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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Extrapolation of Adult Efficacy to Pediatric Patients With Chemotherapy-Induced Nausea and Vomiting
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Extrapolation of Adult Efficacy to Pediatric Patients With Chemotherapy-Induced Nausea and Vomiting

机译：对化疗诱导的恶心和呕吐的儿科患者的成人疗效的推断

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摘要

Chemotherapy-induced nausea and vomiting (CINV) is a common treatment-related adverse event that negatively impacts the quality of life of cancer patients. During pediatric drug development, extrapolation of efficacy from adult to pediatric populations is a pathway that can minimize the exposure of children to unnecessary clinical trials, improve efficiency, and increase the likelihood of success in obtaining a pediatric indication. The acceptability of the use of extrapolation depends on a series of evidence-based assumptions regarding the similarity of disease, response to intervention, and exposure-response relationships between adult and pediatric patients. This study evaluated publicly available summaries of data submitted to the US Food and Drug Administration for drugs approved for CINV to assess the feasibility of extrapolation for future development programs. Extracted data included trial design, emetogenic potential of chemotherapy, primary end points, participant enrollment criteria,and antiemetic pharmacokinetics. Adult and pediatric clinical trial designs for assessment of efficacy and safety shared key design elements. Antiemetic drugs found to be efficacious in adults were also efficacious in pediatric patients.Systemic drug concentrations at approved doses were similar for ondansetron,granisetron,and aprepitant, but an exposure-response analysis of palonosetron in children suggested that higher palonosetron systemic exposure is necessary for the prevention of CINV in the pediatric population. For 5-hydroxytryptamine-3 and neurokinin-1 receptor antagonist antiemetic drugs, efficacy in adults predicts efficacy in children, supporting the extrapolation of effectiveness of an antiemetic product in children from adequate and well-controlled studies in adult patients with CINV.
机译：化疗引起的恶心呕吐（CINV）是一种常见的治疗相关不良事件，对癌症患者的生活质量产生负面影响。在儿科药物开发过程中，从成人到儿科人群的疗效推断是一种途径，可以最大限度地减少儿童接触不必要的临床试验，提高效率，并增加获得儿科适应症的成功可能性。使用外推的可接受性取决于一系列基于证据的假设，这些假设涉及疾病的相似性、对干预的反应以及成人和儿童患者之间的暴露-反应关系。这项研究评估了向美国食品和药物管理局提交的关于CINV批准药物的公开可用数据摘要，以评估未来开发项目外推的可行性。提取的数据包括试验设计、化疗的催吐潜力、主要终点、参与者登记标准和止吐药代动力学。用于评估疗效和安全性的成人和儿童临床试验设计共享关键设计要素。成人有效的止吐药对儿科患者也有效。在批准剂量下，昂丹司琼、格拉司琼和阿普雷帕坦的全身药物浓度相似，但对儿童帕洛诺司琼的暴露反应分析表明，在儿童人群中预防CINV需要更高的帕洛诺司琼全身暴露。对于5-羟色胺-3和神经激肽-1受体拮抗剂止吐药物，成人的疗效预测儿童的疗效，支持从对成年CINV患者的充分和良好对照研究中推断儿童止吐产品的有效性。

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