Neurocognitive impairment in females with breast cancer treated with endocrine therapy and CDK4/6 inhibitors: a pharmacovigilance study using the World Health Organization’s database
Importance: Endocrine therapies (ETs) and inhibitors of cyclin-dependent kinases-4/6 (iCDK4/6s) are a standard treatment in breast cancer. However, data on potential neurocognitive impacts remain inconsistent for ET and are scarce for iCDK4/6s.Objective: To evaluate whether ET and iCDK4/6s are assoc...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-10-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2023.1278682/full |
| _version_ | 1797655204067278848 |
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| author | Rachel Prevost Basile Chretien Elise-Marie Minoc Elise-Marie Minoc Charles Dolladille Charles Dolladille Angélique Da-Silva Ahmad Nehme Florence Joly Florence Joly Véronique Lelong-Boulouard Véronique Lelong-Boulouard Etienne Bastien Etienne Bastien |
| author_facet | Rachel Prevost Basile Chretien Elise-Marie Minoc Elise-Marie Minoc Charles Dolladille Charles Dolladille Angélique Da-Silva Ahmad Nehme Florence Joly Florence Joly Véronique Lelong-Boulouard Véronique Lelong-Boulouard Etienne Bastien Etienne Bastien |
| author_sort | Rachel Prevost |
| collection | DOAJ |
| description | Importance: Endocrine therapies (ETs) and inhibitors of cyclin-dependent kinases-4/6 (iCDK4/6s) are a standard treatment in breast cancer. However, data on potential neurocognitive impacts remain inconsistent for ET and are scarce for iCDK4/6s.Objective: To evaluate whether ET and iCDK4/6s are associated with neurocognitive impairment (NCI).Methods: We used observational, real-world cases of NCI from the World Health Organization’s database VigiBase® to perform disproportionality analysis. Cases were defined as any symptom of NCI in females treated with ETs or iCDK4/6s. The study period was from the date of the first adverse event reported in VigiBase® with iCDK4/6s (1 January 2014) until the date of data extraction (16 March 2022). In our primary analysis, we calculated the reporting odds ratio (ROR) adjusted for age to identify a potential association between NCI and individual ETs in isolation or in combination with iCDK4/6s. We also performed subgroup analyses by the NCI class.Results: We identified 2.582 and 1.943 reports of NCI associated with ETs and iCDK4/6s, respectively. NCI was significantly associated with each ET [anastrozole: n = 405, aROR = 1.52 (95% CI: 1.37–1.67); letrozole: n = 741, aROR = 1.37 (95% CI: 1.27–1.47); exemestane: n = 316, aROR = 1.37 (95% CI: 1.22–1.53); tamoxifen: n = 311, aROR = 1.25 (95% CI: 1.12–1.40); and fulvestrant: n = 319, aROR = 1.19 (95% CI: 1.06–1.33)] and only with palbociclib for iCDK4/6s [n = 1,542, aROR = 1.41 (95% CI: 1.34–1.48)].Conclusion: These findings suggest that in females treated for breast cancer, all ETs may be associated with NCI. However, amongst iCDK4/6s, NCI may be specific to palbociclib. NCI most frequently involved learning and memory as well as language. Neurocognitive impact of treatments requires better consideration and management. |
| first_indexed | 2024-03-11T17:10:48Z |
| format | Article |
| id | doaj.art-dba931f08fae49b180d553e273171499 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-03-11T17:10:48Z |
| publishDate | 2023-10-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-dba931f08fae49b180d553e2731714992023-10-20T06:11:46ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122023-10-011410.3389/fphar.2023.12786821278682Neurocognitive impairment in females with breast cancer treated with endocrine therapy and CDK4/6 inhibitors: a pharmacovigilance study using the World Health Organization’s databaseRachel Prevost0Basile Chretien1Elise-Marie Minoc2Elise-Marie Minoc3Charles Dolladille4Charles Dolladille5Angélique Da-Silva6Ahmad Nehme7Florence Joly8Florence Joly9Véronique Lelong-Boulouard10Véronique Lelong-Boulouard11Etienne Bastien12Etienne Bastien13Department of Pharmacology, University Teaching Hospital of Caen-Normandie, Caen, FranceDepartment of Pharmacology, University Teaching Hospital of Caen-Normandie, Caen, FranceDepartment of Pharmacology, University Teaching Hospital of Caen-Normandie, Caen, FranceNormandie University, UNICAEN, INSERM COMETE, U1075, Caen, FranceDepartment of Pharmacology, University Teaching Hospital of Caen-Normandie, Caen, FranceNormandie University, UNICAEN, INSERM U1086 “Interdisciplinary Research Unit for Cancers Prevention and Treatment” (ANTICIPE), Caen, FranceDepartment of Pharmacology, University Teaching Hospital of Caen-Normandie, Caen, FranceDepartment of