アブストラクト | AIMS: Therapeutic 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(R) individual case safety report database, the aim was to establish the association between anticancer drugs and CTRCD reporting. METHODS AND RESULTS: This study was a disproportionality analysis conducted in VigiBase(R) from the initial report of any anticancer drug until February 29, 2024. Reporting odds ratios for CTRCD were evaluated using a stepwise selection procedure and multivariable-adjusted analyses. Subsequently, secondary analyses consisted of the decription 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 (8,833 CTRCD cases). Primary analysis revealed 25 anticancer drugs significantly associated with CTRCD reporting, with trastuzumab, doxorubicin, and bortezomib exhibiting the strongest associations. CTRCD 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. CONCLUSION: This disproportionality study identified 25 anticancer drugs significantly associated with CTRCD reporting, including new signals. It highlights discrepancies compared to 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. |
ジャーナル名 | European heart journal. Cardiovascular pharmacotherapy |
Pubmed追加日 | 2025/4/24 |
投稿者 | Legallois, Damien; Da Silva, Angelique; Alexandre, Joachim; Milliez, Paul; Sabatier, Remi; Blanchart, Katrien; Plane, Anne-Flore; Font, Jonaz; ChreTien, Basile; Dolladille, Charles |
組織名 | Normandie Univ, UNICAEN, INSERM U1086 ANTICIPE, Avenue de la Cote de Nacre,;F-14000 CAEN, France; Caen-Normandy University Hospital, PICARO Cardio-Oncology;Program, Department of Cardiology, Avenue de la Cote de Nacre, F-14000 CAEN,;France.;Program, Departments of Pharmacology and Medical Oncology, Avenue de la Cote de;Nacre, F-14000 CAEN, France.;Program, Department of Pharmacology, Avenue de la Cote de Nacre, F-14000 CAEN,;Normandie Univ, UNICAEN, INSERM U1237 PhIND, GIP Cyceron, Boulevard Henri;Becquerel, F-14000 CAEN, France; Caen-Normandy University Hospital, Department of;Cardiology, Avenue de la Cote de Nacre, F-14000 CAEN, France.;Caen-Normandy University Hospital, Department of Cardiology, Avenue de la Cote de;F-14000 CAEN, France; Caen-Normandy University Hospital, Department of;Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan. |
Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40272201/ |