Evidence map›Paper›PMID 38231126›Full record

Trial reportBlood advances2024

Guadecitabine vs TC in relapsed/refractory AML after intensive chemotherapy: a randomized phase 3 ASTRAL-2 trial.

Gail J Roboz, Guillermo Sanz, Elizabeth A Griffiths, Karen Yee, Hagop Kantarjian, Christian Récher, Michael T Byrne, Elżbieta Patkowska, Hee-Je Kim, Xavier Thomas and 11 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Blood advances, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02920008 (A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
4.1field-weighted citation impact, top 6% 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.

NCT02920008 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) Versus Treatment Choice in Adults With Previously Treated Acute Myeloid Leukemia

TypeinterventionalSponsorAstex Pharmaceuticals, Inc.Ran2017 to 2020Enrolled302ConditionsAcute Myeloid LeukemiaArmsguadecitabine, Treatment Choice (TC)
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Review
  5. Epigenetic Targeting in Myeloid Malignancies.Advances in experimental medicine and biology · 2026
    Review
  6. Article
  7. Epigenetics-targeted drugs: current paradigms and future challenges.Signal transduction and targeted therapy · 2024
    Review
  8. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 19 institutions in 10 countries.

Gail J RobozDepartment of Medicine, Division of Hematology and Medical Oncology, Weill Cornell Medicine and the New York-Presbyterian Hospital, New York, NY.ORCID 0000-0002-0384-3658
Guillermo SanzHospital Universitari i Politècnic La Fe, Instituto de Investigación Sanitaria La Fe,Valencia, and CIBERONC Cáncer, Instituto de Salud Carlos III, Madrid, Spain.ORCID 0000-0002-2767-8191
Elizabeth A GriffithsDepartment of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY.ORCID 0000-0002-0288-8248
Karen YeeDepartment of Medicine, Princess Margaret Cancer Centre, Toronto, ON, Canada.ORCID 0000-0002-2572-9952
Hagop KantarjianDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.
Christian RécherInstitut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, France.
Michael T ByrneDepartment of Medicine, Vanderbilt University Medical Center, Nashville, TN.
Elżbieta PatkowskaInstitute of Hematology and Transfusion Medicine, Warsaw, Poland.
Hee-Je KimCatholic Hematology Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.ORCID 0000-0003-4098-3366
Xavier ThomasHôpital Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite, France.
Ine MoorsDepartment of Hematology, Universitair Ziekenhuis Gent, Ghent, Belgium.
Wendy StockDepartment of Medicine, The University of Chicago Medical Center, Chicago, IL.
Árpád IllésFaculty of Medicine, University of Debrecen, Debrecen, Hungary.
Pierre FenauxHôpital Saint-Louis, Assistance Publique Hôpitaux de Paris and Université Paris Cité, Paris, France.
Yasushi MiyazakiDepartment of Hematology, Nagasaki University Hospital, Nagasaki, Japan.
Takahiro YamauchiDepartment of Hematology, University of Fukui Hospital, Eiheiji-chō, Japan.
Casey L O'ConnellKeck School of Medicine of USC, Los Angeles, CA.
Yong HaoAstex Pharmaceuticals, Inc, Pleasanton, CA.
Harold N KeerAstex Pharmaceuticals, Inc, Pleasanton, CA.
Mohammad AzabAstex Pharmaceuticals, Inc, Pleasanton, CA.
Hartmut DöhnerDepartment of Internal Medicine, Ulm University Hospital, Ulm, Germany.ORCID 0000-0003-2116-5536
Plex Pharmaceuticals (United States) · USGhent University Hospital · BEHospices Civils de Lyon · FRInstituto de Salud Carlos III · ESInstitut universitaire du cancer de Toulouse Oncopole · FRInstytut Hematologii i Transfuzjologi · PLNagasaki University Hospital · JPNewYork–Presbyterian Hospital · USPrincess Margaret Cancer Centre · CARoswell Park Comprehensive Cancer Center · USThe Catholic University of Korea Seoul St. Mary's Hospital · KRThe University of Texas MD Anderson Cancer Center · USUniversité Paris Cité · FRUniversity Hospital Ulm · DEUniversity of Chicago Medical Center · USUniversity of Debrecen · HUUniversity of Fukui Hospital · JPUniversity of Southern California · USVanderbilt University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

abstractGuadecitabine is a novel hypomethylating agent (HMA) resistant to deamination by cytidine deaminase. Patients with relapsed/refractory acute myeloid leukemia (AML) were randomly assigned to guadecitabine or a preselected treatment choice (TC) of high-intensity chemotherapy, low-intensity treatment with HMAs or low-dose cytarabine, or best supportive care (BSC). The primary end point was overall survival (OS). A total of 302 patients were randomly assigned to guadecitabine (n = 148) or TC (n = 154). Preselected TCs were low-intensity treatment (n = 233 [77%; mainly HMAs]), high-intensity chemotherapy (n = 63 [21%]), and BSC (n = 6 [2%]). The median OS were 6.4 and 5.4 months for guadecitabine and TC, respectively (hazard ratio 0.88 [95% confidence interval, 0.67-1.14]; log-rank P = .33). Survival benefit for guadecitabine was suggested in several prospective subgroups, including age <65 years, Eastern Cooperative Oncology Group performance status 0 to 1, refractory AML, and lower peripheral blood blasts ≤30%. Complete response (CR) + CR with partial hematologic recovery rates were 17% for guadecitabine vs 8% for TC (P < .01); CR+CR with incomplete count recovery rates were 27% for guadecitabine vs 14% for TC (P < .01). Safety was comparable for the 2 arms, but guadecitabine had a higher rate of grade ≥3 neutropenia (32% vs 17%; P < .01). This study did not demonstrate an OS benefit for guadecitabine. Clinical response rates were higher for guadecitabine, with comparable safety to TC. There was an OS benefit for guadecitabine in several prespecified subgroups. This study was registered at www.clinicaltrials.gov as #NCT02920008.

Indexed as

AzacitidineLeukemia, Myeloid, AcuteAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCytarabineDrug Resistance, NeoplasmFemaleHumansMaleMiddle AgedRecurrenceTreatment OutcomeYoung AdultAzacitidineCytarabineguadecitabine

Identifiers

PMID38231126
PMCPMC11103175
OpenAlexW4390942391

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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.