Evidence map›Paper›PMID 37935977›Full record

Trial reportLeukemia2024

A randomized phase III study of standard versus high-dose cytarabine with or without vorinostat for AML.

Guillermo Garcia-Manero, Nikolai A Podoltsev, Megan Othus, John M Pagel, Jerald P Radich, Min Fang, David A Rizzieri, Guido Marcucci, Stephen A Strickland, Mark R Litzow and 16 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in Leukemia, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01802333 (A Randomized Phase III Study of Standard Cytarabine Plus Daunorubicin), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
9.3field-weighted citation impact, top 2% 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.

NCT01802333 phase3completednot on this map

A Randomized Phase III Study of Standard Cytarabine Plus Daunorubicin (7+3) Therapy or Idarubicin With High Dose Cytarabine (IA) Versus IA With Vorinostat (NSC-701852) (IA + V) in Younger Patients With Previously Untreated Acute Myeloid Leukemia (AML)

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2013 to 2017Enrolled754ConditionsAcute Myeloid Leukemia, Untreated Adult Acute Myeloid LeukemiaArmsAllogeneic Hematopoietic Stem Cell Transplantation, Cytarabine, Daunorubicin Hydrochloride, Idarubicin, Laboratory Biomarker Analysis
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.

  1. Pooled it
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  11. Getting the right combination to break the epigenetic code.Nature reviews. Clinical oncology · 2025
    Review
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  14. Epigenetics-targeted drugs: current paradigms and future challenges.Signal transduction and targeted therapy · 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

26 authors at 19 institutions in 1 country.

