Evidence map›Paper›PMID 28094841›Full record

Trial reportCancer2017

Phase 2, randomized, double-blind study of pracinostat in combination with azacitidine in patients with untreated, higher-risk myelodysplastic syndromes.

Guillermo Garcia-Manero, Guillermo Montalban-Bravo, Jesus G Berdeja, Yasmin Abaza, Elias Jabbour, James Essell, Roger M Lyons, Farhad Ravandi, Michael Maris, Brian Heller and 12 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 54 papers.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed
11.3field-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.

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

54 citing papers in PubMed, 104 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Clinical Trials Assessing Hypomethylating Agents Combined with Other Therapies: Causes for Failure and Potential Solutions.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021
    Trial
  4. Trial
  5. Trial
  6. Therapy of high-risk myelodysplastic syndromes.Bone marrow transplantation · 2026
    Review
  7. Review
  8. Epigenetic Targeting in Myeloid Malignancies.Advances in experimental medicine and biology · 2026
    Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. Mechanisms of HDACs in cancer development.Frontiers in immunology · 2025
    Review
  16. Epigenetics-targeted drugs: current paradigms and future challenges.Signal transduction and targeted therapy · 2024
    Review
  17. Article
  18. Article
  19. Clinical activity, pharmacokinetics, and pharmacodynamics of oral hypomethylating agents for myelodysplastic syndromes/neoplasms and acute myeloid leukemia: A multidisciplinary review.Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners · 2024
    Review
  20. Considerations for Drug Development in Myelodysplastic Syndromes.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 16 institutions in 1 country.

Guillermo Garcia-ManeroDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Guillermo Montalban-BravoDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Jesus G BerdejaSarah Cannon Research Institute, Nashville, Tennessee.
Yasmin AbazaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Elias JabbourDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
James EssellOncology/Hematology Care, Cincinnati, Ohio.
Roger M LyonsCancer Care Center of South Texas, San Antonio, Texas.
Farhad RavandiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Michael MarisColorado Blood Cancer Institute, Denver, Colorado.
Brian HellerSouthern Cancer Center, Daphne, Alabama.
Amy E DeZernSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland.
Sunil BabuFort Wayne Medical Oncology and Hematology, Fort Wain, Indiana.
David WrightFlorida Cancer Specialists-North, Jacksonville, Florida.
Bertrand AnzTennessee Oncology, Chattanooga, Tennessee.
Ralph BocciaCenter for Cancer and Blood Disorders, Bethesda, Maryland.
Rami S KomrokjiH. Lee Moffitt Cancer Center, Tampa, Florida.
Philip KuriakoseDepartment of Internal Medicine, Division of Hematology Oncology, Henry Ford Hospital, Detroit, Michigan.
James ReevesFlorida Cancer Specialists-South, Cape Coral, Florida.
Mikkael A SekeresLeukemia Program, Cleveland Clinic, Cleveland, Ohio.
Hagop M KantarjianDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Richard GhalieMEI Pharma, San Diego, California.
Gail J RobozJoan and Sanford I. Weill Department of Medicine, Weill Cornell Medical.
The University of Texas MD Anderson Cancer Center · USFlorida Cancer Specialists & Research Institute · USCenter for Cancers and Blood Disorders · USCleveland Clinic · USColorado Blood Cancer Institute · USCornell University · USFort Wayne Medical Institute · USHenry Ford Hospital · USMEI Pharma (United States) · USMoffitt Cancer Center · USOncology Hematology Care · USSarah Cannon · USSidney Kimmel Comprehensive Cancer Center · USSouthern Research Institute · USSouth Texas Veterans Health Care System · USTennessee Oncology · US

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

backgroundThe prognosis of patients with higher-risk myelodysplastic syndromes (MDS) remains poor despite available therapies. Histone deacetylase inhibitors have demonstrated activity in patients with MDS and in vitro synergy with azacitidine.

methodsA phase 2 randomized, placebo-controlled clinical trial of azacitidine and pracinostat was conducted in patients who had International Prognostic Scoring System intermediate-2-risk or high-risk MDS. The primary endpoint was the complete response (CR) rate by cycle 6 of therapy.

resultsOf 102 randomized patients, there were 51 in the pracinostat group and 51 in the placebo group. The median age was 69 years. The CR rate by cycle 6 of therapy was 18% and 33% (P = .07) in the pracinostat and placebo groups, respectively. No significant differences in overall survival (median, 16 vs 19 months, respectively; hazard ratio, 1.21; 95% confidence interval, 0.66-2.23) or progression-free survival (11 vs 9 months, respectively; hazard ratio, 0.82; 95% confidence interval, 0.546-1.46) were observed between groups. Grade ≥3 adverse events occurred more frequently in the pracinostat group (98% vs 74%), leading to more treatment discontinuations (20% vs 10%).

conclusionsThe combination of azacitidine with pracinostat did not improve outcomes in patients with higher-risk MDS. Higher rates of treatment discontinuation may partially explain these results, suggesting alternative dosing and schedules to improve tolerability may be required to determine the potential of the combination. Cancer 2017;123:994-1002. © 2016 American Cancer Society.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsAzacitidineBenzimidazolesBiomarkersDisease ProgressionFemaleHumansKaplan-Meier EstimateMaleMiddle AgedMyelodysplastic SyndromesPrognosisTreatment OutcomeAzacitidineBenzimidazolesBiomarkersSB939 compoundazacitidine combinationsclinical trialhistone deacetylasemyelodysplastic syndromes

Identifiers

PMID28094841
PMCPMC5432122
OpenAlexW2574794018

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.