Neurology, University Teaching Hospital of Caen-Normandie, Caen, FranceNormandie University, UNICAEN, INSERM U1086 “Interdisciplinary Research Unit for Cancers Prevention and Treatment” (ANTICIPE), Caen, FranceComprehensive Cancer Center Baclesse, Unicancer, Caen, FranceDepartment of Pharmacology, University Teaching Hospital of Caen-Normandie, Caen, FranceNormandie University, UNICAEN, INSERM COMETE, U1075, Caen, FranceDepartment of Pharmacology, University Teaching Hospital of Caen-Normandie, Caen, FranceComprehensive Cancer Center Baclesse, Unicancer, Caen, FranceImportance: Endocrine therapies (ETs) and inhibitors of cyclin-dependent kinases-4/6 (iCDK4/6s) are a standard treatment in breast cancer. However, data on potential neurocognitive impacts remain inconsistent for ET and are scarce for iCDK4/6s.Objective: To evaluate whether ET and iCDK4/6s are associated with neurocognitive impairment (NCI).Methods: We used observational, real-world cases of NCI from the World Health Organization’s database VigiBase® to perform disproportionality analysis. Cases were defined as any symptom of NCI in females treated with ETs or iCDK4/6s. The study period was from the date of the first adverse event reported in VigiBase® with iCDK4/6s (1 January 2014) until the date of data extraction (16 March 2022). In our primary analysis, we calculated the reporting odds ratio (ROR) adjusted for age to identify a potential association between NCI and individual ETs in isolation or in combination with iCDK4/6s. We also performed subgroup analyses by the NCI class.Results: We identified 2.582 and 1.943 reports of NCI associated with ETs and iCDK4/6s, respectively. NCI was significantly associated with each ET [anastrozole: n = 405, aROR = 1.52 (95% CI: 1.37–1.67); letrozole: n = 741, aROR = 1.37 (95% CI: 1.27–1.47); exemestane: n = 316, aROR = 1.37 (95% CI: 1.22–1.53); tamoxifen: n = 311, aROR = 1.25 (95% CI: 1.12–1.40); and fulvestrant: n = 319, aROR = 1.19 (95% CI: 1.06–1.33)] and only with palbociclib for iCDK4/6s [n = 1,542, aROR = 1.41 (95% CI: 1.34–1.48)].Conclusion: These findings suggest that in females treated for breast cancer, all ETs may be associated with NCI. However, amongst iCDK4/6s, NCI may be specific to palbociclib. NCI most frequently involved learning and memory as well as language. Neurocognitive impact of treatments requires better consideration and management.https://www.frontiersin.org/articles/10.3389/fphar.2023.1278682/fullbreast cancerendocrine therapycyclin-dependent kinase 4/6 inhibitorneurocognitive impairmentpharmacoepidemiology |
| spellingShingle | Rachel Prevost Basile Chretien Elise-Marie Minoc Elise-Marie Minoc Charles Dolladille Charles Dolladille Angélique Da-Silva Ahmad Nehme Florence Joly Florence Joly Véronique Lelong-Boulouard Véronique Lelong-Boulouard Etienne Bastien Etienne Bastien Neurocognitive impairment in females with breast cancer treated with endocrine therapy and CDK4/6 inhibitors: a pharmacovigilance study using the World Health Organization’s database Frontiers in Pharmacology breast cancer endocrine therapy cyclin-dependent kinase 4/6 inhibitor neurocognitive impairment pharmacoepidemiology |
| title | Neurocognitive impairment in females with breast cancer treated with endocrine therapy and CDK4/6 inhibitors: a pharmacovigilance study using the World Health Organization’s database |
| title_full | Neurocognitive impairment in females with breast cancer treated with endocrine therapy and CDK4/6 inhibitors: a pharmacovigilance study using the World Health Organization’s database |
| title_fullStr | Neurocognitive impairment in females with breast cancer treated with endocrine therapy and CDK4/6 inhibitors: a pharmacovigilance study using the World Health Organization’s database |
| title_full_unstemmed | Neurocognitive impairment in females with breast cancer treated with endocrine therapy and CDK4/6 inhibitors: a pharmacovigilance study using the World Health Organization’s database |
| title_short | Neurocognitive impairment in females with breast cancer treated with endocrine therapy and CDK4/6 inhibitors: a pharmacovigilance study using the World Health Organization’s database |
| title_sort | neurocognitive impairment in females with breast cancer treated with endocrine therapy and cdk4 6 inhibitors a pharmacovigilance study using the world health organization s database |
| topic | breast cancer endocrine therapy cyclin-dependent kinase 4/6 inhibitor neurocognitive impairment pharmacoepidemiology |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2023.1278682/full |
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