Evidence map›Paper›PMID 30028037›Full record

Trial reportAmerican journal of hematology2018

Sorafenib Combined with 5-azacytidine in Older Patients with Untreated FLT3-ITD Mutated Acute Myeloid Leukemia.

Maro Ohanian, Guillermo Garcia-Manero, Mark Levis, Elias Jabbour, Naval Daver, Gautam Borthakur, Tapan Kadia, Sherry Pierce, Jan Burger, Mary Ann Richie and 6 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in American journal of hematology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 76 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
76citing papers in PubMed, 2 pooled it
7.2field-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.

NCT01254890 phase1 / phase2completednot on this map

Phase I/II Study of Sorafenib and 5-Azacitidine for the Treatment of Patients With Refractory or Relapsed Acute Leukemia and Myelodysplastic Syndrome (MDS) - (VZ-MDS-PI-0227)

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2011 to 2015Enrolled60ConditionsLeukemiaArmsAzacitidine, Sorafenib
NCT02196857 phase2completednot on this map

Phase II Study of Sorafenib Plus 5-Azacitidine for the Initial Therapy of Patients With Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome With FLT3-ITD Mutation

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2015 to 2018Enrolled16ConditionsLeukemiaArmsAzacytidine, Sorafenib
3 · Its place in the literature

Who cites it

76 citing papers in PubMed, 2 syntheses or guidelines pooled it, 116 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Azacitidine, Venetoclax, and Gilteritinib in Newly Diagnosed and Relapsed or RefractoryJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Trial
  4. Trial
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  6. Trial
  7. Review
  8. Long-term outcomes inHaematologica · 2026
    Article
  9. Review
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  11. Article
  12. Review
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  14. Review
  15. Article
  16. Article
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  18. Review
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  20. Article

16 more citing papers are in PubMed but not listed here.

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

16 authors at 2 institutions in 1 country.

Maro OhanianDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas.
Guillermo Garcia-ManeroDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas.
Mark LevisDivision of Hematological Malignancies, Johns Hopkins Sidney Kimmel Cancer Center, Baltimore, Maryland.
Elias JabbourDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas.
Naval DaverDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas.
Gautam BorthakurDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas.
Tapan KadiaDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas.
Sherry PierceDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas.
Jan BurgerDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas.
Mary Ann RichieDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas.
Keyur PatelDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas.
Michael AndreeffDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas.
Zeev EstrovDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas.
Jorge CortesDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas.
Hagop KantarjianDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas.
Farhad RavandiDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas.
The University of Texas MD Anderson Cancer Center · USSidney Kimmel Comprehensive Cancer Center · 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 CA016672Onyx/Bayer and Celgene
6 · The paper itself

Abstract

Based on our previous study of the combination of sorafenib with 5-azacytidine (AZA) in relapsed/refractory patients with FLT3 mutated acute myeloid leukemia (AML), we hypothesized that the combination would be efficacious and well tolerated in untreated patients with FLT3 mutated AML who are unsuitable for standard chemotherapy due to advanced age or lack of fitness. Newly diagnosed patients with untreated FLT3 mutated AML who underwent frontline therapy on 2 separate protocols of AZA plus sorafenib were analyzed. The clinical trials were registered at clinicaltrials.gov (NCT02196857 and NCT01254890). Overall, 27 patients with untreated FLT3 mutated AML (median age of 74 years, range, 61-86) were enrolled. The overall response rate was 78% (7 [26%] CR, 12 [44%] CRi/CRp, and 2 [7%] PR). Patients received a median of 3 treatment cycles (1-35). The median duration of CR/CRp/CRi is 14.5 months (1.1-28.7 months). Three (11%) responding patients (1 CR, 2 CRi) proceeded to allogeneic stem cell transplant. The median follow-up for surviving patients was 4.1 months (3.0-17.3 months). The median overall survival for the entire group was 8.3 months, and 9.2 months in the 19 responders. The regimen was well tolerated in elderly patients with untreated FLT3 mutated AML with no early deaths.

Indexed as

AgedAged, 80 and overAge FactorsAntineoplastic Combined Chemotherapy ProtocolsAzacitidinefms-Like Tyrosine Kinase 3HumansLeukemia, Myeloid, AcuteMiddle AgedMutationRemission InductionSalvage TherapySorafenibStem Cell TransplantationSurvival AnalysisTransplantation, HomologousAzacitidinefms-Like Tyrosine Kinase 3Sorafenib

Identifiers

PMID30028037
PMCPMC12422155
OpenAlexW2883443104

What OpenQuestion holds

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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.