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首页> 外文期刊>Annals of oncology: official journal of the European Society for Medical Oncology >Randomized, double-blind, dose-ranging trial of the oral neurokinin-1 receptor antagonist casopitant mesylate for the prevention of cisplatin-induced nausea and vomiting.
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Randomized, double-blind, dose-ranging trial of the oral neurokinin-1 receptor antagonist casopitant mesylate for the prevention of cisplatin-induced nausea and vomiting.

机译：口服神经激肽1受体拮抗剂甲磺酸甲磺酸盐预防顺铂引起的恶心和呕吐的随机，双盲，剂量范围试验。

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BACKGROUND: Casopitant mesylate is a novel, oral neurokinin-1 receptor antagonist with demonstrated antiemetic efficacy. We conducted a randomized, double-blind, controlled phase II trial to evaluate three casopitant doses as part of a triple-therapy regimen for the prevention of nausea and vomiting associated with high-dose cisplatin. The aim of the study was to detect a dose response. PATIENTS AND METHODS: A total of 493 patients with solid tumors receiving a first cycle of cisplatin > or =70 mg/m(2) were randomly assigned among six treatment arms. The primary analysis compared a control arm [ondansetron/dexamethasone (Ond/Dex)] with three investigational treatments (Ond/Dex plus oral casopitant 50, 100, or 150 mg administered daily for 3 days). Two exploratory arms were included: one evaluating a single oral casopitant dose of 150 mg added to standard Ond/Dex and another with 3-day oral aprepitant-based therapy (Ond/Dex plus aprepitant 125 mg day 1, 80 mg days 2-3). RESULTS: The complete response (CR) rate (defined as no vomiting, retching, rescue therapy, or premature discontinuation) was significantly increased in each casopitant arm relative to control over the 120-h evaluation period: 76% (50 mg), 86% (100 mg), 77% (150 mg), and 60% with control (P = 0.0036). The CR rate for the single oral dose regimen was similar to the CR rate reported for the 3-day regimens. No differences were observed in the incidence of nausea or significant nausea among groups in the primary analysis. The most common adverse events related to treatment included headache (n = 10) and hiccups (n = 14). CONCLUSION: All doses of oral casopitant as a 3-day regimen (and likely as a 150-mg single oral dose) in combination with Ond/Dex provided significant improvement in the prevention of cisplatin-induced emesis.
机译：背景：甲磺酸卡西吡坦是一种新型的口服神经激肽-1受体拮抗剂，具有止吐作用。我们进行了一项随机，双盲，对照的II期临床试验，以评估三种casopitant剂量，作为三联疗法预防大剂量顺铂相关的恶心和呕吐的一部分。该研究的目的是检测剂量反应。患者与方法：将总共493例接受第一周期顺铂≥70 mg / m（2）顺铂的实体瘤患者随机分配到六个治疗组中。初步分析比较了对照组[恩丹西酮/地塞米松（Ond / Dex）]和三种研究治疗方法（Ond / Dex加上口服casopitant 50、100或150 mg，每天给药3天）。包括两个试验组：一个评估标准Ond / Dex中单次口服口服casopitant剂量150 mg，另一个评估基于口服阿瑞吡坦的3天疗法（Ond / Dex加阿瑞吡坦125 mg第1天，80 mg第2-3天）。结果：相对于120小时评估期间的对照，每个casopitant手臂的完全缓解（CR）率（定义为无呕吐，呕吐，抢救治疗或过早中断）：76％（50 mg），86分别为（100 mg），77％（150 mg）和60％（P = 0.0036）。单次口服给药方案的CR率与3天方案中报告的CR率相似。在初步分析中，各组之间的恶心或严重恶心的发生率没有差异。与治疗有关的最常见不良事件包括头痛（n = 10）和打ic（n = 14）。结论：所有剂量的口服casopitant 3天方案（可能是150 mg单次口服剂量）与Ond / Dex联用，在预防顺铂引起的呕吐方面有显着改善。

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