Background/Objectives: This study aimed to assess real-world toxicity and efficacy data of patients with early and advanced breast cancer (BC) who received treatment with abemaciclib. Methods: This was a prospective/retrospective multi-institutional collection of clinicopathological, toxicity, and outcome data from patients with early or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative BC who received treatment with abemaciclib in combination with endocrine therapy in departments of oncology in Greece. Treatment combinations of abemaciclib with any endocrine therapy were accepted. The primary end point was toxicity rate in all patients of the study. Results: From June/2021 to May/2024, 245 women received abemaciclib/endocrine combination therapy; the median age was 57 years. Of these, 169 (69%) received abemaciclib as adjuvant therapy for early-stage disease, while 76 (31%) were treated for advanced BC. At the time of the data cutoff, 133 (84.7%) patients remained in the 2-year treatment period. The most common adverse event (AE) was diarrhea (51%), primarily Grade ≤ 2. Dose modifications due to AEs were required in 19.2% of cases, while treatment discontinuation occurred in 5.1%. There was no difference in dose modification/discontinuation rates between older patients (>65 years) and the remaining patients. For early-stage BC patients, the 2-year DFS and OS rates were 90.8% and 100%, respectively. In patients with advanced cancer (70, 30.8%), 1-year PFS and OS rates were 78% and 96.3%, respectively. Conclusions: This study confirms the safety and effectiveness of abemaciclib in alignment with registrational trials offering valuable insights into toxicity management and clinical outcomes in routine practice without identifying new safety concerns. Clinical Trial Registration: ClinicalTrials.gov NCT04985058.
背景/目的：本研究旨在评估接受阿贝西利治疗的早期及晚期乳腺癌患者的真实世界毒性和疗效数据。方法：本研究为前瞻性/回顾性多中心临床数据收集，纳入希腊肿瘤科接受阿贝西利联合内分泌治疗的早期或转移性激素受体阳性、人表皮生长因子受体2阴性乳腺癌患者，收集其临床病理特征、毒性反应及预后数据。阿贝西利与任何内分泌治疗的联合方案均被纳入。主要终点为全研究人群的毒性发生率。结果：2021年6月至2024年5月期间，共245例女性患者接受阿贝西利/内分泌联合治疗，中位年龄57岁。其中169例（69%）因早期疾病接受阿贝西利辅助治疗，76例（31%）因晚期乳腺癌接受治疗。截至数据截止时，133例（84.7%）患者仍在2年治疗期内。最常见的不良事件为腹泻（51%），主要为≤2级。19.2%的患者因不良事件需要调整剂量，5.1%的患者终止治疗。老年患者（>65岁）与其余患者的剂量调整/终止治疗率无显著差异。早期乳腺癌患者的2年无病生存率和总生存率分别为90.8%和100%。晚期癌症患者（70例，30.8%）的1年无进展生存率和总生存率分别为78%和96.3%。结论：本研究证实阿贝西利的安全性和有效性与注册试验结果一致，为临床实践中的毒性管理和临床结局提供了重要参考，未发现新的安全性问题。临床试验注册号：ClinicalTrials.gov NCT04985058。
肿瘤(癌症)患者之家