Evidence map›Paper›PMID 41729312›Full record

SynthesisClinical and experimental medicine2026

Safety profile of FLT3 inhibitors in acute myeloid leukemia: a systematic review and meta-analysis of adverse events.

Mario Gaio, Alessia Zinzi, Valerio Liguori, Cecilia Cagnotta, Mario Frasca, Ludovica Vittoria Laino, Francesco Rossi, Annalisa Capuano

Abstract readSystematic ReviewMeta-Analysis
In one paragraph

Synthesis in Clinical and experimental medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Review
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

8 authors.

Mario GaioDepartment of Life Science, Health, and Health Professions, Link Campus University, Rome, Italy.
Alessia ZinziDepartment of Life Science, Health, and Health Professions, Link Campus University, Rome, Italy.
Valerio LiguoriCampania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Naples, Italy.
Cecilia CagnottaCampania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Naples, Italy. cecilia.cagnotta@unicampania.it.
Mario FrascaCampania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Naples, Italy.
Ludovica Vittoria LainoCampania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Naples, Italy.
Francesco RossiDepartment of Life Science, Health, and Health Professions, Link Campus University, Rome, Italy.
Annalisa CapuanoCampania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Naples, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Acute myeloid leukemia (AML) is the most common acute leukemia in adults. Approximately 30% of patients present alterations in the FMS-like receptor tyrosine kinase 3 (FLT3) gene, which are associated with poor prognosis. FLT3 inhibitors - midostaurin (first-generation), gilteritinib and quizartinib (second-generation) - have been developed to block FLT3 activation. Given the need of optimizing treatment in FLT3-mutated AML, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to compare the safety profiles of FLT3 inhibitors. Following the PRISMA statement, we searched Embase, MEDLINE and Cochrane Library. The Cochrane Risk of Bias Tool for RCTs was used for quality assessment. Of 2132 references, seven RCTs, involving 2409 adult patients, met inclusion criteria: quizartinib and midostaurin in two trials each and gilteritinib in three. The most frequently reported adverse events (AEs) were classified under the System Organ Class (SOC) Blood and lymphatic system disorders (N = 5474, 58.4% of them related to FLT3 inhibitors). The most frequently observed non-hematological AEs were gastrointestinal disorders, pyrexia, elevated ALT/AST and headache. FLT3 inhibitors are not associated with a significant increase in the risk of AEs compared to standard treatments. No meaningful differences in AE risk were observed among the three drugs. The only exception was an higher risk of ALT increased with gilteritinib (RR = 2.40, 95% CI: 1.16-4.95). Future studies should stratify safety outcomes by demographic and clinical characteristics and incorporate long-term follow-up for a more comprehensive safety assessment in clinical practice.

Indexed as

Antineoplastic Agentsfms-Like Tyrosine Kinase 3Leukemia, Myeloid, AcuteProtein Kinase InhibitorsAniline CompoundsBenzothiazolesHumansPhenylurea CompoundsPyrazinesRandomized Controlled Trials as TopicStaurosporineAniline CompoundsAntineoplastic AgentsBenzothiazolesFLT3 protein, humanfms-Like Tyrosine Kinase 3gilteritinibmidostaurinPhenylurea CompoundsProtein Kinase InhibitorsPyrazinesquizartinibStaurosporineAcute myeloid leukemiaFLT3 inhibitorsGilteritinibMidostaurinQuizartinibSafety

Identifiers

PMID41729312
PMCPMC12953341

What OpenQuestion holds

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Registered trials

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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.