Evidence map›Paper›PMID 40272201›Full record

ArticleEuropean heart journal. Cardiovascular pharmacotherapy2025

Identification of anticancer drugs associated to cancer therapy-related cardiac dysfunction: a VigiBase® disproportionality analysis.

Damien Legallois, Angélique Da Silva, Joachim Alexandre, Paul Milliez, Rémi Sabatier, Katrien Blanchart, Anne-Flore Plane, Jonaz Font, Basile Chrétien, Charles Dolladille

Registry-linked trialAbstract read
In one paragraph

Article in European heart journal. Cardiovascular pharmacotherapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06268535 (Identification of Anticancer Drugs Associated With Cancer Therapy-related Cardiac Dysfunction), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT06268535 completednot on this map

Identification of Anticancer Drugs Associated With Cancer Therapy-related Cardiac Dysfunction: a WHO Pharmacovigilance Database

TypeobservationalSponsorUniversity Hospital, CaenRan2022 to 2024Enrolled36,580,288ConditionsHeart Failure, Cancer, Therapy-RelatedArmsCancer therapy with FDA and/or European Medicines Agency approval on the 30th September 2023
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
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

10 authors.

Damien LegalloisNormandie Univ, UNICAEN, INSERM U1086 ANTICIPE, Avenue de la Côte de Nacre, F-14000 Caen, France.ORCID 0000-0002-2297-4418
Angélique Da SilvaNormandie Univ, UNICAEN, INSERM U1086 ANTICIPE, Avenue de la Côte de Nacre, F-14000 Caen, France.
Joachim AlexandreNormandie Univ, UNICAEN, INSERM U1086 ANTICIPE, Avenue de la Côte de Nacre, F-14000 Caen, France.
Paul MilliezNormandie Univ, UNICAEN, INSERM U1237 PhIND, GIP Cyceron, Boulevard Henri Becquerel, F-14000 Caen, France.
Rémi SabatierDepartment of Cardiology, Caen-Normandy University Hospital, Avenue de la Côte de Nacre, F-14000 Caen, France.
Katrien BlanchartDepartment of Cardiology, Caen-Normandy University Hospital, Avenue de la Côte de Nacre, F-14000 Caen, France.
Anne-Flore PlaneDepartment of Cardiology, Caen-Normandy University Hospital, PICARO Cardio-Oncology Program, Avenue de la Côte de Nacre, F-14000 Caen, France.
Jonaz FontNormandie Univ, UNICAEN, INSERM U1086 ANTICIPE, Avenue de la Côte de Nacre, F-14000 Caen, France.ORCID 0000-0002-3103-9739
Basile ChrétienDepartment of Advanced Medicine, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya 466-8560, Japan.
Charles DolladilleNormandie Univ, UNICAEN, INSERM U1086 ANTICIPE, Avenue de la Côte de Nacre, F-14000 Caen, France.ORCID 0000-0003-0449-6261

Funding

AVIESANCARNAVALFédération Hospitalo-UniversitaireGroupement de coopération sanitaire
6 · The paper itself

Abstract

aimsTherapeutic advancements have significantly enhanced cancer patient survival rates yet concomitantly increased the prevalence of associated toxicities, such as cancer therapy-related cardiac dysfunction (CTRCD), either symptomatic (heart failure) or not. Using the World Health Organization's VigiBase® individual case safety report database, the aim was to establish the association between anticancer drugs and CTRCD reporting. METHODS AND

resultsThis study was a disproportionality analysis conducted in VigiBase® from the initial report of any anticancer drug until 29 February 2024. Reporting odds ratios for CTRCD were evaluated using a stepwise selection procedure and multivariable-adjusted analyses. Subsequently, secondary analyses consisted of the description of CTRCD cases associated with the identified anticancer drugs. ClinicalTrials.gov registration number: NCT06268535. Among 36 580 288 database reports, 42 828 CTRCD cases associated with at least one anticancer drug were identified with death reported in 20.6% of cases (8833 CTRCD cases). Primary analysis revealed 25 anticancer drugs significantly associated with CTRCD reporting, with trastuzumab, doxorubicin, and bortezomib exhibiting the strongest associations. Cancer therapy-related cardiac dysfunction reporting was associated with kinase inhibitors, including BCR-ABL inhibitors, ibrutinib, and osimertinib. New signals were identified for trabectedin, clofarabine, fludarabine, entrectinib, gemtuzumab ozogamicin, and anagrelide. In contrast, immune checkpoint inhibitors and most anti-vascular endothelial growth factor therapies showed no association with CTRCD.

conclusionThis disproportionality study identified 25 anticancer drugs significantly associated with CTRCD reporting, including new signals. It highlights discrepancies compared with drugs recommended for cardiac dysfunction evaluation in the 2022 ESC Guidelines. This underscores the importance of including CTRCD as a safety endpoint in cancer studies.

Indexed as

Antineoplastic AgentsHeart DiseasesNeoplasmsAdverse Drug Reaction Reporting SystemsAgedCardiotoxicityDatabases, FactualFemaleHumansMaleMiddle AgedPharmacovigilanceRisk AssessmentRisk FactorsTime FactorsAntineoplastic Agentsanticancer drugscancer therapy-related cardiac dysfunctionHeart failurepharmacovigilance database

Identifiers

PMID40272201
PMCPMC12342995

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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.