重要性：内分泌治疗 (ET) 和细胞周期蛋白依赖性激酶 4/6 (iCDK4/6s) 抑制剂是乳腺癌的标准治疗方法。然而，有关 ET 潜在神经认知影响的数据仍然不一致，并且 iCDK4/6 的数据也很少。目的：评估 ET 和 iCDK4/6s 是否与神经认知障碍 (NCI) 相关。方法：我们使用世界卫生组织数据库 VigiBase® 中的 NCI 真实观察病例来进行不成比例分析。病例定义为接受 ET 或 iCDK4/6 治疗的女性出现任何 NCI 症状。研究期间是从 VigiBase® 与 iCDK4/6s 报告的首次不良事件之日（2014 年 1 月 1 日）到数据提取之日（2022 年 3 月 16 日）。在我们的主要分析中，我们计算了根据年龄调整的报告比值比 (ROR)，以确定 NCI 与单独或与 iCDK4/6 组合的个体 ET 之间的潜在关联。我们还按 NCI 类别进行了亚组分析。结果：我们分别确定了 2.582 份和 1.943 份与 ET 和 iCDK4/6 相关的 NCI 报告。 NCI 与每个 ET 显着相关[阿那曲唑：n = 405，aROR = 1.52（95% CI：1.37-1.67）；来曲唑：n = 741，aROR = 1.37（95% CI：1.27-1.47）；依西美坦：n = 316，aROR = 1.37（95% CI：1.22-1.53​​）；他莫昔芬：n = 311，aROR = 1.25（95% CI：1.12-1.40）；和氟维司群：n = 319，aROR = 1.19 (95% CI: 1.06-1.33)]，并且仅与 palbociclib 一起用于 iCDK4/6s [n = 1,542，aROR = 1.41 (95% CI: 1.34-1.48)]。结论：这些研究结果表明，在接受乳腺癌治疗的女性中，所有 ET 都可能与 NCI 相关。然而，在 iCDK4/6 中，NCI 可能特定于 palbociclib。 NCI 最常涉及学习和记忆以及语言。治疗对神经认知的影响需要更好的考虑和管理。版权所有 © 2023 Prevost、Chretien、Minoc、Dolladille、Da-Silva、Nehme、Joly、Lelong-Boulouard 和 Bastien。

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.Copyright © 2023 Prevost, Chretien, Minoc, Dolladille, Da-Silva, Nehme, Joly, Lelong-Boulouard and Bastien.