Evidence map›Paper›PMID 27619199›Full record

Trial reportLeukemia research2016

Differentiation therapy in poor risk myeloid malignancies: Results of companion phase II studies.

Kelly J Norsworthy, Eunpi Cho, Jyoti Arora, Jeanne Kowalski, Hua-Ling Tsai, Erica Warlick, Margaret Showel, Keith W Pratz, Lesley A Sutherland, Steven D Gore and 7 more

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

Trial report in Leukemia research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.1field-weighted citation impact, top 19% 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

4 citing papers in PubMed, 12 citations in OpenAlex.

  1. Review
  2. Immunotherapy in AML: a brief review on emerging strategies.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2021
    Review
  3. Review
  4. The Roles of Histone Deacetylases and Their Inhibitors in Cancer Therapy.Frontiers in cell and developmental biology · 2020
    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

17 authors at 3 institutions in 1 country.

Kelly J NorsworthyJohns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, United States.
Eunpi ChoJohns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, United States.
Jyoti AroraBiostatistics and Bioinformatics Shared Resource, Winship Cancer Institute of Emory University, Atlanta, GA, United States.
Jeanne KowalskiBiostatistics and Bioinformatics Shared Resource, Winship Cancer Institute of Emory University, Atlanta, GA, United States.
Hua-Ling TsaiJohns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, United States.
Erica WarlickJohns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, United States.
Margaret ShowelJohns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, United States.
Keith W PratzJohns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, United States.
Lesley A SutherlandJohns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, United States.
Steven D GoreJohns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, United States.
Anna FergusonJohns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, United States.
Sarah SakoianJohns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, United States.
Jackie GreerJohns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, United States.
Igor Espinoza-DelgadoCancer Therapy Evaluation Program, National Cancer Institute, Rockville, MD, United States.
Richard J JonesJohns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, United States.
William H MatsuiJohns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, United States.
B Douglas SmithJohns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, United States. Electronic address: bdsmith@jhmi.edu.
Sidney Kimmel Comprehensive Cancer Center · USJohns Hopkins University · USNational Cancer Institute · US

Funding

TUMOR VACCINESP01CA015396 · NCI · JOHNS HOPKINS UNIVERSITY · PI LEVITSKY, HYAM ISAAC · 1985 to 2016
$38.1M
Targeting Epigenomics in Myeloid NeoplasmsK24CA111717 · NCI · YALE UNIVERSITY · PI GORE, STEVEN D · 2005 to 2015
$1.7M
NCI NIH HHS K24 CA111717NCI NIH HHS P01 CA015396
6 · The paper itself

Abstract

Pre-clinical data in non-M3 AML supports the use of differentiation therapy, but clinical activity has been limited. Myeloid growth factors can enhance anti-leukemic activity of differentiating agents in vitro. We conducted companion phase II trials investigating sargramostim (GM-CSF) 125μg/m(2)/day plus 1) bexarotene (BEX) 300mg/m(2)/day or 2) entinostat (ENT) 4-8mg/m(2)/week in patients with MDS or relapsed/refractory AML. Primary endpoints were response after at least two treatment cycles and toxicity. 26 patients enrolled on the BEX trial had a median of 2 prior treatments and 24 enrolled on the ENT trial had a median of 1. Of 13 response-evaluable patients treated with BEX, the best response noted was hematologic improvement in neutrophils (HI-N) seen in 4 (31%) patients; none achieved complete (CR) or partial remission (PR). Of 10 treated with ENT, there was 1 (10%) partial remission (PR) and 2 (20%) with HI-N. The secondary endpoint responses of HI-N with each combination were accompanied by a numerical increase in ANC (BEX: 524 to 931 cells/mm(3), p=0.096; ENT: 578 to 1 137 cells/mm(3), p=0.15) without increasing marrow blasts. Shared grade 3-4 non-hematologic toxicities included febrile neutropenia, bone pain, fatigue, and dyspnea. GM-CSF plus either BEX or ENT are well tolerated in resistant and refractory MDS and AML and showed modest clinical and biologic activity, most commonly HI-N.

Indexed as

AgedAged, 80 and overAntineoplastic AgentsBenzamidesBexaroteneFemaleGranulocyte-Macrophage Colony-Stimulating FactorHL-60 CellsHumansLeukemia, Myeloid, AcuteMaleMiddle AgedMyelodysplastic SyndromesNeutrophilsPyridinesRecombinant ProteinsAntineoplastic AgentsBenzamidesBexaroteneentinostatGranulocyte-Macrophage Colony-Stimulating FactorPyridinesRecombinant ProteinssargramostimTetrahydronaphthalenesAcute myeloid leukemiaBexaroteneDifferentiationEntinostatMyelodysplastic syndrome

Identifiers

PMID27619199
PMCPMC8829813
OpenAlexW2515783719

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.