Evidence map›Paper›PMID 25828745›Full record

Trial reportLeukemia research2015

Discontinuation of hypomethylating agent therapy in patients with myelodysplastic syndromes or acute myelogenous leukemia in complete remission or partial response: retrospective analysis of survival after long-term follow-up.

Monica Cabrero, Elias Jabbour, Farhad Ravandi, Zach Bohannan, Sherry Pierce, Hagop M Kantarjian, Guillermo Garcia-Manero

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Leukemia research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04806906 (A Phase 2, Monocentric, Pilot Study to Evaluate Safety and Efficacy of CC 486), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT04806906 phase2completednot on this mapstarted 2021, after this paper: background citation

A Phase 2, Monocentric, Pilot Study to Evaluate Safety and Efficacy of CC 486 (Oral Azacitidine) Plus Best Supportive Care as Maintenance of Response to sc Azacitidine in IPSS Higher Risk Elderly MDS Patients

TypeinterventionalSponsorUniversity of FlorenceRan2021 to 2025Enrolled11ConditionsMDS, CMMLArmsCC-486
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Article
  8. Oral hypomethylating agents: beyond convenience in MDS.Hematology. American Society of Hematology. Education Program · 2021
    Article
  9. Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Treatment options for patients with myelodysplastic syndromes after hypomethylating agent failure.Hematology. American Society of Hematology. Education Program · 2016
    Review
  15. 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

7 authors.

Monica CabreroDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.
Elias JabbourDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.
Farhad RavandiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.
Zach BohannanDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.
Sherry PierceDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.
Hagop M KantarjianDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.
Guillermo Garcia-ManeroDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, United States. Electronic address: ggarciam@mdanderson.org.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

Hypomethylating agents (HMA), such as 5-azacitidine or decitabine, are currently used to treat patients with myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) until treatment failure. However, the outcomes for patients who discontinue therapy after achieving partial response (PR) or complete remission (CR) but before treatment failure have not been reported. We present a series of 16 patients with higher-risk MDS (n=5; 31%) or AML (n=11; 69%) who achieved PR (n=1) or CR (n=15) and stopped HMA therapy while in response in the context of clinical trials. They received a median of 12 courses (range 1-24) and achieved response after a median of 1 course of therapy (1-4). Loss of response after discontinuation of therapy was rapid, with a median progression-free survival of 4 months (95% CI: 2-6). Median overall survival (OS) from the time of therapy discontinuation was 15 months (95% CI: 6-24). Patients who received 12 cycles of therapy or more had significantly better OS (median: 20 months [95% CI: 12-27]) than those who received fewer than 12 cycles (median: 4 months [95% CI: 1-8]) (p=0.043). Poor-risk cytogenetics were also associated with lower 1-year OS (33% versus 69%; p=0.046). According to these results and considering the poor prognosis after HMA failure, HMA interruption should be avoided once a sustained response has been achieved.

Indexed as

AgedAged, 80 and overAntimetabolites, AntineoplasticAzacitidineDecitabineDNA MethylationFollow-Up StudiesHumansLeukemia, Myeloid, AcuteMiddle AgedMyelodysplastic SyndromesRemission InductionRetrospective StudiesSurvival AnalysisTreatment OutcomeWithholding TreatmentAntimetabolites, AntineoplasticAzacitidineDecitabineHypomethylating agentsMyelodysplastic syndromesTreatment discontinuation

Identifiers

PMID25828745
PMCPMC4826042

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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.