目标: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。Abemaciclib,细胞周期蛋白依赖性激酶4和6的抑制剂被批准用于降低高危人群的复发风险,HR+,HER2-,基于君主试验的早期乳腺癌。君主报告中最常见的不良事件是腹泻,中性粒细胞减少症,和疲劳。缺乏真实世界的耐受性数据和abemaciclib在辅助治疗与转移治疗中的不良事件发生率。
方法:这是HR+的回顾性分析,HER2-2018年3月至2021年9月在芝加哥RobertH.Lurie综合癌症中心接受abemaciclib治疗的乳腺癌患者,伊利诺伊州。发病率,不良事件等级,剂量减少,对在辅助治疗和转移治疗中服用abemaciclib的患者进行了停药评估。
方法:本分析纳入的30例患者中,100%经历过任何级别的不良事件。治疗期间,辅助治疗组的12.5%和转移治疗组的35.7%出现≥3级不良事件。导致abemaciclib停药的不良事件发生在辅助治疗的18.8%患者和转移治疗的57.1%患者中。
结论:这些数据表明abemaciclib在高危人群中的耐受性更好,HR+,HER2-,节点阳性,与转移组相比,辅助组治疗早期乳腺癌。不良事件的管理对于帮助患者保持治疗以改善临床结果至关重要。在辅助和转移环境中,abemaciclib的真实世界耐受性很重要。
OBJECTIVE: 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.
METHODS: 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.
METHODS: 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.
CONCLUSIONS: 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.