Evidence map›Paper›PMID 21270442›Full record

Trial reportBlood2011

Results from a randomized trial of salvage chemotherapy followed by lestaurtinib for patients with FLT3 mutant AML in first relapse.

Mark Levis, Farhad Ravandi, Eunice S Wang, Maria R Baer, Alexander Perl, Steven Coutre, Harry Erba, Robert K Stuart, Michele Baccarani, Larry D Cripe and 22 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Blood, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00079482 (A Randomized, Open-Label Study of Oral CEP-701 Administered in Sequence With Standard Chemotherapy to Patients With Relapsed Acute Myeloid Leukemia), which is not on this map. Cited by 197 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
197citing papers in PubMed, 4 pooled it
24.3field-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.

NCT00079482 phase2completednot on this map

A Randomized, Open-Label Study of Oral CEP-701 Administered in Sequence With Standard Chemotherapy to Patients With Relapsed Acute Myeloid Leukemia (AML) Expressing FLT-3 Activating Mutations

TypeinterventionalSponsorCephalonRan2003 to 2010Enrolled224ConditionsAcute Myeloid LeukemiaArmsCEP-701, high-dose cytarabine, Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)
3 · Its place in the literature

Who cites it

197 citing papers in PubMed, 4 syntheses or guidelines pooled it, 397 citations in OpenAlex.

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  10. FDA Approval Summary: Gilteritinib for Relapsed or Refractory Acute Myeloid Leukemia with aClinical cancer research : an official journal of the American Association for Cancer Research · 2021
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137 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

32 authors at 20 institutions in 8 countries.

Mark LevisDepartment of Oncology, Johns Hopkins University, Baltimore, MD, USA. levisma@jhmi.edu
Farhad Ravandi
Eunice S Wang
Maria R Baer
Alexander Perl
Steven Coutre
Harry Erba
Robert K Stuart
Michele Baccarani
Larry D Cripe
Martin S Tallman
Giovanna Meloni
Lucy A Godley
Amelia A Langston
Sergio Amadori
Ian D Lewis
Arnon Nagler
Richard Stone
Karen Yee
Anjali Advani
Dan Douer
W Wiktor-Jedrzejczak
Gunnar Juliusson
Mark R Litzow
Stephen Petersdorf
Miguel Sanz
Hagop M Kantarjian
Takashi Sato
Lothar Tremmel
Debra M Bensen-Kennedy
Donald Small
B Douglas Smith
Johns Hopkins University · USThe University of Texas MD Anderson Cancer Center · USCleveland Clinic · USDana-Farber Cancer Institute · USEmory University · USHospital Universitari i Politècnic La Fe · ESIndiana University Health · USIstituto Oncologico Romagnolo · ITLund University · SEMayo Clinic in Arizona · USMedical University of South Carolina · USMedical University of Warsaw · PLMichigan Center for Translational Pathology · USNorthwestern University · USPrincess Margaret Hospital · NZRoswell Park Comprehensive Cancer Center · USSapienza University of Rome · ITSeattle Cancer Care Alliance · USSheba Medical Center · ILSouth Australia Pathology · AU

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
University of Texas M.D. Anderson Cancer SPORE-LeukemiaP50CA100632 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI KONOPLEVA, MARINA Y · 2003 to 2023
$43.7M
FLT3 Tyrosine Kinase Inhibitors As Therapy for LeukemiaR01CA090668 · NCI · JOHNS HOPKINS UNIVERSITY · PI SMALL, DONALD · 2002 to 2018
$5.0M
Incorporating FLT3 inhibitors into AML treatment regimensR01CA128864 · NCI · JOHNS HOPKINS UNIVERSITY · PI LEVIS, MARK J · 2008 to 2012
$1.7M
NCI NIH HHS P50 CA100632NCI NIH HHS P50 CA100632-06NCI NIH HHS R01 CA090668NCI NIH HHS R01 CA128864
6 · The paper itself

Abstract

In a randomized trial of therapy for FMS-like tyrosine kinase-3 (FLT3) mutant acute myeloid leukemia in first relapse, 224 patients received chemotherapy alone or followed by 80 mg of the FLT3 inhibitor lestaurtinib twice daily. Endpoints included complete remission or complete remission with incomplete platelet recovery (CR/CRp), overall survival, safety, and tolerability. Correlative studies included pharmacokinetics and analysis of in vivo FLT3 inhibition. There were 29 patients with CR/CRp in the lestaurtinib arm and 23 in the control arm (26% vs 21%; P = .35), and no difference in overall survival between the 2 arms. There was evidence of toxicity in the lestaurtinib-treated patients, particularly those with plasma levels in excess of 20 μM. In the lestaurtinib arm, FLT3 inhibition was highly correlated with remission rate, but target inhibition on day 15 was achieved in only 58% of patients receiving lestaurtinib. Given that such a small proportion of patients on this trial achieved sustained FLT3 inhibition in vivo, any conclusions regarding the efficacy of combining FLT3 inhibition with chemotherapy are limited. Overall, lestaurtinib treatment after chemotherapy did not increase response rates or prolong survival of patients with FLT3 mutant acute myeloid leukemia in first relapse. This study is registered at www.clinicaltrials.gov as #NCT00079482.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarbazolesChemotherapy, AdjuvantFemalefms-Like Tyrosine Kinase 3FuransHumansLeukemia, Myeloid, AcuteMaleMiddle AgedMutant ProteinsProtein Kinase InhibitorsRecurrenceRemission InductionCarbazolesFLT3 protein, humanfms-Like Tyrosine Kinase 3FuranslestaurtinibMutant ProteinsProtein Kinase Inhibitors

Identifiers

PMID21270442
PMCPMC3069671
OpenAlexW2016883830

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.