Evidence map›Paper›PMID 26365212›Full record

Trial reportLeukemia2016

A phase II study of decitabine and gemtuzumab ozogamicin in newly diagnosed and relapsed acute myeloid leukemia and high-risk myelodysplastic syndrome.

N Daver, H Kantarjian, F Ravandi, E Estey, X Wang, G Garcia-Manero, E Jabbour, M Konopleva, S O'Brien, S Verstovsek and 8 more

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Leukemia, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 3 pooled it
6.5field-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.

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

44 citing papers in PubMed, 3 syntheses or guidelines pooled it, 73 citations in OpenAlex.

  1. Prevalence of antibody drug conjugated-induced nausea and vomiting (ADCINV) in patients with cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
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  9. Vaccines: a promising therapy for myelodysplastic syndrome.Journal of hematology & oncology · 2024
    Review
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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

18 authors at 2 institutions in 1 country.

N DaverDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
H KantarjianDepartment 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.
E EsteyDivision of Hematology, University of Washington School of Medicine, Seattle, WA, USA.
X WangDepartment of Biostatistics, 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.
E JabbourDepartment 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.
S O'BrienDepartment 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.
C DinardoDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
S PierceDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
X HuangDepartment 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.
M Diaz-Pines-MateoDepartment 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.
G BorthakurDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
The University of Texas MD Anderson Cancer Center · USUniversity of Washington · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
University of Texas M.D. Anderson Cancer SPORE-LeukemiaP50CA100632 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI KONOPLEVA, MARINA Y · 2003 to 2023
$43.7M
NCI NIH HHS P30 CA016672NCI NIH HHS P50 CA100632
6 · The paper itself

Abstract

Decitabine may open the chromatin structure of leukemia cells making them accessible to the calicheamicin epitope of gemtuzumab ozogamicin (GO). A total of 110 patients (median age 70 years; range 27-89 years) were treated with decitabine and GO in a trial designed on model-based futility to accommodate subject heterogeneity: group 1: relapsed/refractory acute myeloid leukemia (AML) with complete remission duration (CRD) <1 year (N=28, 25%); group 2: relapsed/refractory AML with CRD ⩾1 year (N=5, 5%); group 3: untreated AML unfit for intensive chemotherapy or untreated myelodysplastic syndrome (MDS) or untreated myelofibrosis (MF; N=57, 52%); and group 4: AML evolving from MDS or relapsed/refractory MDS or MF (N=20, 18%). Treatment consisted of decitabine 20 mg/m(2) daily for 5 days and GO 3 mg/m(2) on day 5. Post-induction therapy included five cycles of decitabine+GO followed by decitabine alone. Complete remission (CR)/CR with incomplete count recovery was achieved in 39 (35%) patients; group 1= 5/28 (17%), group 2=3/5 (60%), group 3=24/57 (42%) and group 4=7/20 (35%). The 8-week mortality in groups 3 and 4 was 16% and 10%, respectively. Common drug-related adverse events included nausea, mucositis and hemorrhage. Decitabine and GO improved the response rate but not overall survival compared with historical outcomes in untreated AML ⩾60 years.

Indexed as

AdultAgedAged, 80 and overAminoglycosidesAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsAzacitidineDecitabineFemaleGemtuzumabHumansLeukemia, Myeloid, AcuteMaleMiddle AgedMyelodysplastic SyndromesSialic Acid Binding Ig-like Lectin 3AminoglycosidesAntibodies, Monoclonal, HumanizedAzacitidineCD33 protein, humanDecitabineGemtuzumabSialic Acid Binding Ig-like Lectin 3

Identifiers

PMID26365212
PMCPMC4790089
OpenAlexW2192207543

What OpenQuestion holds

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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.