Optimization of cancer chemotherapy on the basis of pharmacokinetics and pharmacodynamics: from patients enrolled in clinical trials to those in the 'real world'.
Optimization of cancer chemotherapy on the basis of pharmacokinetics and pharmacodynamics: from patients enrolled in clinical trials to those in the 'real world'.
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基于药代动力学和药效学优化癌症化疗：从参加临床试验的患者到“现实世界”中的患者。
DOI：
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发表时间：
2014
影响因子：
2.1
通讯作者：
Y. Sasaki
中科院分区：
文献类型：
--
作者：
Ken;Y. Sasaki
细胞毒性抗癌药物是所有药物中最具挑战性的治疗药物，其疗效相对较窄。因此，医学肿瘤学家必须切实管理严重毒性作用的风险，以优化治疗结果。细胞毒性抗癌药的剂量和治疗方案建议是根据临床试验确定的。参加临床试验的患者是那些可能在临床实践中接受药物治疗的患者，不包括那些患有器官功能障碍、肥胖、高龄或合并症等疾病的患者。另一方面，“真实的世界”包括大量不符合临床试验合格标准的此类患者。然而，缺乏足够有力的药代动力学和药效学研究的数据来支持此类患者的剂量建议。因此，在这些受试者中化疗的剂量水平和治疗时间表有些随意，没有证据。需要在“真实的世界”中对患者进行药代动力学和药效学研究来解决这个问题。在这篇综述文章中，我们描述了入组临床试验的癌症患者和“真实的世界”癌症患者的临床药理学的一般方面，并介绍了关于伊立替康和S-1在“真实的世界”癌症患者中的药代动力学和药效学特性的最新发现。
Cytotoxic anticancer drugs are the most challenging therapeutic agents among all medicines with relatively narrow efficacy profiles. Therefore, medical oncologists have to practically manage the risk of severe toxic effects to optimize treatment outcomes. Dose and treatment-schedule recommendations for cytotoxic anticancer agents are determined on the basis of clinical trials. Patients enrolled in clinical trials are those likely to receive the drug in clinical practice, excluding those with conditions such as organ dysfunction, obesity, advanced age, or comorbidity. On the other hand, the 'real world' includes large numbers of such patients who do not meet the eligibility criteria of clinical trials. However, there is a paucity of data from sufficiently powered pharmacokinetic and pharmacodynamic studies to support dosage recommendations in such patients. Consequently, dose levels and treatment schedules for chemotherapy in these subjects are somewhat arbitrary and not evidence-based. Pharmacokinetic and pharmacodynamic studies of patients in the 'real world' are needed to address this issue. In this review article, we describe general aspects of clinical pharmacology in cancer patients enrolled in clinical trials and those in the 'real world,' and introduce recent findings regarding the pharmacokinetic and pharmacodynamic properties of irinotecan and S-1 in 'real world' cancer patients.
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DOI：
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发表时间：
1994-07
期刊：
The Journal of pharmacology and experimental therapeutics
影响因子：
--
作者：
T. Shimada;H. Yamazaki;M. Mimura;Y. Inui;F. Guengerich
通讯作者：
T. Shimada;H. Yamazaki;M. Mimura;Y. Inui;F. Guengerich
影响因子：
158.5
作者：
BRENNER, BM;MEYER, TW;HOSTETTER, TH
通讯作者：
HOSTETTER, TH
DOI：
10.1073/pnas.95.14.8170
发表时间：
1998-07-07
影响因子：
11.1
作者：
Beutler, E;Gelbart, T;Demina, A
通讯作者：
Demina, A
影响因子：
45.3
作者：
GIANNI, L;KEARNS, CM;EGORIN, MJ
通讯作者：
EGORIN, MJ
大鼠肝脏二氢胸腺嘧啶脱氢酶的纯化和性质。
DOI：
--
发表时间：
1981
期刊：
The Journal of biological chemistry
影响因子：
--
作者：
Shiotani,T;Weber,G
通讯作者：
Weber,G