Department of Breast Oncology, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Tianjin, China.
Department of Geriatrics, Hebei General Hospital, Shijiazhuang, China.
Thorac Cancer. 2023 Jan;14(1):68-72. doi: 10.1111/1759-7714.14715. Epub 2022 Nov 9.
Our study evaluated the renal safety of abemaciclib plus endocrine therapy (ET) with bisphosphonate as a treatment option for hormone receptor positive, human epidermal growth factor receptor 2 (HER-2) negative (HR+/HER2-) advanced breast cancer (ABC), especially with bone metastasis.
Data were collected from HR+/HER2- ABC patients who received abemaciclib with ET between March 2021 and May 2022 in a single medical center in China. We performed an analysis of the change in serum creatine (Cr) and creatine clearance (CrCl), time to first abnormal Cr value, and Common Terminology Criteria for Adverse Events grade of increased creatinine.
A total of 210 patients were included in the final analysis, with a median age of 56 years and a median weight of 65 kg. Any grade laboratory-assessing increased Cr occurred in 87.1% of patients, while CrCl rarely went down to 30 ml/min. Associations between start dose with grade of increased Cr and menopausal status with alert value, which is defined as creatinine clearance <30 ml/min, were indicated.
This study shows that abemaciclib combined with bisphosphonate would be safe for renal function in HR+/HER2- ABC patients with bone metastases.
本研究评估了 abemaciclib 联合内分泌治疗(ET)加双膦酸盐作为激素受体阳性、人表皮生长因子受体 2(HER-2)阴性(HR+/HER2-)晚期乳腺癌(ABC)治疗选择的肾脏安全性,特别是对于有骨转移的患者。
本研究收集了 2021 年 3 月至 2022 年 5 月期间在中国一家单中心接受 abemaciclib 联合 ET 治疗的 HR+/HER2-ABC 患者的数据。我们分析了血清肌酐(Cr)和肌酐清除率(CrCl)的变化、首次异常 Cr 值的时间以及根据常见不良事件术语标准评估的肌酐升高的等级。
最终分析共纳入 210 例患者,中位年龄为 56 岁,中位体重为 65kg。87.1%的患者出现任何级别实验室评估的 Cr 升高,而 CrCl 很少降至 30ml/min。研究表明起始剂量与 Cr 升高等级以及绝经状态与警戒值(定义为肌酐清除率<30ml/min)之间存在关联。
本研究表明,abemaciclib 联合双膦酸盐对于有骨转移的 HR+/HER2-ABC 患者的肾功能是安全的。