TDM-Based Tailored Dosing of Durvalumab in Lung Cancer Patients: A Comprehensive Population Pharmacokinetic-Pharmacoeconomic Evaluation.

IF 4.6 2区医学 Q1 PHARMACOLOGY & PHARMACY

Clinical Pharmacokinetics Pub Date : 2025-07-25 DOI:10.1007/s40262-025-01555-8

Fenna de Vries, Eric J F Franssen, Arthur A J Smit, Dirk Jan A R Moes, Anthonie J van der Wekken, Thijs Oude Munnink, Jeroen J M A Hendrikx, Daphne W Dumoulin, Stijn L W Koolen, Wietske Kievit, Michel M van den Heuvel, Rob Ter Heine

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Abstract

Background: The increasing use of immune checkpoint inhibitors, such as durvalumab, places a significant financial burden on healthcare systems, strains hospital capacities, and contributes to environmental concerns.

Objective: We aimed to develop alternative dosing strategies to optimize durvalumab administration, reduce unnecessary drug use, and ensure sustainable cancer care without sacrificing efficacy.

Methods: Using the population pharmacokinetic model developed by the licensing holder, we designed two alternative dosing strategies for non-small cell lung cancer based on therapeutic drug monitoring. Adjustments were made to the dose or administration interval, following regulatory standards for in silico dose optimization. A pharmacoeconomic evaluation was conducted to estimate potential cost savings from a medical perspective.

Results: Both alternative strategies achieved high exposure levels, with 98.1-99.0% of patients exceeding a predefined efficacy target, surpassing the 95.4% predicted by the license holder for the approved 10 mg/kg 2-weekly regimen. They also reduced overall drug exposure by 7-24% and eliminated drug wastage, resulting in an average annual cost reduction of €25,163 (22.9%) per patient.

Conclusion: Therapeutic drug monitoring-guided adjustments for durvalumab offer a potentially cost-saving way to optimize drug use, reduce healthcare burdens, and lessen environmental impact while ensuring adequate patient exposure. Our proposal's evidence provides a solid basis for a non-inferiority study.

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肺癌患者基于tdm的Durvalumab量身定制剂量：综合人群药代动力学-药物经济学评价。

背景：越来越多地使用免疫检查点抑制剂，如杜伐单抗，给医疗保健系统带来了巨大的经济负担，使医院能力紧张，并导致环境问题。目的：我们旨在开发替代给药策略，以优化durvalumab给药，减少不必要的药物使用，并在不牺牲疗效的情况下确保可持续的癌症治疗。方法：利用许可持有人开发的人群药代动力学模型，基于治疗药物监测设计了两种非小细胞肺癌的替代给药策略。调整剂量或给药间隔，遵循硅剂量优化的监管标准。进行了药物经济学评估，以估计从医学角度节省的潜在费用。结果：两种替代策略都达到了高暴露水平，98.1-99.0%的患者超过了预定的疗效目标，超过了许可持有人对批准的10 mg/kg 2周方案预测的95.4%。他们还减少了7-24%的总体药物暴露，消除了药物浪费，导致每位患者平均每年成本降低25163欧元（22.9%）。结论：治疗药物监测引导的durvalumab调整提供了一种潜在的节省成本的方法来优化药物使用，减轻医疗负担，减少环境影响，同时确保充分的患者暴露。我们提出的证据为非劣效性研究提供了坚实的基础。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Pharmacokinetics 医学-药学

CiteScore

8.80

自引率

4.40%

发文量

审稿时长

6-12 weeks

期刊介绍： Clinical Pharmacokinetics promotes the continuing development of clinical pharmacokinetics and pharmacodynamics for the improvement of drug therapy, and for furthering postgraduate education in clinical pharmacology and therapeutics. Pharmacokinetics, the study of drug disposition in the body, is an integral part of drug development and rational use. Knowledge and application of pharmacokinetic principles leads to accelerated drug development, cost effective drug use and a reduced frequency of adverse effects and drug interactions.