Evidence map›Paper›PMID 20136825›Full record

Trial reportBritish journal of haematology2010

Prolonged survival with improved tolerability in higher-risk myelodysplastic syndromes: azacitidine compared with low dose ara-C.

Pierre Fenaux, Norbert Gattermann, John F Seymour, Eva Hellström-Lindberg, Ghulam J Mufti, Ulrich Duehrsen, Steven D Gore, Fernando Ramos, Odile Beyne-Rauzy, Alan List and 3 more

Erratum issued 2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of haematology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed
5.8field-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.

NCT00071799 phase3completednot on this map

A Multicenter, Randomized, Open-label, Parallel-group, Phase 3 Trial of Subcutaneous Azacitidine Plus Best Supportive Care Versus Conventional Care Regimens Plus Best Supportive Care for the Treatment of Myelodysplastic Syndromes (MDS)

TypeinterventionalSponsorCelgeneRan2003 to 2007Enrolled358ConditionsMyelodysplastic SyndromesArmsAzacitidine, Physician Choice
NCT01869114 phase2completednot on this mapstarted 2013, after this paper: background citation

A Phase II Study of Azacitidine and Sirolimus for the Treatment of High Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Refractory to or Not Eligible for Intensive Chemotherapy

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityRan2013 to 2024Enrolled57ConditionsAdult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13, q22)ArmsSirolimus, Azacitidine
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 74 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Article
  6. In MDS, is higher risk higher reward?Hematology. American Society of Hematology. Education Program · 2019
    Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Review
  15. Review
  16. Review
  17. Review
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

13 authors at 10 institutions in 7 countries.

Pierre FenauxHôpital Avicenne, Assistance Publique-Hôpitaux de Paris and Paris 13 University, Bobigny, France. pierre.fenaux@avc.aphp.fr
Norbert Gattermann
John F Seymour
Eva Hellström-Lindberg
Ghulam J Mufti
Ulrich Duehrsen
Steven D Gore
Fernando Ramos
Odile Beyne-Rauzy
Alan List
David McKenzie
Jay Backstrom
Charles L Beach
Essen University Hospital · DEHeinrich Heine University Düsseldorf · DEHôpital Avicenne · FRHôpital Purpan · FRKarolinska University Hospital · SEKing's College London · GBMoffitt Cancer Center · USSidney Kimmel Comprehensive Cancer Center · USUniversidad de León · ESUniversity of Melbourne · AU

Funding

Targeting Epigenomics in Myeloid NeoplasmsK24CA111717 · NCI · YALE UNIVERSITY · PI GORE, STEVEN D · 2005 to 2015
$1.7M
NCI NIH HHS K24 CA111717
6 · The paper itself

Abstract

In the phase III AZA-001 trial, low-dose cytarabine (LDara-C), the most widely used low-dose chemotherapy in patients with higher-risk myelodysplastic syndrome (MDS) who are ineligible for intensive treatment, was found to be associated with poorer survival compared with azacitidine. This analysis further compared the efficacy and the toxicity of these two drug regimens. Before randomization, investigators preselected patients to receive a conventional care regimen, one of which was LDara-C. Of 94 patients preselected to LDara-C, 45 were randomized to azacitidine and 49 to LDara-C. Azacitidine patients had significantly more and longer haematological responses and increased red blood cell transfusion independence. Azacitidine prolonged overall survival versus LDara-C in patients with poor cytogenetic risk, presence of -7/del(7q), and French-American-British subtypes refractory anaemia with excess blasts (RAEB) and RAEB in transformation. When analyzed per patient year of drug exposure, azacitidine treatment was associated with fewer grade 3-4 cytopenias and shorter hospitalisation time than LDara-C in these higher-risk MDS patients.

Indexed as

AdultAgedAged, 80 and overAntimetabolites, AntineoplasticAzacitidineCytarabineDrug Administration ScheduleErythrocyte TransfusionFemaleHumansMaleMiddle AgedMyelodysplastic SyndromesSurvival AnalysisTreatment OutcomeAntimetabolites, AntineoplasticAzacitidineCytarabine

Identifiers

PMID20136825
PMCPMC4000023
OpenAlexW2080584244

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.