Department of Pharmacy, Ogaki Municipal Hospital, Ogaki, Japan.
Department of Laboratory of Clinical Pharmacy, Gifu Pharmaceutical University, Gifu, Japan.
J Pharm Pract. 2024 Dec;37(6):1258-1266. doi: 10.1177/08971900241247653. Epub 2024 Apr 23.
Appropriate adverse event (AE) management and maintenance of therapeutic intensity are necessary to achieve therapeutic benefits of CDK4/6 inhibitors (palbociclib and abemaciclib) in hormone receptor-positive, HER2-negative metastatic/recurrent breast cancer. This study was aimed at clarifying the effect of AEs associated with palbociclib and abemaciclib on treatment. A total of 62 and 49 patients were prescribed palbociclib and abemaciclib, respectively, at our hospital from January 1, 2018 to June 30, 2023. The rate and reasons for treatment discontinuation, interruption of administration, and changes in dose and dosing schedule, treatment duration, and relative dose intensity (RDI) were compared between the groups of patients prescribed the 2 treatments. Treatment discontinuation due to AEs occurred more frequently with abemaciclib (12 patients) because of interstitial lung disease and hepatic and renal events than with palbociclib (5 patients; = .008). Administration was interrupted in 57 (91.9%) and 35 (71.4%) patients treated with palbociclib and abemaciclib, respectively ( = .004). Dose reduction occurred in 37 (67.3%) and 19 (47.5%) patients treated with palbociclib and abemaciclib, respectively ( = .053). The median [range] treatment duration was 301 [21-1643] days for palbociclib and 238 [70-1526] days for abemaciclib (log-rank test, = .581). The median RDI was 59.7% and 59.6% for palbociclib and abemaciclib, respectively ( = .539). Although the AEs of palbociclib and abemaciclib affected the treatment considerably, the treatment duration and RDI were similar. CDK4/6 inhibitors should be selected based on the tolerability and manageability of each AE.
适当的不良反应 (AE) 管理和治疗强度的维持对于在激素受体阳性、HER2 阴性转移性/复发性乳腺癌中实现 CDK4/6 抑制剂(帕博西尼和阿贝西利)的治疗获益是必要的。本研究旨在阐明与帕博西尼和阿贝西利相关的 AE 对治疗的影响。2018 年 1 月 1 日至 2023 年 6 月 30 日,我院分别为 62 例和 49 例患者开具了帕博西利和阿贝西利。比较两组患者的治疗停药率和停药原因、给药中断率和给药中断原因、剂量和给药方案改变、治疗持续时间和相对剂量强度 (RDI)。因间质性肺病和肝肾功能事件,阿贝西利(12 例)导致 AE 停药的频率高于帕博西利(5 例; =.008)。帕博西利和阿贝西利治疗的患者中,分别有 57(91.9%)和 35(71.4%)例中断给药( =.004)。帕博西利和阿贝西利治疗的患者中,分别有 37(67.3%)和 19(47.5%)例减少剂量( =.053)。帕博西利的中位 [范围] 治疗持续时间为 301 [21-1643] 天,阿贝西利为 238 [70-1526] 天(对数秩检验, =.581)。帕博西利和阿贝西利的中位 RDI 分别为 59.7%和 59.6%( =.539)。虽然帕博西利和阿贝西利的 AE 对治疗有很大影响,但治疗持续时间和 RDI 相似。CDK4/6 抑制剂的选择应基于每种 AE 的耐受性和可管理性。