Evidence map›Paper›PMID 26577691›Full record

Trial reportBritish journal of haematology2016

Azacitidine with or without Entinostat for the treatment of therapy-related myeloid neoplasm: further results of the E1905 North American Leukemia Intergroup study.

Thomas Prebet, Zhuoxin Sun, Rhett P Ketterling, Amer Zeidan, Peter Greenberg, James Herman, Mark Juckett, Mitchell R Smith, Lisa Malick, Elisabeth Paietta and 8 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of haematology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00313586 (A Randomized Phase II Trial of Azacitidine With or Without the Histone Deacetylase Inhibitor Entinostat for the Treatment of Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia), which is not on this map. Cited by 38 papers.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed
5.9field-weighted citation impact, top 3% 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.

NCT00313586 phase2completednot on this map

A Randomized Phase II Trial of Azacitidine With or Without the Histone Deacetylase Inhibitor Entinostat for the Treatment of Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (Dysplastic Type), and Acute Myeloid Leukemia With Multilineage Dysplasia

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2006 to 2013Enrolled197ConditionsAcute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22), CBFB-MYH11ArmsAzacitidine, Entinostat, Laboratory Biomarker Analysis
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 106 citations in OpenAlex.

  1. Trial
  2. Review
  3. Epigenetic Targeting in Myeloid Malignancies.Advances in experimental medicine and biology · 2026
    Review
  4. Review
  5. Review
  6. Review
  7. Epigenetics-targeted drugs: current paradigms and future challenges.Signal transduction and targeted therapy · 2024
    Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. Article
  13. Frontline treatment options for higher-risk MDS: can we move past azacitidine?Hematology. American Society of Hematology. Education Program · 2023
    Article
  14. Review
  15. Article
  16. TargetingOncoTargets and therapy · 2022
    Review
  17. Review
  18. Review
  19. Review
  20. Review
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

18 authors at 13 institutions in 1 country.

Thomas PrebetSection of Hematology, Yale Cancer Center, New Haven, CT, USA.ORCID http://orcid.org/0000-0002-6872-625X
Zhuoxin SunECOG-ACRIN Biostatistics Center, Dana-Farber Cancer Institute, Boston, MA, USA.
Rhett P KetterlingDepartment of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.
Amer ZeidanSection of Hematology, Yale Cancer Center, New Haven, CT, USA.
Peter GreenbergHematology Division, Stanford University Cancer Center, Stanford, CA, USA.
James HermanJohns Hopkins University, Baltimore, MD, USA.
Mark JuckettUniversity of Wisconsin, Madison, WI, USA.
Mitchell R SmithCleveland Clinic, Cleveland, OH, USA.
Lisa MalickJohns Hopkins University, Baltimore, MD, USA.
Elisabeth PaiettaNorth Division, Montefiore Medical Center, Bronx, NY, USA.
Magdalena CzaderIndiana University Cancer Center, Indianapolis, IN, USA.
Maria FigueroaUniversity of Michigan Medical School, Ann Arbor, MI, USA.
Janice GabriloveThe Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai School of Medicine, New York, NY, USA.
Harry P ErbaUniversity of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.
Martin S TallmanLeukemia Service, Memorial Sloane-Kettering Cancer Center, New York, NY, USA.
Mark LitzowDivision of Hematology, Mayo Clinic Cancer Center, Mayo Clinic College of Medicine, Rochester, MN, USA.
Steven D GoreSection of Hematology, Yale Cancer Center, New Haven, CT, USA.
Eastern Cooperative Oncology Group and North American Leukemia intergroup
Yale Cancer Center · USJohns Hopkins University · USUniversity of Michigan · USCleveland Clinic · USDana-Farber Cancer Institute · USIndiana University Melvin and Bren Simon Comprehensive Cancer CenterMayo Clinic · USMayo Clinic in Arizona · USMemorial Sloan Kettering Cancer Center · USMontefiore Medical Center · USStanford University · USTisch Hospital · USUniversity of Wisconsin–Madison · US

Funding

Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO · 2014 to 2026
$111.2M
ECOG-ACRIN Biospecimen Bank to Support NCTNU24CA196172 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI STANLEY R. HAMILTON, Scott D Jewell · 2015 to 2026
$41.1M
Network Lead Academic Participating Site: Memorial Sloan-Kettering Cancer CenterU10CA180791 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI AGHAJANIAN, CAROL, MORRIS, MICHAEL J · 2014 to 2018
$4.6M
SOUTHWEST ONCOLOGY GROUPU10CA027057 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI SCHOTT, ANNE F · 1985 to 2013
$4.0M
UM LAPs- U10 GrantU10CA180801 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ZALUPSKI, MARK M · 2014 to 2018
$3.7M
National Clinical Trials Network Research at the University of WisconsinU10CA180799 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI ANDERSON, BETHANY M, KUSHNER, DAVID M · 2014 to 2018
$2.8M
NCTN Deep South Research ConsortiumU10CA180855 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI BJORNSTI, MARY-ANN, FALKSON, CARLA I · 2014 to 2018
$2.6M
Targeting Epigenomics in Myeloid NeoplasmsK24CA111717 · NCI · YALE UNIVERSITY · PI GORE, STEVEN D · 2005 to 2015
$1.7M
NCI NIH HHS K24 CA111717NCI NIH HHS N01 CA027057NCI NIH HHS N01 CA032102NCI NIH HHS R01 CA1255635-01NCI NIH HHS R01 CA125635NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA027057NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA180791NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180799NCI NIH HHS U10 CA180801NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180855NCI NIH HHS U10 CA180888NCI NIH HHS U24 CA196172
6 · The paper itself

Abstract

Therapy-related myeloid neoplasms (tMN) are serious late effects of the treatment of cancer with poor response to conventional treatment. Azacitidine (AZA) has been used to treat patients with tMN but current data are retrospective. We present here 47 tMN patients prospectively enrolled as a specific cohort in the E1905 study. TheE1905 study was a randomized phase 2 study (NCT00313586) testing 10 d of AZA (50 mg/m(2) /d) +/- the histone deacetylase inhibitor entinostat (4 mg/m(2) /d PO day-3 and day-10). A total of 47 patients [29 therapy-related myelosyspastic syndrome (t-MDS) and 18 therapy-related acute myeloid leukaemia (t-AML)] were recruited to the study. 24 patients were treated with AZA monotherapy and 23 with AZA+entinostat. The median number of administered cycles was 4, significantly higher in patients treated with AZA (6 cycles vs. 3 cycles, P = 0·008). Haematological normalization rates were 46% in monotherapy and 17% in the combination arm. Median overall survivals were 13 and 6 months, respectively. The novel 50 * 10 schedule of azacitidine appears effective, with response rates, when given as single agent, comparable to those for patients with de novo MDS/AML treated on the same protocol. However, the combination of AZA and entinostat was associated with increased toxicity and could not be recommended for treatment of tMN.

Indexed as

AdultAgedAged, 80 and overAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsAzacitidineBenzamidesDrug Administration ScheduleFemaleHumansKaplan-Meier EstimateLeukemia, Myeloid, AcuteMaleMiddle AgedMyelodysplastic SyndromesNeoplasms, Second PrimaryAntimetabolites, AntineoplasticAzacitidineBenzamidesentinostatPyridinesacute myeloid leukaemiaazacitidinehistone deacetylase inhibitormyelodysplasiatherapy related

Identifiers

PMID26577691
PMCPMC4794257
OpenAlexW2178087063

What OpenQuestion holds

Textmetadata
LicenceTDM
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.