Hematological Events Potentially Associated with CDK4/6 Inhibitors: An Analysis from the European Spontaneous Adverse Event Reporting System
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 saf...
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| Format: | Article |
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MDPI AG
2023-09-01
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| Series: | Pharmaceuticals |
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| Online Access: | https://www.mdpi.com/1424-8247/16/10/1340 |
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| author | Vera Martins Mafalda Jesus Luísa Pereira Cristina Monteiro Ana Paula Duarte Manuel Morgado |
| author_facet | Vera Martins Mafalda Jesus Luísa Pereira Cristina Monteiro Ana Paula Duarte Manuel Morgado |
| author_sort | Vera Martins |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-10T20:58:50Z |
| format | Article |
| id | doaj.art-8cba7f06b9a04f36b3f8ef464504e54d |
| institution | Directory Open Access Journal |
| issn | 1424-8247 |
| language | English |
| last_indexed | 2024-03-10T20:58:50Z |
| publishDate | 2023-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceuticals |
| spelling | doaj.art-8cba7f06b9a04f36b3f8ef464504e54d2023-11-19T17:41:04ZengMDPI AGPharmaceuticals1424-82472023-09-011610134010.3390/ph16101340Hematological Events Potentially Associated with CDK4/6 Inhibitors: An Analysis from the European Spontaneous Adverse Event Reporting SystemVera Martins0Mafalda Jesus1Luísa Pereira2Cristina Monteiro3Ana Paula Duarte4Manuel Morgado5Health Sciences Faculty, University of Beira Interior (FCS-UBI), 6200-506 Covilhã, PortugalHealth Sciences Faculty, University of Beira Interior (FCS-UBI), 6200-506 Covilhã, PortugalCMA-UBI, Centre of Mathematics and Applications, University of Beira Interior, Rua Marquês d’Ávila e Bolama, 6201-001 Covilhã, PortugalHealth Sciences Faculty, University of Beira Interior (FCS-UBI), 6200-506 Covilhã, PortugalHealth Sciences Faculty, University of Beira Interior (FCS-UBI), 6200-506 Covilhã, PortugalHealth Sciences Faculty, University of Beira Interior (FCS-UBI), 6200-506 Covilhã, PortugalCyclin-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.https://www.mdpi.com/1424-8247/16/10/1340CDK4/6 inhibitorsabemaciclibpalbociclibribociclibhematological adverse drug reactionsleukopenia |
| spellingShingle | Vera Martins Mafalda Jesus Luísa Pereira Cristina Monteiro Ana Paula Duarte Manuel Morgado Hematological Events Potentially Associated with CDK4/6 Inhibitors: An Analysis from the European Spontaneous Adverse Event Reporting System Pharmaceuticals CDK4/6 inhibitors abemaciclib palbociclib ribociclib hematological adverse drug reactions leukopenia |
| title | Hematological Events Potentially Associated with CDK4/6 Inhibitors: An Analysis from the European Spontaneous Adverse Event Reporting System |
| title_full | Hematological Events Potentially Associated with CDK4/6 Inhibitors: An Analysis from the European Spontaneous Adverse Event Reporting System |
| title_fullStr | Hematological Events Potentially Associated with CDK4/6 Inhibitors: An Analysis from the European Spontaneous Adverse Event Reporting System |
| title_full_unstemmed | Hematological Events Potentially Associated with CDK4/6 Inhibitors: An Analysis from the European Spontaneous Adverse Event Reporting System |
| title_short | Hematological Events Potentially Associated with CDK4/6 Inhibitors: An Analysis from the European Spontaneous Adverse Event Reporting System |
| title_sort | hematological events potentially associated with cdk4 6 inhibitors an analysis from the european spontaneous adverse event reporting system |
| topic | CDK4/6 inhibitors abemaciclib palbociclib ribociclib hematological adverse drug reactions leukopenia |
| url | https://www.mdpi.com/1424-8247/16/10/1340 |
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