Drowne Taylor, Armgardt Emily, Svoboda Alison
Department of Pharmacy, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Department of Pharmacy, Robert H. Lurie Comprehensive Cancer Center of Northwestern, Chicago, IL, USA.
J Oncol Pharm Pract. 2025 Jan;31(1):141-146. doi: 10.1177/10781552241279189. Epub 2024 Aug 28.
Hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer is the most common subtype. Abemaciclib, an inhibitor of cyclin-dependent kinases 4 and 6, was approved to reduce risk of recurrence in high-risk, HR+, HER2-, early breast cancer based on the monarchE trial. The most common adverse events reported in monarchE were diarrhea, neutropenia, and fatigue. Real-world tolerability data and incidence of adverse events with abemaciclib in the adjuvant setting versus the metastatic setting is lacking.
This is a retrospective analysis of HR+, HER2- breast cancer patients on abemaciclib from March 2018 to September 2021 at Robert H. Lurie Comprehensive Cancer Center in Chicago, Illinois. Incidence, grade of adverse events, dose reductions, and discontinuations were evaluated in patients taking abemaciclib in the adjuvant setting and the metastatic setting.
Of the 30 patients included in this analysis, 100% experienced an adverse event of any grade. During treatment, 12.5% treated in the adjuvant setting and 35.7% in the metastatic setting experienced grade ≥3 adverse events. Adverse events leading to discontinuation of abemaciclib occurred in 18.8% of patients in the adjuvant setting and 57.1% in the metastatic setting.
This data suggests abemaciclib is better tolerated in high-risk, HR+, HER2-, node-positive, early breast cancer treated in the adjuvant setting compared to the metastatic setting. Management of adverse events is crucial to help patients stay on therapy to improve clinical outcomes. Real-world tolerability of abemaciclib in both the adjuvant and metastatic settings is of importance.
激素受体阳性（HR+）、人表皮生长因子受体2阴性（HER2-）乳腺癌是最常见的亚型。阿贝西利是一种细胞周期蛋白依赖性激酶4和6的抑制剂，基于monarchE试验被批准用于降低高危、HR+、HER2-早期乳腺癌的复发风险。monarchE试验中报告的最常见不良事件为腹泻、中性粒细胞减少和疲劳。目前缺乏阿贝西利在辅助治疗与转移性治疗环境中的真实世界耐受性数据及不良事件发生率。
这是一项对2018年3月至2021年9月在伊利诺伊州芝加哥市罗伯特·H·卢里综合癌症中心接受阿贝西利治疗的HR+、HER2-乳腺癌患者的回顾性分析。对接受阿贝西利辅助治疗和转移性治疗的患者的不良事件发生率、分级、剂量减少和停药情况进行了评估。
在该分析纳入的30例患者中，100%经历了任何级别的不良事件。治疗期间，辅助治疗组有12.5%的患者、转移性治疗组有35.7%的患者发生≥3级不良事件。导致停用阿贝西利的不良事件在辅助治疗组18.8%的患者中出现，在转移性治疗组57.1%的患者中出现。
该数据表明，与转移性治疗相比，阿贝西利在辅助治疗高危、HR+、HER2-、淋巴结阳性早期乳腺癌时耐受性更好。不良事件的管理对于帮助患者持续接受治疗以改善临床结局至关重要。阿贝西利在辅助治疗和转移性治疗环境中的真实世界耐受性具有重要意义。
