Predictive performance of population pharmacokinetic models of imatinib in chronic myeloid leukemia patients.

IF 2.7 4区 医学 Q3 ONCOLOGY Cancer Chemotherapy and Pharmacology Pub Date : 2024-07-01 Epub Date: 2024-03-05 DOI:10.1007/s00280-024-04644-w
Jaya Shree Dilli Batcha, Vikram Gota, Saikumar Matcha, Arun Prasath Raju, Mahadev Rao, Karthik S Udupa, Surulivelrajan Mallayasamy
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Abstract

Background and aim: Chronic myeloid leukemia is a myeloproliferative neoplasm associated with the specific chromosomal translocation known as the Philadelphia chromosome. Imatinib is a potent BCR-ABL tyrosine kinase inhibitor, which is approved as the first line therapy for CML patients. There are various population pharmacokinetic studies available in the literature for this population. However, their use in other populations outside of their cohort for the model development has not been evaluated. This study was aimed to perform the predictive performance of the published population pharmacokinetic models for imatinib in CML population and propose a dosing nomogram.

Methods: A systematic review was conducted through PubMed, and WoS databases to identify PopPK models. Clinical data collected in adult CML patients treated with imatinib was used for evaluation of these models. Various prediction-based metrics were used for assessing the bias and precision of PopPK models using individual predictions.

Results: Eight imatinib PopPK model were selected for evaluating the model performance. A total of 145 plasma imatinib samples were collected from 43 adult patients diagnosed with CML and treated with imatinib. The PopPK model reported by Menon et al. had better performance than all other PopPK models.

Conclusion: Menon et al. model was able to predict well for our clinical data where it had the relative mean prediction error percentage ≤ 20%, relative median absolute prediction error ≤ 30% and relative root mean square error close to zero. Based on this final model, we proposed a dosing nomogram for various weight groups, which could potentially help to maintain the trough concentrations in the therapeutic range.

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慢性骨髓性白血病患者服用伊马替尼的群体药代动力学模型的预测性能。
背景和目的:慢性髓性白血病是一种与特定染色体易位(即费城染色体)相关的骨髓增生性肿瘤。伊马替尼是一种强效的 BCR-ABL 酪氨酸激酶抑制剂,已被批准作为慢性骨髓性白血病患者的一线疗法。文献中有各种针对这一人群的药代动力学研究。然而,这些研究在其队列之外的其他人群中用于模型开发的情况尚未得到评估。本研究旨在对已发表的伊马替尼群体药代动力学模型在 CML 群体中的预测性能进行评估,并提出剂量提名图:方法:通过PubMed和WoS数据库进行了系统回顾,以确定PopPK模型。收集的伊马替尼治疗的成年 CML 患者的临床数据用于评估这些模型。使用各种基于预测的指标来评估PopPK模型的偏差和精确度:结果:选择了 8 个伊马替尼 PopPK 模型来评估模型的性能。从43名确诊为慢性骨髓性白血病并接受伊马替尼治疗的成人患者身上共收集了145份伊马替尼血浆样本。Menon等人报告的PopPK模型的性能优于其他所有PopPK模型:Menon等人的模型能够很好地预测我们的临床数据,其相对平均预测误差百分比≤20%,相对中位绝对预测误差≤30%,相对均方根误差接近于零。根据这一最终模型,我们提出了针对不同体重组的剂量提名图,这可能有助于将谷浓度维持在治疗范围内。
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来源期刊
CiteScore
6.10
自引率
3.30%
发文量
116
审稿时长
2.5 months
期刊介绍: Addressing a wide range of pharmacologic and oncologic concerns on both experimental and clinical levels, Cancer Chemotherapy and Pharmacology is an eminent journal in the field. The primary focus in this rapid publication medium is on new anticancer agents, their experimental screening, preclinical toxicology and pharmacology, single and combined drug administration modalities, and clinical phase I, II and III trials. It is essential reading for pharmacologists and oncologists giving results recorded in the following areas: clinical toxicology, pharmacokinetics, pharmacodynamics, drug interactions, and indications for chemotherapy in cancer treatment strategy.
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