固定剂量给药在抗肿瘤单抗药物中的选择和应用

Dosage regimen selection and application for monoclonal antibody in oncology

肿瘤药物的剂量方案通常是基于身体大小(如体表面积和体重)给药,以减小临床结果的个体间差异。然而,许多肿瘤单克隆抗体类药物具有明确靶点、较宽治疗窗,且身体大小对于对药代动力学特征的个体间变异的贡献并不大。因此,选择固定剂量方案还是基于身体大小的剂量方式就值得商榷。本文总结了不同肿瘤单克隆抗体药物的剂量方案,提出了基于药代动力学和药效学的剂量选择策略。

Dosage regimens for oncology drugs are typically based on body size(eg,body surface area,body weight)to reduce inter-individual differences in clinical outcomes.However,many anti-tumor monoclonal antibody drugs have specific targets,wide therapeutic window,and the body size does not always contribute much to the inter-individual variation in pharmacokinetics.Hence it is difficult to make decision on the selection of fixed-dosing or body sized-based dosing.This paper summarizes the dosing regimen of different monoclonal antibodies in oncology,and proposes a dose selection strategy based on pharmacokinetics and pharmacodynamics.