Pharmacy Department, Erlangen University Hospital, Erlangen, Germany.
Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Erlangen, Germany.
J Clin Oncol. 2021 Jun 20;39(18):1983-1994. doi: 10.1200/JCO.20.03088. Epub 2021 Apr 6.
Oral anticancer drugs (eg, kinase inhibitors) play an important role in cancer therapy. However, considerable challenges regarding medication safety of oral anticancer drugs have been reported. Randomized, controlled, multicenter studies on the impact of intensified clinical pharmacological/pharmaceutical care on patient safety and patient treatment perception are lacking.
Patients were eligible for the randomized, multicenter AMBORA study, if they were newly started on any of the oral anticancer drugs approved in 2001 or later without restriction to certain tumor entities. Patients were randomly assigned to receive either standard of care (control group) or an additional, intensified clinical pharmacological/pharmaceutical care, which included medication management and structured patient counseling, over a period of 12 weeks (intervention group). Primary end points were the number of antitumor drug-related problems (ie, side effects and unresolved medication errors) and patient treatment satisfaction with the oral anticancer therapy after 12 weeks measured with the Treatment Satisfaction Questionnaire for Medication, category convenience.
Two hundred two patients were included. Antitumor drug-related problems were significantly lower in the intervention compared with the control group (3.85 5.81 [mean], < .001). Patient treatment satisfaction was higher in the intervention group (Treatment Satisfaction Questionnaire for Medication, convenience; 91.6 74.4 [mean], < .001). The hazard ratio for the combined end point of severe side effects (Common Terminology Criteria for Adverse Events ≥ 3), treatment discontinuation, unscheduled hospital admission, and death was 0.48 (95% CI, 0.32 to 0.71, < .001) in favor of the intervention group.
Treatment with oral anticancer drugs is associated with a broad range of medication errors and side effects. An intensified clinical pharmacological/pharmaceutical care has considerable, positive effects on the number of medication errors, patient treatment perception, and severe side effects.
口服抗癌药物（如激酶抑制剂）在癌症治疗中发挥着重要作用。然而，口服抗癌药物的用药安全性方面存在着相当大的挑战。目前缺乏关于强化临床药理学/药学护理对患者安全性和患者治疗感受影响的随机、对照、多中心研究。
如果患者新开始使用任何一种在 2001 年或以后批准的口服抗癌药物，且不受特定肿瘤实体的限制，则有资格参加这项随机、多中心的 AMBORA 研究。患者被随机分配接受标准护理（对照组）或额外的强化临床药理学/药学护理，包括药物管理和结构化患者咨询，为期 12 周（干预组）。主要终点是在 12 周后，用药物治疗满意度问卷（Treatment Satisfaction Questionnaire for Medication，category convenience）测量的抗肿瘤药物相关问题（即副作用和未解决的用药错误）的数量和患者对口服抗癌治疗的治疗满意度。
共纳入 202 例患者。与对照组相比，干预组抗肿瘤药物相关问题明显较少（3.85 5.81[平均值]，<.001）。干预组患者的治疗满意度更高（药物治疗满意度问卷，便利性；91.6 74.4[平均值]，<.001）。严重副作用（不良事件通用术语标准≥3）、治疗中断、非计划住院和死亡的联合终点的风险比为 0.48（95%CI，0.32 至 0.71，<.001），有利于干预组。
口服抗癌药物治疗与广泛的用药错误和副作用相关。强化临床药理学/药学护理对用药错误、患者治疗感受和严重副作用的数量具有显著的积极影响。
