Background and Purpose: Adherence to oral anticancer therapy correlates with outcome. Lenalidomide (LEN) is an oral mainstay treatment for multiple myeloma (MM), administered in 21-day/7-day (on/off) cycles. Data on LEN adherence is limited. Electronic monitoring (EM) represents the most reliable adherence assessment method. Experimental Approach: We conducted a prospective observational study using electronic medication event monitoring (MEMS®) in lenalidomide-naïve multiple myeloma patients to quantify adherence during on/off cycles and identify patterns of non-adherence in real-world practice. On and off cycles were determined semi-automatically. Implementation adherence was calculated as the proportion of prescribed drug taken, during each on cycle and across all on cycles. Daily adherence predictors were analyzed using logistic regression with generalized estimating equations. Key Results: Eighty-five patients were included. Median age was 68 years, 66% received LEN as a second-line treatment, 75% of patients perfectly adhered to the recommended 21/7-day on/off cycle. Median implementation adherence was 100%. Only 4% of patients had a proportion of doses taken below 90%. All doses were taken by 51% of patients, while 9% missed ≥4 doses. Among the 13 predictors investigated, only age under 80 and participation in a support group were statistically significant. Conclusions: this novel assessment of LEN adherence in MM patients demonstrated high implementation adherence and cycle duration compliance.
背景与目的:口服抗癌治疗的依从性与疗效密切相关。来那度胺(LEN)是多发性骨髓瘤(MM)的主要口服治疗药物,采用21天用药/7天停药(用药期/停药期)的周期方案。目前关于LEN依从性的数据有限,而电子监测(EM)是最可靠的依从性评估方法。实验方法:我们开展了一项前瞻性观察研究,在未使用过来那度胺的多发性骨髓瘤患者中采用电子药物事件监测系统(MEMS®),以量化用药期/停药期周期内的依从性,并识别真实世界实践中不依从的模式。用药期与停药期通过半自动方式确定。执行依从性通过计算每个用药期及所有用药期内实际服药剂量占处方剂量的比例进行评估。采用广义估计方程的逻辑回归模型分析每日依从性的预测因素。主要结果:研究共纳入85例患者,中位年龄68岁,66%的患者将LEN作为二线治疗。75%的患者完全遵循推荐的21天/7天用药/停药周期。中位执行依从性为100%,仅4%的患者服药比例低于90%。51%的患者服用了全部剂量,而9%的患者漏服≥4剂。在研究的13个预测因素中,仅年龄低于80岁和参与支持小组具有统计学显著性。结论:这项对多发性骨髓瘤患者LEN依从性的创新评估显示,患者的执行依从性和周期时长遵循度均较高。
High Implementation Adherence to Lenalidomide in Multiple Myeloma