Dementia-related risk associated with endocrine and targeted therapy strategies in breast cancer: a real-world pharmacovigilance analysis
- 1Longhua Clinical Medical College, Shanghai University of Traditional Chinese Medicine
- 2Department of Traditional Chinese Medicine, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- 3Department of Traditional Chinese Medicine Breast Disease, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Abstract
Background: In clinical practice, adjuvant endocrine and targeted (ET) therapy strategies for hormone receptor-positive (HR+) breast cancer are constantly evolving. The long-term cognitive impact of such adjuvant treatment on patients remains unclear.
Methods: This study mined data from the FDA Adverse Event Reporting System (FAERS) from 2010Q1 to 2025Q2 to examine the relationship between ET therapy strategies and adverse events (AEs) related to dementia. Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) containing “broad” and “narrow” preferred terms (PTs) for dementia were used to systematically identify AE reports associated with dementia. The disproportionality analysis was conducted using the Empirical Bayes Geometric Mean (EBGM) calculated by the Multi-Item Gamma Poisson Shrinker (MGPS) and the proportional reporting ratio together with chi-square (PRR, χ2).
Results: As a whole, risk signals are negative in narrow or broad dementia (narrow: EBGM05 1.27, PRR 1.32 [χ ² 5.75]; broad: EBGM05 1.02, PRR 1.03 [χ ² 2.88]). In subgroup analyses, positive signals of narrow dementia were identified for anastrozole monotherapy (n = 20, EBGM05 4.00, PRR 4.68 [χ ² 53.20]) and exemestane monotherapy (n = 9, EBGM05 2.10, PRR 2.64 [χ ² 8.85]) in female adult breast cancer cases, as well as for anastrozole monotherapy in reporters over 50 years old (n = 20, EBGM05 2.52, PRR 3.67 [χ ² 39.87]).
Conclusion: This FAERS-based pharmacovigilance analysis identifies subgroup-specific narrow-spectrum dementia safety signals for aromatase inhibitor monotherapy in breast cancer patients, most notably anastrozole in women aged over 50 years. These hypothesis-generating observations warrant prospective validation.
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BibTeX
@article{cui2026dementiarelated,
title = {{Dementia-related risk associated with endocrine and targeted therapy strategies in breast cancer: a real-world pharmacovigilance analysis}},
author = {Ruolin Cui and Yulian Yin and Hongfeng Chen},
journal = {Frontiers in Pharmacology},
year = {2026},
month = oct,
doi = {10.3389/fphar.2026.1855112},
url = {https://www.frontiersin.org/articles/10.3389/fphar.2026.1855112/full},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Dementia-related risk associated with endocrine and targeted therapy strategies in breast cancer: a real-world pharmacovigilance analysis
AU - Ruolin Cui
AU - Yulian Yin
AU - Hongfeng Chen
PY - 2026
DA - 2026/10/23
JO - Frontiers in Pharmacology
DO - 10.3389/fphar.2026.1855112
UR - https://www.frontiersin.org/articles/10.3389/fphar.2026.1855112/full
AB - Background: In clinical practice, adjuvant endocrine and targeted (ET) therapy strategies for hormone receptor-positive (HR+) breast cancer are constantly evolving. The long-term cognitive impact of such adjuvant treatment on patients remains unclear. Methods: This study mined data from the FDA Adverse Event Reporting System (FAERS) from 2010Q1 to 2025Q2 to examine the relationship between ET therapy strategies and adverse events (AEs) related to dementia. Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) containing “broad” and “narrow” preferred terms (PTs) for dementia were used to systematically identify AE reports associated with dementia. The disproportionality analysis was conducted using the Empirical Bayes Geometric Mean (EBGM) calculated by the Multi-Item Gamma Poisson Shrinker (MGPS) and the proportional reporting ratio together with chi-square (PRR, χ2). Results: As a whole, risk signals are negative in narrow or broad dementia (narrow: EBGM05 1.27, PRR 1.32 [χ ² 5.75]; broad: EBGM05 1.02, PRR 1.03 [χ ² 2.88]). In subgroup analyses, positive signals of narrow dementia were identified for anastrozole monotherapy (n = 20, EBGM05 4.00, PRR 4.68 [χ ² 53.20]) and exemestane monotherapy (n = 9, EBGM05 2.10, PRR 2.64 [χ ² 8.85]) in female adult breast cancer cases, as well as for anastrozole monotherapy in reporters over 50 years old (n = 20, EBGM05 2.52, PRR 3.67 [χ ² 39.87]). Conclusion: This FAERS-based pharmacovigilance analysis identifies subgroup-specific narrow-spectrum dementia safety signals for aromatase inhibitor monotherapy in breast cancer patients, most notably anastrozole in women aged over 50 years. These hypothesis-generating observations warrant prospective validation.
SN - 1663-9812
ER -