| アブストラクト | Cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors are a recent targeted therapy approved for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer. Abemaciclib, palbociclib and ribociclib demonstrated great efficacy and safety during clinical studies. However, differences in their adverse-event profiles have been observed. This work aims to describe the suspected adverse drug reactions (ADRs), such as leukopenia and thrombocytopenia, reported for each CDK4/6 inhibitor in the EudraVigilance (EV) database. Data on individual case safety reports (ICSRs) were obtained by accessing the European spontaneous reporting system via the EV website. Information on concomitant drug therapy, including fulvestrant, letrozole, anastrozole and exemestane, was also analyzed. A total of 1611 ICSRs were collected from the EV database. Most reports of palbociclib and ribociclib were classified as serious cases for both suspected leukopenia and thrombocytopenia ADRs. However, most patients had their leukopenia and thrombocytopenia recovered/resolved. On the contrary, reports of abemaciclib were mostly characterized as non-serious cases. Abemaciclib and palbociclib were often combined with fulvestrant, while ribociclib was generally associated with letrozole. Pharmacovigilance studies are crucial for the early identification of potential ADRs and to better differentiate the toxicity profile of the different CDK4/6 inhibitors, particularly in a real-world setting. |
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| ジャーナル名 | Pharmaceuticals (Basel, Switzerland) |
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| 投稿日 | 2023/10/28 |
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| 投稿者 | Martins, Vera; Jesus, Mafalda; Pereira, Luisa; Monteiro, Cristina; Duarte, Ana Paula; Morgado, Manuel |
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| 組織名 | Health Sciences Faculty, University of Beira Interior (FCS-UBI), 6200-506;Covilha, Portugal.;Health Sciences Research Centre, University of Beira Interior (CICS-UBI),;6200-506 Covilha, Portugal.;CMA-UBI, Centre of Mathematics and Applications, University of Beira Interior,;Rua Marques d'Avila e Bolama, 6201-001 Covilha, Portugal.;UFBI-Pharmacovigilance Unit of Beira Interior, University of Beira Interior,;Pharmaceutical Services, University Hospital Center of Cova da Beira, 6200-251 |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37895811/ |
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