Evidence map›Paper›PMID 20368434›Full record

Trial reportProceedings of the National Academy of Sciences of the United States of America2010

Clinical response and miR-29b predictive significance in older AML patients treated with a 10-day schedule of decitabine.

William Blum, Ramiro Garzon, Rebecca B Klisovic, Sebastian Schwind, Alison Walker, Susan Geyer, Shujun Liu, Violaine Havelange, Heiko Becker, Larry Schaaf and 12 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Proceedings of the National Academy of Sciences of the United States of America, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02698124 (Prospective Observation of the indUction Regimen for Acute Non-Promyelocytic Myeloid Leukemia in Elderly; Decitabine for Chemotherapy Unfit Korean Acute Myeloid Leukemia), which is not on this map. Cited by 229 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
229citing papers in PubMed, 2 pooled it
23.8field-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.

NCT02698124 unknown statusnot on this mapstarted 2016, after this paper: background citation

Prospective Observation of the indUction Regimen for Acute Non-Promyelocytic Myeloid Leukemia in Elderly; Decitabine for Chemotherapy Unfit Korean Acute Myeloid Leukemia (AML) Patients in Real Practice

TypeobservationalSponsorUlsan University HospitalRan2016 to 2022Enrolled136ConditionsAcute Myeloid Leukemia, Elderly, Intensive Chemotherapy UnfitArmsDecitabine
3 · Its place in the literature

Who cites it

229 citing papers in PubMed, 2 syntheses or guidelines pooled it, 453 citations in OpenAlex.

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169 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

22 authors at 2 institutions in 1 country.

William BlumDivision of Hematology and Oncology, Department of Medicine, and Center for Biostatistics, Ohio State University Comprehensive Cancer Center, Columbus, OH 43210, USA. william.blum@osumc.edu
Ramiro Garzon
Rebecca B Klisovic
Sebastian Schwind
Alison Walker
Susan Geyer
Shujun Liu
Violaine Havelange
Heiko Becker
Larry Schaaf
Jon Mickle
Hollie Devine
Cheryl Kefauver
Steven M Devine
Kenneth K Chan
Nyla A Heerema
Clara D Bloomfield
Michael R Grever
John C Byrd
Miguel Villalona-Calero
Carlo M Croce
Guido Marcucci
The Ohio State University · USCancer Genetics (United States) · US

Funding

Translational Training Grant in Experimental TherapeuticsK12CA133250 · NCI · OHIO STATE UNIVERSITY · PI WILLIAM E. CARSON, Rosa Lapalombella · 2008 to 2026
$15.0M
SPORE Leukemia Tissue BankP50CA140158 · NCI · OHIO STATE UNIVERSITY · PI BLOOMFIELD, CLARA D · 2009 to 2013
$11.2M
PHARMACOLOGICAL MODULATION OF EPIGENETIC CHANTGES IN AMLR01CA102031 · NCI · OHIO STATE UNIVERSITY · PI GUZMAN, MONICA L, MARCUCCI, GUIDO · 2004 to 2017
$3.8M
Experimental Therapeutics in Acute LeukemiasK23CA120708 · NCI · OHIO STATE UNIVERSITY · PI BLUM, WILLIAM G · 2006 to 2010
$649k
NCI NIH HHS K12 CA133250NCI NIH HHS K12CA133250NCI NIH HHS K23 CA120708NCI NIH HHS K23CA120708NCI NIH HHS N01 CM062207NCI NIH HHS N01-CM-62207NCI NIH HHS P50 CA140158NCI NIH HHS R01 CA102031
6 · The paper itself

Abstract

A phase II clinical trial with single-agent decitabine was conducted in older patients (>or=60 years) with previously untreated acute myeloid leukemia (AML) who were not candidates for or who refused intensive chemotherapy. Subjects received low-dose decitabine at 20 mg/m(2) i.v. over 1 h on days 1 to 10. Fifty-three subjects enrolled with a median age of 74 years (range, 60-85). Nineteen (36%) had antecedent hematologic disorder or therapy-related AML; 16 had complex karyotypes (>or=3 abnormalities). The complete remission rate was 47% (n = 25), achieved after a median of three cycles of therapy. Nine additional subjects had no morphologic evidence of disease with incomplete count recovery, for an overall response rate of 64% (n = 34). Complete remission was achieved in 52% of subjects presenting with normal karyotype and in 50% of those with complex karyotypes. Median overall and disease-free survival durations were 55 and 46 weeks, respectively. Death within 30 days of initiation of treatment occurred in one subject (2%), death within 8 weeks in 15% of subjects. Given the DNA hypomethylating effect of decitabine, we examined the relationship of clinical response and pretreatment level of miR-29b, previously shown to target DNA methyltransferases. Higher levels of miR-29b were associated with clinical response (P = 0.02). In conclusion, this schedule of decitabine was highly active and well tolerated in this poor-risk cohort of older AML patients. Levels of miR-29b should be validated as a predictive factor for stratification of older AML patients to decitabine treatment.

Indexed as

AgedAged, 80 and overAntimetabolites, AntineoplasticAzacitidineCohort StudiesDecitabineDisease-Free SurvivalDNA MethylationFemaleHumansKaryotypingLeukemia, Myeloid, AcuteMaleMicroRNAsMiddle AgedRemission InductionAntimetabolites, AntineoplasticAzacitidineDecitabineMicroRNAsMIRN29a microRNA, human

Identifiers

PMID20368434
PMCPMC2867720
OpenAlexW2081391009

What OpenQuestion holds

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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.