Evidence map›Paper›PMID 31060979›Full record

Trial reportThe Lancet. Haematology2019

Guadecitabine (SGI-110) in patients with intermediate or high-risk myelodysplastic syndromes: phase 2 results from a multicentre, open-label, randomised, phase 1/2 trial.

Guillermo Garcia-Manero, Gail Roboz, Katherine Walsh, Hagop Kantarjian, Ellen Ritchie, Patricia Kropf, Casey O'Connell, Raoul Tibes, Scott Lunin, Todd Rosenblat and 12 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Haematology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed
–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

44 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Epigenetic Targeting in Myeloid Malignancies.Advances in experimental medicine and biology · 2026
    Review
  5. Review
  6. Review
  7. Article
  8. Review
  9. Epigenetics-targeted drugs: current paradigms and future challenges.Signal transduction and targeted therapy · 2024
    Review
  10. Review
  11. Review
  12. Article
  13. Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Article
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors.

Guillermo Garcia-ManeroThe University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: ggarciam@mdanderson.org.
Gail RobozNew York-Presbyterian/Weill Cornell Medical Center, New York, NY, USA.
Katherine WalshThe Ohio State University, Columbus, OH, USA.
Hagop KantarjianThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Ellen RitchieNew York-Presbyterian/Weill Cornell Medical Center, New York, NY, USA.
Patricia KropfFox Chase Cancer Center, Philadelphia, PA, USA.
Casey O'ConnellKeck School of Medicine of University of Southern California, Los Angeles, CA, USA.
Raoul TibesMayo Clinic, Scottsdale, AZ, USA.
Scott LuninFort Myers Cancer Center, Fort Myers, FL, USA.
Todd RosenblatColumbia University Irving Medical Center, New York, NY, USA.
Karen YeePrincess Margaret Cancer Centre, Toronto, ON, Canada.
Wendy StockThe University of Chicago Medicine Comprehensive Cancer Center, Chicago, IL, USA.
Elizabeth GriffithsRoswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
Joseph MaceFlorida Cancer Specialists & Research Institute, St Petersburg, FL, USA.
Nikolai PodoltsevYale School of Medicine, New Haven, CT, USA.
Jesus BerdejaSarah Cannon Cancer Center, Nashville, TN, USA.
Elias JabbourThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jean-Pierre J IssaFels Institute for Cancer Research & Molecular Biology, Temple University, Philadelphia, PA, USA.
Yong HaoAstex Pharmaceuticals, Pleasanton, CA, USA.
Harold N KeerAstex Pharmaceuticals, Pleasanton, CA, USA.
Mohammad AzabAstex Pharmaceuticals, Pleasanton, CA, USA.
Michael R SavonaVanderbilt-Ingram Cancer Center, Vanderbilt University School of Medicine, Nashville, TN, USA.

Funding

USC/NORRIS COMPREHENSIVE CANCER CENTER (CORE) SUPPORTP30CA014089 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI MYLES G COCKBURN · 1985 to 2026
$181.4M
NCI NIH HHS P30 CA014089
6 · The paper itself

Abstract

backgroundGuadecitabine is a next-generation hypomethylating agent whose active metabolite decitabine has a longer in-vivo exposure time than intravenous decitabine. More effective hypomethylating agents are needed for the treatment of myelodysplastic syndromes. In the present study, we aimed to compare the activity and safety of two doses of guadecitabine in hypomethylating agent treatment-naive or relapsed or refractory patients with intermediate-risk or high-risk myelodysplastic syndromes.

methodsThis phase 2 part of the phase 1/2, randomised, open-label study enrolled patients aged 18 years or older from 14 North American medical centres with International Prognostic Scoring System intermediate-1-risk, intermediate-2-risk, or high-risk myelodysplastic syndromes, or chronic myelomonocytic leukaemia. They were either hypomethylating agent treatment-naive or had relapsed or refractory disease after previous hypomethylating agent treatment as determined by the investigators' judgment. Eligible patients had Eastern Cooperative Oncology Group performance status of 0-2. Patients were randomly assigned (1:1) using a computer algorithm for dynamic randomisation to subcutaneous guadecitabine 60 or 90 mg/m

findingsBetween July 9, 2012, and April 7, 2014, 105 patients were enrolled: 55 (52%) were allocated to guadecitabine 60 mg/m

interpretationGuadecitabine was clinically active with acceptable tolerability in patients with intermediate-risk and high-risk myelodysplastic syndromes. Responses and overall survival in the relapsed or refractory cohort offer the potential of a new therapeutic option for patients for whom currently available hypomethylating agents are not successful. We therefore recommend guadecitabine at a dose of 60 mg/m

fundingAstex Pharmaceuticals and Stand Up To Cancer.

Indexed as

AdolescentAdultAgedAged, 80 and overAntineoplastic AgentsAzacitidineDose-Response Relationship, DrugFemaleHumansMaleMiddle AgedMyelodysplastic SyndromesNeutropeniaSeverity of Illness IndexSurvival RateThrombocytopeniaAntineoplastic AgentsAzacitidineguadecitabine

Identifiers

PMID31060979
PMCPMC9012213

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.