Evidence map›Paper›PMID 20672358›Full record

ArticleCancer2010

Maintenance therapy with low-dose azacitidine after allogeneic hematopoietic stem cell transplantation for recurrent acute myelogenous leukemia or myelodysplastic syndrome: a dose and schedule finding study.

Marcos de Lima, Sergio Giralt, Peter F Thall, Leandro de Padua Silva, Roy B Jones, Krishna Komanduri, Thomas M Braun, Hoang Q Nguyen, Richard Champlin, Guillermo Garcia-Manero

3 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase I
In one paragraph

Article in Cancer, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 194 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
194citing papers in PubMed, 2 pooled it
18.5field-weighted citation impact, top 1% 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.

NCT01277484 phase1unknown statusnot on this mapstarted 2011, after this paper: background citation

Single Arm, Open Label, Phase I Study for Dose and Schedule Finding of Decitabine in Patients With Higher-risk MDS and MDS/AML Receiving Allogeneic Stem Cell Transplantation

TypeinterventionalSponsorSeoul St. Mary's HospitalRan2011 to 2015Enrolled19ConditionsMyelodysplastic Syndrome, Acute Myeloid LeukemiaArmsDecitabine
NCT01617226 phase2completednot on this mapstarted 2012, after this paper: background citation

Phase II Randomised Trial of 5-azacitidine Versus 5-azacitidine in Combination With Vorinostat in Patients With Acute Myeloid Leukaemia or High Risk Myelodysplastic Syndromes Ineligible for Intensive Chemotherapy

TypeinterventionalSponsorUniversity of BirminghamRan2012 to 2020Enrolled260ConditionsLeukemia, Myeloid, AcuteArmsAzacitidine, Vorinostat
NCT05381038 phase1 / phase2recruitingnot on this mapstarted 2023, after this paper: background citation

Optimizing and Personalising Azacitidine Combination Therapy for Treating Solid Tumours Using the Quadratic Phenotypic Optimization Platform (QPOP) and an Artificial Intelligence-based Platform (CURATE.AI)

TypeinterventionalSponsorNational University Hospital, SingaporeRan2023 to 2027Enrolled10ConditionsSolid Tumor, Gastrointestinal Cancer, Breast CancerArmsQPOP, CURATE.AI, Azacitidine + docetaxel, Azacitidine + paclitaxel, Azacitidine + irinotecan
3 · Its place in the literature

Who cites it

194 citing papers in PubMed, 2 syntheses or guidelines pooled it, 427 citations in OpenAlex.

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  11. Reduced-Intensity Conditioning Followed by Related and Unrelated Allografts for Hematologic Malignancies: Expanded Analysis and Long-Term Follow-Up.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2019
    Trial
  12. CC-486 Maintenance after Stem Cell Transplantation in Patients with Acute Myeloid Leukemia or Myelodysplastic Syndromes.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2018
    Trial
  13. Reduced-Intensity Haploidentical Bone Marrow Transplantation with Post-Transplant Cyclophosphamide for Solid Tumors in Pediatric and Young Adult Patients.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2017
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  18. Dose intensification of busulfan in the preparative regimen is associated with improved survival: a phase I/II controlled, randomized study.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2013
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134 more citing papers are in PubMed but not listed here.

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

10 authors at 3 institutions in 1 country.

Marcos de LimaDepartment of Stem Cell Transplantation and Cell Therapy, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030, USA. mdelima@mdanderson.org
Sergio Giralt
Peter F Thall
Leandro de Padua Silva
Roy B Jones
Krishna Komanduri
Thomas M Braun
Hoang Q Nguyen
Richard Champlin
Guillermo Garcia-Manero
The University of Texas MD Anderson Cancer Center · USUniversity of Miami · USUniversity of Michigan–Ann Arbor · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
STATISTICAL METHODS FOR COMPLEX CANCER TRIALSR01CA083932 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI THALL, PETER F · 2000 to 2017
$2.3M
NCI NIH HHS P30 CA016672NCI NIH HHS R01 CA083932
6 · The paper itself

Abstract

backgroundRecurrence is a major cause of treatment failure after allogeneic transplantation for acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS), and treatment options are very limited. Azacitidine is a DNA methyltransferase inhibitor with activity in myeloid disease. The authors hypothesized that low-dose azacitidine administered after transplant would reduce recurrence rates, and conducted a study to determine a safe dose/schedule combination.

methodsForty-five high-risk patients were treated. Median age was 60 years; median number of comorbidities was 3; 67% were not in remission. By using a Bayesian adaptive method to determine the best dose/schedule combination based on time to toxicity, the authors investigated combinations of 5 daily azacitidine doses, 8, 16, 24, 32, and 40 mg/m2, and 4 schedules: 1, 2, 3, or 4 cycles, each with 5 days of drug and 25 days of rest. Cycle 1 started on Day +40.

resultsReversible thrombocytopenia was the dose-limiting toxicity. The optimal combination was 32 mg/m2 given for 4 cycles. Median follow-up was 20.5 months. One-year event-free and overall survival were 58% and 77%, justifying further studies to estimate long-term clinical benefit. No dose significantly affected DNA global methylation.

conclusionsAzacitidine at 32 mg/m2 given for 5 days is safe and can be administered after allogeneic transplant for at least 4 cycles to heavily pretreated AML/MDS patients. The trial also suggested that this treatment may prolong event-free and overall survival, and that more cycles may be associated with greater benefit.

Indexed as

Hematopoietic Stem Cell TransplantationAdultAgedAzacitidineDisease-Free SurvivalDNA MethylationDrug Administration ScheduleFemaleGraft vs Host DiseaseHumansLeukemia, Myeloid, AcuteMaleMiddle AgedMyelodysplastic SyndromesRecurrenceTransplantation, HomologousAzacitidine

Identifiers

PMID20672358
PMCPMC5669059
OpenAlexW1796660362

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.