(1) Background: Abemaciclib combined with endocrine therapy is a standard first- or later-line of treatment for HR+/HER2− metastatic breast cancer (MBC). The aim of this retrospective cohort study was to describe the outcomes of patients treated in a real-world setting, with particular focus on elderly patients. (2) Patients and methods: Patients treated with abemaciclib between November 2019 and February 2022 were included in the study. Data were collected from electronic medical records. The primary objective was to determine real-world progression-free survival (rwPFS), and secondary objectives included median overall survival (mOS) and safety. (3) Results: Analysis included 134 patients, with a median follow-up of 42 months. Median age was 62 years, with 29.9% aged 70+ years. A total of 51.5% of patients received abemaciclib in first-line, predominantly with aromatase inhibitor (68.1%). Median rwPFS was 21 in first-line and 20 months in the second-line, with no significant difference between treatment lines (HR 0.96;p= 0.88). Patients treated in the third- or later-line had a significantly shorter rwPFS, at 7 months (HR 1.48,p= 0.003). mOS was not reached in the first-line setting. For second- and third- or later-lines, mOS was 29 and 19 months, respectively. There was no significant difference in mOS between first- or second-line (HR 1.37,p= 0.36). In the 70+ group, median rwPFS was 15 months and mOS was 25 months with no significant difference compared to younger patients (rwPFS HR 1.1;p= 0.65; OS HR 1.4;p= 0.21). Most common adverse events (AEs) were diarrhoea (68.7%), anaemia (64.9%), and increased serum creatinine (63.4%). Grade 3/4 AEs were reported in 21.6% of patients. Dose reductions occurred in 30.6% of patients and were more frequent in patients 70+ (40%) compared to younger patients (28%); the difference was not significant (p= 0.22). At study cut-off, 64.9% of patients discontinued abemaciclib, primarily due to disease progression (73.5%). (4) Conclusions: Our study provides valuable insights into the effectiveness and safety of abemaciclib for the treatment of MBC. We observed comparable outcomes in terms of rwPFS and OS between the first two lines, suggesting consistent effectiveness across treatment lines. In addition, our findings suggest that older age (70+) does not significantly impact the effectiveness and tolerability of abemaciclib, although the careful monitoring and management of AEs are warranted.
(1) 背景：阿贝西利联合内分泌治疗是HR+/HER2−转移性乳腺癌（MBC）标准的一线或后线治疗方案。本回顾性队列研究旨在描述真实世界环境中接受治疗患者的结局，特别关注老年患者群体。(2) 患者与方法：研究纳入2019年11月至2022年2月期间接受阿贝西利治疗的患者。数据来源于电子病历系统。主要研究目标是确定真实世界无进展生存期（rwPFS），次要目标包括中位总生存期（mOS）和安全性评估。(3) 结果：共134例患者纳入分析，中位随访时间42个月。患者中位年龄62岁，其中29.9%为70岁及以上。51.5%的患者在一线治疗中接受阿贝西利，主要联合芳香化酶抑制剂（68.1%）。一线治疗中位rwPFS为21个月，二线为20个月，治疗线数间无显著差异（HR 0.96；p=0.88）。三线及以上治疗患者的rwPFS显著缩短至7个月（HR 1.48，p=0.003）。一线治疗组未达到中位OS。二线及三线以上治疗组的中位OS分别为29个月和19个月。一线与二线治疗的OS无显著差异（HR 1.37，p=0.36）。在70岁及以上患者组中，中位rwPFS为15个月，中位OS为25个月，与年轻患者相比无显著差异（rwPFS HR 1.1；p=0.65；OS HR 1.4；p=0.21）。最常见不良事件为腹泻（68.7%）、贫血（64.9%）和血肌酐升高（63.4%）。21.6%的患者报告3/4级不良事件。30.6%的患者需要剂量调整，70岁以上患者调整比例（40%）高于年轻患者（28%），但差异无统计学意义（p=0.22）。截至研究截止时，64.9%的患者停用阿贝西利，主要原因为疾病进展（73.5%）。(4) 结论：本研究为阿贝西利治疗MBC的有效性和安全性提供了重要参考。我们观察到前两线治疗在rwPFS和OS方面具有可比性，提示其疗效在不同治疗线数间保持稳定。此外，研究结果表明高龄（70岁以上）并未显著影响阿贝西利的疗效和耐受性，但仍需对不良事件进行密切监测和管理。
Abemaciclib for the Treatment of HR+HER2− Metastatic Breast Cancer: An Institutional Experience
肿瘤(癌症)患者之家