-Alexander-Universität Erlangen-Nürnberg · DEGemeinschaftsklinikum Mittelrhein · DEHelios Dr. Horst Schmidt Kliniken Wiesbaden · DEKlinikum Arnsberg · DEKlinikum Bielefeld · DEKlinikum Chemnitz · DEKlinikum Osnabrück · DELMU Klinikum · DEMarien Hospital Düsseldorf · DEPhilipps University of Marburg · DERobert Bosch Hospital · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

DNA methylation changes are a constant feature of acute myeloid leukemia. Hypomethylating drugs such as azacitidine are active in acute myeloid leukemia (AML) as monotherapy. Azacitidine monotherapy is not curative. The AML-AZA trial tested the hypothesis that DNA methyltransferase inhibitors such as azacitidine can improve chemotherapy outcome in AML. This randomized, controlled trial compared the efficacy of azacitidine applied before each cycle of intensive chemotherapy with chemotherapy alone in older patients with untreated AML. Event-free survival (EFS) was the primary end point. In total, 214 patients with a median age of 70 years were randomized to azacitidine/chemotherapy (arm-A) or chemotherapy (arm-B). More arm-A patients (39/105; 37%) than arm-B (25/109; 23%) showed adverse cytogenetics (P=0.057). Adverse events were more frequent in arm-A (15.44) versus 13.52 in arm-B, (P=0.26), but early death rates did not differ significantly (30-day mortality: 6% versus 5%, P=0.76). Median EFS was 6 months in both arms (P=0.96). Median overall survival was 15 months for patients in arm-A compared with 21 months in arm-B (P=0.35). Azacitidine added to standard chemotherapy increases toxicity in older patients with AML, but provides no additional benefit for unselected patients.

Indexed as

AgedAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsAzacitidineCytarabineCytogenetic AnalysisDaunorubicinFemaleHumansInduction ChemotherapyLeukemia, Myeloid, AcuteMaleMiddle AgedRemission InductionSurvival AnalysisAntimetabolites, AntineoplasticAzacitidineCytarabineDaunorubicin

Identifiers

PMID26522083
OpenAlexW1904660196

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.