Evidence map›Paper›PMID 27795561›Full record

Trial reportLeukemia2017

A clinical trial for patients with acute myeloid leukemia or myelodysplastic syndromes not eligible for standard clinical trials.

G Montalban-Bravo, X Huang, K Naqvi, E Jabbour, G Borthakur, C D DiNardo, N Pemmaraju, J Cortes, S Verstovsek, T Kadia and 18 more

Erratum issuedAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  6. Epigenetic Targeting in Myeloid Malignancies.Advances in experimental medicine and biology · 2026
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

28 authors.

G Montalban-BravoDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
X HuangDepartment of Biostatistics, University of Texas, MD Anderson Cancer Center, Houston, TX, USA.
K NaqviDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
E JabbourDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
G BorthakurDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
C D DiNardoDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
N PemmarajuDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
J CortesDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
S VerstovsekDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
T KadiaDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
N DaverDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
W WierdaDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Y AlvaradoDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
M KonoplevaDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
F RavandiDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Z EstrovDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
N JainDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
A AlfonsoDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
M BrandtDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
T SneedDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
H-C ChenDepartment of Biostatistics, University of Texas, MD Anderson Cancer Center, Houston, TX, USA.
H YangDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
C Bueso-RamosDepartment of Hematopathology, University of Texas, MD Anderson Cancer Center, Houston, TX, USA.
S PierceDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
E EsteyDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Z BohannanDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
H M KantarjianDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
G Garcia-ManeroDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Funding

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

Abstract

Most clinical trials exclude patients with poor performance or comorbidities. To study whether patients with these characteristics can be treated within a clinical trial, we conducted a study for patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) with poor performance, organ dysfunction or comorbidities. Primary endpoint was 60-day survival. Study included stopping rules for survival and response. Treatment consisted on a combination of azacitidine and vorinostat. Thirty patients (16 with MDS, 14 with AML) were enrolled. Median follow-up was 7.4 months (0.3-29). Sixty-day survival was 83%. No stopping rules were met. Main adverse events (AEs) were grades 1 and 2 gastrointestinal toxicities. In view of these results, we expanded the study and treated 79 additional patients: 27 with azacitidine (AZA) and 52 with azacitidine and vorinostat (AZA+V). Median follow-up was 22.7 months (12.6-47.5). Sixty-day survival rate was 79% (AZA=67%, AZA+V=85%, P=0.07). Median overall survival was 7.6 months (4.5-10.7). Median event-free survival was 4.5 months (3.5-5.6). Main AEs included grades 1 and 2 gastrointestinal toxicities. Our results suggest this subset of patients can be safely treated within clinical trials and derive clinical benefit. Relaxation of standard exclusion criteria may increase the pool of patients likely to benefit from therapy.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiomarkersBone MarrowChromosome AberrationsComorbidityFemaleFollow-Up StudiesHumansKaplan-Meier EstimateLeukemia, Myeloid, AcuteMaleMiddle AgedMyelodysplastic SyndromesBiomarkers

Identifiers

PMID27795561

What OpenQuestion holds

Textmetadata
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Registered trials

None linked

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.