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Life sciences · Journal article
Frontiers in Pharmacology · October 23, 2026
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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.