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Dose-banding of carboplatin: rationale and proposed banding scheme.

机译:卡铂剂量分带:基本原理和建议的分带方案。

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摘要

BACKGROUND: In dose-banding (DB) prescribed doses of cancer chemotherapy are fitted to doseranges or 'bands' and standard doses for each band are provided using a selection of pre-filled infusions or syringes, either singly or in combination. DB is used for several drugs where dose is based on body surface area. No DB-scheme has been reported for carboplatin, which, in clinical practice, is routinely dosed according to renal function. STUDY OBJECTIVE: To assess the rationale for DB of carboplatin with regards to factors that influence dosing accuracy, develop a DB scheme, and discuss its potential use and limitations. METHODS: Prospective evaluations of carboplatin area under the plasma concentration -- time curve (AUC) following application of the Calvert-formula were identified by a literature search. A relevant carboplatin dose range for construction of a DB-scheme with Calvert-formula based doses was obtained from published glomerular filtration rate distributions for patients receiving carboplatin. RESULTS: A DB-scheme was developed for individually calculated carboplatin doses of 358-1232 mg, with 35 mg increments between each standard dose and a maximum deviation of 4.7% from prescribed dose. The proposed DB-scheme covers the GFR-ranges 47-221 mL/min and 26-151 mL/min for patients receiving doses based on the target AUCs of 5 and 7 mg/mL/min, respectively. CONCLUSION: There is a strong scientific rationale to support DB of carboplatin. The proposed banding scheme could introduce benefits to patients and healthcare staff but, as with other DB schemes, should be validated with prospective clinical and pharmacokinetic studies to confirm safety and efficacy.
机译:背景:在剂量范围(DB)中,将癌症化学疗法的处方剂量调整为剂量范围或“范围”,并使用预先填充的输注液或注射器(单独或组合使用)为每个范围提供标准剂量。 DB用于几种药物,剂量取决于体表面积。没有关于卡铂的DB方案的报道,在临床实践中,卡铂通常根据肾功能进行常规给药。研究目的:就影响剂量准确性的因素,评估卡铂DB的基本原理,开发DB方案,并讨论其潜在用途和局限性。方法:通过文献检索确定了在应用Calvert公式后血浆浓度-时间曲线(AUC)下卡铂面积的前瞻性评估。从已发表的接受卡铂患者的肾小球滤过率分布中获得用于构建基于Calvert公式剂量的DB方案的相关卡铂剂量范围。结果:开发了一种DB方案,用于单独计算的358-1232 mg卡铂剂量,每个标准剂量之间递增35 mg,与规定剂量的最大偏差为4.7%。对于接受剂量分别为5和7 mg / mL / min的目标AUC的患者,建议的DB方案涵盖了GFR范围47-221 mL / min和26-151 mL / min。结论:支持卡铂数据库有很强的科学依据。提议的分级方案可能会给患者和医护人员带来好处,但与其他DB方案一样,应通过前瞻性临床和药代动力学研究进行验证,以确认安全性和有效性。

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