Loh Gabriel W, Ting Lillian S L, Ensom Mary H H
Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, British Columbia, Canada.
Clin Pharmacokinet. 2007;46(6):471-94. doi: 10.2165/00003088-200746060-00002.
Despite evidence in the literature suggesting that a strong correlation exists between the pharmacokinetic parameters and pharmacodynamic effect of anticancer agents, many of these agents are still dosed by body surface area. Therapeutic drug monitoring with the aim of pharmacokinetic-guided dosing would not only maintain target concentrations associated with efficacy but may potentially minimise the likelihood of dose-related systemic toxicities. The pharmacokinetic parameter that displays the best correlation with the pharmacodynamics of anticancer drugs is the area under the plasma concentration-time curve (AUC). However, accurate determination of the AUC requires numerous blood samples over an extended interval, which is not feasible in clinical practice. Therefore, limited sampling strategies (LSSs) have been proposed as a means to accurately and precisely estimate pharmacokinetic parameters with a minimal number of blood samples. LSSs have been developed for many drugs, particularly ciclosporin and other immunosuppressants, as well as for certain anticancer drugs. This systematic review evaluates LSSs developed for the platinum compounds and categorises 18 pertinent citations according to criteria adapted from the US Preventive Services Task Force. Thirteen citations (four level I, six level II-1, three level II-2) pertained to LSSs for carboplatin, four citations (one level II-1, one level II-2, two level III) to cisplatin LSSs, and one citation (level II-2) to nedaplatin. Based on the current evidence, it appears that LSSs may be useful for pharmacokinetic-guided dosage adjustments of carboplatin in both adults and children with cancer. Although some validation studies suggest that LSSs can be extended to different cancer populations or different chemotherapy regimens, other studies dispute this finding. Although the use of LSSs to predict the pharmacokinetic parameters of cisplatin and nedaplatin appear promising, the quality of evidence from published studies does not support routine implementation at this time.LSSs represent one approach in which clinicians can make specific dosage adjustments for individual patients to optimise outcomes. However, the limitations of these strategies must also be taken into consideration. There is also a need for prospective studies to demonstrate that application of LSSs for platinum agents ultimately improves patient response and decreases systemic toxicities.
尽管文献中的证据表明抗癌药物的药代动力学参数与药效学效应之间存在很强的相关性,但这些药物中的许多仍按体表面积给药。旨在进行药代动力学指导给药的治疗药物监测不仅能维持与疗效相关的目标浓度,还可能潜在地降低剂量相关全身毒性的可能性。与抗癌药物药效学显示最佳相关性的药代动力学参数是血浆浓度-时间曲线下面积(AUC)。然而,准确测定AUC需要在较长时间内采集大量血样,这在临床实践中并不可行。因此,已提出有限采样策略(LSS)作为用最少数量的血样准确且精确地估算药代动力学参数的一种方法。已针对许多药物开发了LSS,特别是环孢素和其他免疫抑制剂,以及某些抗癌药物。本系统评价评估了为铂类化合物开发的LSS,并根据美国预防服务工作组采用的标准对18篇相关文献进行了分类。13篇文献(4篇I级、6篇II-1级、3篇II-2级)涉及卡铂的LSS,4篇文献(1篇II-1级、1篇II-2级、2篇III级)涉及顺铂LSS,1篇文献(II-2级)涉及奈达铂。基于目前的证据,LSS似乎可用于对患有癌症的成人和儿童进行卡铂的药代动力学指导剂量调整。尽管一些验证研究表明LSS可扩展到不同的癌症人群或不同的化疗方案,但其他研究对此发现提出质疑。尽管使用LSS预测顺铂和奈达铂的药代动力学参数似乎很有前景,但已发表研究的证据质量目前不支持常规实施。LSS是临床医生可以针对个体患者进行特定剂量调整以优化治疗结果的一种方法。然而,也必须考虑这些策略的局限性。还需要进行前瞻性研究,以证明将LSS应用于铂类药物最终可改善患者反应并降低全身毒性。