Department of Pharmacy, Osaka Medical and Pharmaceutical University Hospital, 2-7, Daigaku-Machi, Takatsuki, Osaka, 569-8686, Japan.
Department of Hospital Quality and Safety Management, Osaka Medical and Pharmaceutical University Hospital, 2-7, Daigaku-Machi, Takatsuki, Osaka, 569-8686, Japan.
BMC Cancer. 2024 Oct 30;24(1):1335. doi: 10.1186/s12885-024-13091-y.
This study explored the predictors of abemaciclib discontinuation, a cyclin-dependent kinase 4 and 6 inhibitor, in patients with breast cancer.
Between November 2018 and March 2023, 147 patients with breast cancer treated with abemaciclib at Osaka Medical and Pharmaceutical University Hospital and Kindai University Nara Hospital were included. The exclusion criteria were as follows: lack of blood testing within 2 weeks prior to starting abemaciclib therapy, transfer to another facility after the commencement of abemaciclib therapy, and discontinuation of abemaciclib therapy due to the diagnosis of another cancer. The duration from the initiation of abemaciclib to discontinuation for any reason and to temporary suspension or dose reduction due to adverse events were analyzed as outcome variables using multivariate Cox regression analysis.
Baseline weight < 54 kg, bone metastases, and hemoglobin level ≤ 12.4 g/dL were independent predictors of abemaciclib discontinuation for any reason. The main adverse events leading to abemaciclib discontinuation were liver enzyme elevation and gastrointestinal symptoms. Additionally, focusing on the adverse event of abemaciclib, a baseline weight < 54 kg was an independent predictor of temporary suspension or dose reduction due to adverse events. The most common adverse events leading to temporary suspension or dose reduction were neutropenia and diarrhea.
Patients with lower body weight are more susceptible to the adverse events of abemaciclib, increasing their risk of treatment discontinuation. In such patients, strict monitoring of adverse events and consideration of more frequent medical visits are necessary from the start of abemaciclib therapy.
本研究旨在探讨乳腺癌患者使用 CDK4/6 抑制剂阿贝西利(abemaciclib)停药的预测因素。
本研究纳入了 2018 年 11 月至 2023 年 3 月期间在大阪医科药科大学医院和近畿大学奈良医院接受阿贝西利治疗的 147 例乳腺癌患者。排除标准为:开始阿贝西利治疗前 2 周内未进行血液检查、开始阿贝西利治疗后转至其他医疗机构以及因诊断出其他癌症而停用阿贝西利治疗。使用多变量 Cox 回归分析分析了从开始使用阿贝西利到因任何原因停药以及因不良事件临时停药或减少剂量的持续时间作为结局变量。
基线体重<54kg、骨转移和血红蛋白水平≤12.4g/dL 是阿贝西利因任何原因停药的独立预测因素。导致阿贝西利停药的主要不良事件为肝酶升高和胃肠道症状。此外,针对阿贝西利的不良事件,基线体重<54kg 是因不良事件临时停药或减少剂量的独立预测因素。导致临时停药或减少剂量的最常见不良事件为中性粒细胞减少和腹泻。
体重较低的患者更容易发生阿贝西利的不良事件,增加了停药的风险。对于此类患者,从开始使用阿贝西利治疗起,就需要密切监测不良事件,并考虑更频繁的就诊。