Levêque Dominique
Pharmacy, Hôpital de Hautepierre and Pharmacy, Institut de Cancérologie Strasbourg Europe (ICANS), Avenue Molière, 67000 Strasbourg, France.
Pharmaceuticals (Basel). 2025 Jun 6;18(6):848. doi: 10.3390/ph18060848.
Beyond developing new agents, cancer treatment can also be optimized by modifying the dosing regimen of approved drugs. Academic teams have experimented with different ways of improving drug regimens, leading to off-label practices for therapeutic and/or economic purposes, and currently, drug regulatory agencies have begun to reappraise this often-neglected topic. This concept also considers the patient's perspective in terms of quality of life and convenience, including the concept of time toxicity. Overall, the optimization of drug dosing of anticancer agents may be viewed on three sides: the improvement of the benefits/risks balance (patient), the improvement of the convenience of the treatment (patient, healthcare professionals), and the mitigation of the financial impact (health insurance, patient). Examples of dose reassessments of targeted therapies (approved since 1997) are chosen to illustrate the context. Suboptimal/overdosed regimens are found for certain molecularly targeted agents, mostly based on the ancient concept of maximum tolerated dose in oncology. This underlines the lack of comparative effective dose trials before approval. Fortunately, dosing regimens of newly approved molecularly targeted agents is going to evolve with the hope of more convenient and better tolerated treatments. This optimization will bring greater benefit to patients and to healthcare professionals but without addressing the economic issue.
除了研发新药物,癌症治疗还可以通过调整已获批药物的给药方案来优化。学术团队已经尝试了不同的方法来改进药物方案,出于治疗和/或经济目的导致了超说明书用药行为,目前,药品监管机构已开始重新审视这个经常被忽视的话题。这一概念还从生活质量和便利性的角度考虑了患者的观点,包括时间毒性的概念。总体而言,抗癌药物给药方案的优化可以从三个方面来看待:改善获益/风险平衡(患者)、提高治疗便利性(患者、医护人员)以及减轻经济影响(医疗保险、患者)。选择靶向治疗(自1997年获批以来)剂量重新评估的例子来说明相关情况。发现某些分子靶向药物存在次优/过量给药方案,主要基于肿瘤学中古老的最大耐受剂量概念。这凸显了获批前缺乏比较有效剂量试验的问题。幸运的是,新获批分子靶向药物的给药方案将会不断演变,有望实现更便利且耐受性更好的治疗。这种优化将给患者和医护人员带来更大益处,但未涉及经济问题。