细胞周期蛋白依赖性激酶 4/6 抑制剂治疗在晚期乳腺癌治疗女性中的应用：在社区药房中整合 ASCO/NCODA 以患者为中心的标准。

Cyclin-dependent kinase 4/6 inhibitor treatment use in women treated for advanced breast cancer: Integrating ASCO/NCODA patient-centered standards in a community pharmacy.

机构信息

Larivière and Massicotte Pharmacy, Montréal, Canada.

Department of Pharmacy, Centre hospitalier de l'Université de Montréal, Montréal, Canada.

出版信息

J Oncol Pharm Pract. 2023 Jul;29(5):1144-1153. doi: 10.1177/10781552221102884. Epub 2022 May 31.

DOI:10.1177/10781552221102884

PMID:35642282

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10302375/

Abstract

BACKGROUND

Outpatients treated with oral anti-cancer drugs, including selective cyclin-dependent kinase 4/6 inhibitors (CDK4/6i), may benefit from a pharmacy practice setting adapted to support proper oral anti-cancer drug monitoring. This real-world study aimed to characterize patient-centered pharmacy practice aligned with American Society of Clinical Oncology (ASCO)/National Community Oncology Dispensing Association (NCODA) standards and to describe its impact on CDK4/6i treatment use.

METHODS

This retrospective study included women with confirmed hormone receptor-positive/human epidermal growth factor 2 negative locally advanced or metastatic breast cancer treated with either palbociclib, abemaciclib or ribociclib combined with letrozole or fulvestrant. Pharmacists collected patient characteristics, clinical activities, and treatment patterns using data from the pharmacy chart. CDK4/6i treatment adherence rates were estimated based on medication claims data. Time-to-treatment discontinuation, a proxy for time-to-event, was assessed using the Kaplan-Meier estimate.

RESULTS

Of the 195 patients assessed for eligibility, 65 were included in this study. The median observation duration was 13.6 months. An average of seven pharmaceutical care activities (range 2.8-21.7) per patient was documented for each treatment cycle. The mean proportion of days covered was 89.6%. The median time-to-treatment discontinuation was estimated at 44.2 months in patients treated with CDK4/6i + letrozole and 17.0 months in patients treated with CDK4/6i + fulvestrant. The average relative dose intensity was 85%, and the benefits of treatment were maintained regardless of the relative dose intensity levels.

CONCLUSION

A structured patient-centered pharmacy practice model integrating the ASCO/NCODA patient-centered standards and ongoing communication with patients and healthcare providers ensure timely refills, close monitoring, and allows patients to achieve high adherence and persistence rates comparable to those reported in clinical trials.

摘要

背景

接受口服抗癌药物治疗的门诊患者，包括选择性细胞周期蛋白依赖性激酶 4/6 抑制剂（CDK4/6i），可能受益于适应支持适当的口服抗癌药物监测的药房实践设置。这项真实世界的研究旨在描述符合美国临床肿瘤学会（ASCO）/国家社区肿瘤配药协会（NCODA）标准的以患者为中心的药房实践，并描述其对 CDK4/6i 治疗使用的影响。

方法

这项回顾性研究纳入了接受哌柏西利、阿贝西利或瑞博西利联合来曲唑或氟维司群治疗的激素受体阳性/人表皮生长因子受体 2 阴性局部晚期或转移性乳腺癌女性患者。药剂师使用药房图表中的数据收集患者特征、临床活动和治疗模式。根据药物索赔数据估计 CDK4/6i 治疗的依从率。使用 Kaplan-Meier 估计来评估治疗中断时间，作为时间事件的替代指标。

结果

在评估合格性的 195 名患者中，有 65 名患者被纳入本研究。中位观察时间为 13.6 个月。每治疗周期记录了每位患者平均 7 项（范围 2.8-21.7）药物治疗活动。覆盖天数的平均比例为 89.6%。接受 CDK4/6i+来曲唑治疗的患者的中位治疗中断时间估计为 44.2 个月，接受 CDK4/6i+氟维司群治疗的患者为 17.0 个月。平均相对剂量强度为 85%，且治疗获益与相对剂量强度水平无关。