背景:在君主时代,在中位随访42个月时,abemaciclib在无侵袭性疾病生存期和可耐受的安全性方面表现出持续获益.没有预期的疾病相关症状,辅助治疗应保持生活质量(QoL).所有病人都关闭了abemaciclib,我们报告了整个2年治疗期和随访期间患者报告的最新结局(PRO).
方法:患者完成了包括FACT-B,FACT-ES,和FACIT-基线疲劳,治疗期间3、6、12、18和24个月,以及停药后1、6和12个月。混合效应重复测量模型估计了QoL量表和单个项目的组内和组间基线的变化。预先指定了有意义的变化,没有进行统计检验。总结了对与相关不良事件和治疗麻烦相关的项目的反应频率。
结果:在基线时,PRO仪器的完成率>96%。所有QoL量表相对于基线的平均变化在臂内和臂之间在数值上相似(即,低于预定阈值)。所有单个项目都观察到了同样的情况,除了腹泻.在abemaciclib手臂内,在3个月和6个月时观察到腹泻的有意义的差异(在5点量表上平均增加1.19和1.03点,分别)。治疗期间,两方面的大多数患者(69-78%)报告受到副作用的困扰“一点点”或“根本没有”。总的来说,手臂之间的疲劳模式相似。在治疗后随访期间,两组中的PRO与基线相似。
结论:PRO研究结果证实了abemaciclib的可耐受和可逆毒性。在内分泌治疗中添加abemaciclib辅助治疗后,QoL得以保留,支持其在HR+患者中的使用,HER2-,高危早期乳腺癌.
BACKGROUND: In
monarchE, abemaciclib demonstrated a sustained benefit in invasive disease-free survival and a tolerable safety profile at 42-months median follow-up. With no expected disease-related symptoms, therapies in the adjuvant setting should preserve quality of life (QoL). With all patients off abemaciclib, we report updated patient-reported outcomes (PROs) for the full 2-year treatment period and follow-up.
METHODS: Patients completed PROs including FACT-B, FACT-ES, and FACIT-Fatigue at baseline, 3, 6, 12, 18, and 24 months during treatment, and 1, 6, and 12 months after treatment discontinuation. Mixed effects repeated measures model estimated changes from baseline within and between arms for QoL scales and individual items. Meaningful changes were prespecified and no statistical testing was performed. Frequencies of responses to items associated with relevant adverse events and treatment bother were summarized.
RESULTS: At baseline, completion rates for PRO instruments were >96 %. Mean changes from baseline for all QoL scales were numerically similar within and between arms (ie, less than prespecified thresholds). The same was observed for all individual items, except diarrhea. Within abemaciclib arm, meaningful differences for diarrhea were observed at 3 and 6 months (mean increases of 1.19 and 1.03 points on 5-point scale, respectively). During treatment, most patients in both arms (69-78 %) reported being bothered \"a little bit\" or \"not at all\" by side effects. Overall, patterns for fatigue were similar between arms. During post-treatment follow-up, PROs in both arms were similar to baseline.
CONCLUSIONS: PRO findings confirm a tolerable and reversible toxicity profile for abemaciclib. QoL was preserved with the addition of adjuvant abemaciclib to endocrine therapy, supporting its use in patients with HR+, HER2-, high-risk early breast cancer.