Evidence map›Paper›PMID 41372707›Full record

ArticleAnnals of hematology2025

Predicting the toxicity-efficacy ratio of venetoclax in real-world patients.

Loïc Osanno, Lucy Brocque, Laurent Bourguignon, Carla Delpech, Laure Farnault, Julien Colle, Pauline Roche, Jacques Chiaroni, Caroline Izard, Régis Costello and 7 more

Abstract read
In one paragraph

Article in Annals of hematology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

17 authors.

Loïc OsannoPharmacie hôpital la Conception, APHM, Marseille, France.
Lucy BrocquePharmacie hôpital la Conception, APHM, Marseille, France.
Laurent BourguignonService de Pharmacie, Hospices Civils de Lyon, Groupement Hospitalier Nord, Lyon, France. laurent.bourguignon@chu-lyon.fr.
Carla DelpechPharmacie hôpital la Conception, APHM, Marseille, France.
Laure FarnaultService d 'Hématologie et Thérapie Cellulaire, Centre Hospitalo- Universitaire de la Conception. Assistance Publique des Hôpitaux de Marseille, Marseille, France.
Julien ColleService d 'Hématologie et Thérapie Cellulaire, Centre Hospitalo- Universitaire de la Conception. Assistance Publique des Hôpitaux de Marseille, Marseille, France.
Pauline RocheService d 'Hématologie et Thérapie Cellulaire, Centre Hospitalo- Universitaire de la Conception. Assistance Publique des Hôpitaux de Marseille, Marseille, France.
Jacques ChiaroniEtablissement Français du Sang PACA Corse, Marseille, France.
Caroline IzardEtablissement Français du Sang PACA Corse, Marseille, France.
Régis CostelloService d 'Hématologie et Thérapie Cellulaire, Centre Hospitalo- Universitaire de la Conception. Assistance Publique des Hôpitaux de Marseille, Marseille, France.
Mathilde DacosPharmacie hôpital la Conception, APHM, Marseille, France.
Caroline SolasLaboratoire de Pharmacocinétique et Toxicologie, APHM, Hôpital La Timone, Unité des Virus Émergents (UVE: Aix-Marseille Univ-IRD 190-Inserm 1207), Marseille, France.
Chems DjezzarHospitalisation à Domicile, APHM, Hôpital de la Conception, Marseille, France.
Joseph CiccoliniCOMPO UMR Inserm 1068, CNRS UMR 7258, Aix Marseille Université, Marseille, France.
Thomas CluzeauDépartement d'hématologie, Université Cote, D'azur, CHU de Nice, Nice, France.
Geoffroy Venton *Service d 'Hématologie et Thérapie Cellulaire, Centre Hospitalo- Universitaire de la Conception. Assistance Publique des Hôpitaux de Marseille, Marseille, France.
Raphaëlle Fanciullino *Pharmacie hôpital la Conception, APHM, Marseille, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study investigates the pharmacokinetic variability and exposure-response relationships of Venetoclax (VEN) in adult patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. The study was conducted in a real-world clinical setting and included 48 patients who were treated with VEN in combination with azacytidine. We found significant inter-individual variability of 68% and intra-individual variability of 39% in plasma VEN concentrations. In addition, higher VEN concentrations were associated with better hematological responses. Median overall survival for the entire cohort was 17.8 months, with 1- and 2-year survival rates of 51% and 36.4%, respectively. A comparison of the 14-day VEN and 28-day VEN protocols showed that patients benefited from longer treatment durations, which resulted in more courses being administered. Plasma concentrations in the 14-day VEN protocol were higher than in the 28-day VEN protocol (2330 + 1675 ng/mL vs. 1503 + 966 ng/mL, respectively) without an increase in toxicities. The optimal protocol would be 400 mg/14d if we consider survival as a function of the 1818ng/mL cutoff. These results highlight the importance of considering therapeutic drug monitoring (TDM) as a strategy to optimize treatment outcomes by balancing efficacy and safety.

Indexed as

Bridged Bicyclo Compounds, HeterocyclicLeukemia, Myeloid, AcuteSulfonamidesAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansMaleMiddle AgedRetrospective StudiesSurvival RateTreatment OutcomeBridged Bicyclo Compounds, HeterocyclicSulfonamidesvenetoclaxAcute myeloid leukemiaHematological toxicityPharmacokinetic variabilityTherapeutic drug monitoringVenetoclax

Identifiers

PMID41372707
PMCPMC12764621

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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.