Guillermo Garcia-Manero *Department of Leukemia, MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-3631-2482
Nikolai A Podoltsev *Yale School of Medicine, New Haven, CT, USA. nikolai.podoltsev@yale.edu.ORCID 0000-0002-3657-778X
Megan OthusSWOG Statistics and Data Management Center, Seattle, WA, USA.ORCID 0000-0001-8176-6371
John M PagelSwedish Cancer Institute, Seattle, WA, USA.ORCID 0000-0001-5745-8125
Jerald P RadichFred Hutchinson Cancer Center, Seattle, WA, USA.
Min FangFred Hutchinson Cancer Center, Seattle, WA, USA.
David A RizzieriDuke University Medical Center, Durham, NC, USA.ORCID 0000-0001-9886-5771
Guido MarcucciOhio State University (Alliance), Columbus, OH, USA.ORCID 0000-0002-3983-5908
Stephen A StricklandVanderbilt-Ingram Cancer Center, Nashville, TN, USA.ORCID 0000-0002-6861-2041
Mark R LitzowMayo Clinic, Rochester, MN, USA.ORCID 0000-0002-9816-6302
M Lynn SavoieTom Baker Cancer Centre, Calgary, AB, Canada.
Bruno C MedeirosStanford University, Stanford, CA, USA.
Mikkael A SekeresCleveland Clinic, Cleveland, OH, USA.ORCID 0000-0003-2009-6524
Tara L LinUniversity of Kansas Medical Center, Kansas City, KS, USA.ORCID 0000-0002-0242-6449
Geoffrey L UyWashington University School of Medicine, St. Louis, USA.ORCID 0000-0002-7809-0996
Bayard L PowellWake Forest Baptist Comprehensive Cancer Center, Winston-Salem, NC, USA.
Jonathan E KolitzNorth Shore University Hospital, Manhasset, NY, USA.
Richard A LarsonUniversity of Chicago, Chicago, IL, USA.
Richard M StoneDana Farber Cancer Institute, Boston, MA, USA.
David ClaxtonPennsylvania State Milton S Hershey Medical Center, Hummelstown, USA.ORCID 0000-0001-9209-2405
James EssellJewish Hospital, Cincinnati, OH, USA.
Selina M LugerUniversity of Pennsylvania Abramson Cancer Center, Philadelphia, PA, USA.
Sanjay R MohanVanderbilt-Ingram Cancer Center, Nashville, TN, USA.
Anna MoseleySWOG Statistics and Data Management Center, Seattle, WA, USA.ORCID 0000-0002-7514-7360
Frederick R AppelbaumFred Hutchinson Cancer Center, Seattle, WA, USA.
Harry P ErbaDuke University Cancer Center, Durham, NC, USA.
Fred Hutch Cancer Center · USVanderbilt University · USAtrium Health Wake Forest Baptist · USCity of Hope · USCleveland Clinic · USDana-Farber Cancer Institute · USDuke Medical Center · USDuke University · USJewish Hospital · USMayo Clinic in Arizona · USNorth Shore University Hospital · USPenn State Milton S. Hershey Medical Center · USStanford University · USThe University of Texas MD Anderson Cancer Center · USUniversity of Illinois Chicago · USUniversity of Kansas Medical Center · USUniversity of Pennsylvania · USWashington University in St. Louis · USYale University · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$167.6M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Catherine M. Tangen · 2014 to 2026
$115.2M
Heartland Cancer Research NCORPUG1CA189830 · NCI · DECATUR MEMORIAL HOSPITAL · PI Bryan A. Faller · 2014 to 2026
$40.9M
NCIC Clinical Trials Group - Canadian Collaborating Clinical Trials NetworkU10CA180863 · NCI · QUEEN'S UNIVERSITY AT KINGSTON · PI Janet Ellen Dancey · 2014 to 2026
$40.4M
Southeast Clinical Oncology Research Consortium, Inc. (SCOR)UG1CA189858 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI Judith O Hopkins, William J Irvin · 2014 to 2026
$38.8M
Michigan Cancer Research Consortium NCORPUG1CA189971 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI Tareq Al baghdadi · 2014 to 2026
$36.6M
Cancer Research Consortium of West Michigan (CRCWM)UG1CA189860 · NCI · COREWELL HEALTH · PI KATHLEEN YOST BUTLER · 2014 to 2026
$29.1M
The Pacific Cancer Research Consortium (PCRC), an NCORP Community SiteUG1CA189953 · NCI · SWEDISH MEDICAL CENTER, FIRST HILL · PI Alison Katherine Conlin, Charles Drescher · 2014 to 2026
$27.4M
UPSTATE CAROLINA COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035119 · NCI · SPARTANBURG REGIONAL MEDICAL CENTER · PI BEARDEN, JAMES D · 1985 to 2013
$21.5M
NCI NIH HHS CA13612NCI NIH HHS CA58723NCI NIH HHS L30 CA110834NCI NIH HHS N01 CA004919NCI NIH HHS N01 CA013612NCI NIH HHS N01 CA035119NCI NIH HHS P30 CA016672NCI NIH HHS R01 CA049195NCI NIH HHS R01 CA126447NCI NIH HHS U10 CA004919NCI NIH HHS U10 CA011083NCI NIH HHS U10 CA012644NCI NIH HHS U10 CA013612NCI NIH HHS U10 CA016385NCI NIH HHS U10 CA035119NCI NIH HHS U10 CA046113NCI NIH HHS U10 CA046282NCI NIH HHS U10 CA046368NCI NIH HHS U10 CA073590NCI NIH HHS U10 CA077202NCI NIH HHS U10 CA180798NCI NIH HHS U10 CA180801NCI NIH HHS U10 CA180816NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180826NCI NIH HHS U10 CA180835NCI NIH HHS U10 CA180846NCI NIH HHS U10 CA180855NCI NIH HHS U10 CA180858NCI NIH HHS U10 CA180863NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA189822NCI NIH HHS UG1 CA189830NCI NIH HHS UG1 CA189848NCI NIH HHS UG1 CA189853NCI NIH HHS UG1 CA189856NCI NIH HHS UG1 CA189858NCI NIH HHS UG1 CA189860NCI NIH HHS UG1 CA189872NCI NIH HHS UG1 CA189953NCI NIH HHS UG1 CA189957NCI NIH HHS UG1 CA189971NCI NIH HHS UG1 CA233270NCI NIH HHS UG1 CA233331NIDA NIH HHS F31 DA046136
6 · The paper itself

Abstract

Prior experience indicated that use of higher doses of cytarabine during induction for acute myeloid leukemia (AML) with a histone deacetylase inhibitor resulted in high response rates. S1203 was a randomized multicenter trial for previously untreated patients aged 18-60 with AML which compared daunorubicin and cytarabine (DA), idarubicin with higher dose cytarabine (IA) and IA with vorinostat (IA + V). The primary endpoint was event free survival (EFS). 738 patients were randomized: 261 to each DA and IA arms and 216 to the IA + V arm. 96, 456, and 150 patients had favorable-, intermediate-, and unfavorable-risk cytogenetics, respectively. 152 were NPM1 and 158 FLT3 mutated. The overall remission rate was 77.5% including 62.5% CR and 15.0% CRi. No differences in remission, EFS, or overall survival were observed among the 3 arms except for the favorable cytogenetics subset who had improved outcomes with DA and postremission high dose cytarabine. A trend towards increased toxicity was observed with the IA and IA + V arms. The use of higher dose cytarabine during induction therapy in younger patients with AML, with or without vorinostat, does not result in improved outcomes. (Funded by the US National Institutes of Health and others, ClinicalTrials.gov number, NCT01802333.).

Indexed as

CytarabineLeukemia, Myeloid, AcuteAntineoplastic Combined Chemotherapy ProtocolsDaunorubicinHumansIdarubicinRemission InductionVorinostatCytarabineDaunorubicinIdarubicinVorinostat

Identifiers

PMID37935977
PMCPMC11729399
OpenAlexW4388455931

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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.