Randomized, placebo-controlled, pilot study evaluating aprepitant single dose plus palonosetron and dexamethasone for the prevention of acute and delayed chemotherapy-induced nausea and vomiting
Randomized, placebo-controlled, pilot study evaluating aprepitant single dose plus palonosetron and dexamethasone for the prevention of acute and delayed chemotherapy-induced nausea and vomiting
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DOI：
10.1002/cncr.23364
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发表时间：
2008-05-01
期刊：
影响因子：
6.2
通讯作者：
Song, Juhee
中科院分区：
文献类型：
--
作者：
Herrington, Jon D.;Jaskiewicz, Adam D.;Song, Juhee
背景资料。帕洛诺司琼联合安替比妥预防化疗所致呕吐安全有效。这项先导性研究的目的是确定在接受高度催吐性化疗的患者中，1天和3天化疗在预防急性和延迟性恶心呕吐方面的有效性。方法：这项研究是机构审查委员会批准的，并在研究开始前获得知情同意。这是一项试点、单机构、随机、双盲、安慰剂对照试验，评估了3种不同的治疗方案。所有组均于第1天静脉注射帕洛诺司琼0.25 mg，第1~4天静脉注射地塞米松。A组在第一天口服125毫克，第2-3天口服80毫克。B组在第1天口服安慰剂125毫克，第2-3天服用安慰剂。C组在第1-3天接受安慰剂治疗。主要终点是评估每组中急性和迟发性呕吐患者的比例。结果：75名患者纳入分析。研究开始于3组；然而，一项中期分析显示，C臂出现了不可接受的呕吐事件，这组患者被终止。在呕吐、恶心或突破性止吐药物的使用方面，A组和B组之间没有显著差异。在A组和B组，93%的患者在1-5天内没有呕吐，而C组只有50%。结论从这项针对接受帕洛诺司琼、阿派生和地塞米松进行高度催吐化疗的患者的先导性研究中，单剂阿派瑞安与3天阿普利特显示出类似的疗效。
BACKGROUND. The combination of palonosetron and aprepitant is safe and effective in the prevention of chemotherapy- induced emesis (CIE). The purpose of this pilot study was to ascertain the effectiveness of 1-day versus 3-day aprepitant in the prevention of acute and delayed nausea and vomiting in patients who were receiving highly emetogenic chemotherapy.METHODS. This study was institutional review board-approved and informed consent was obtained before this study was begun. This was a pilot, single-institution, randomized, double-blind, placebo-controlled trial that evaluated 3 different treatment arms. All groups received palonosetron 0.25 mg intravenously on Day I and dexamethasone on Days 1-4. Arm A received aprepitant 125 mg orally on Day I followed by 80 mg on Days 2-3. Arm B received aprepitant 125 mg orally on Day I and placebo on Days 2-3. Arm C received placebos on Days 1-3. The primary endpoint was to evaluate the proportion of patients with acute and delaved emesis within each group.RESULTS. Seventy-five patients were included in the analysis. The study commenced with 3 groups; however, an interim analysis displayed unacceptable emesis events in Arm C, and this group was terminated. There were no significant differences between Arms A and B for emesis, nausea, or the use of breakthrough antiemetics. In Arms A and B, 93% of patients were emesis-free from Days 1-5 compared with only 50% in Arm C.CONCLUSIONS. From this pilot study of patients who were receiving palonosetron, aprepitant, and dexamethasone for highly emetogenic chemotherapy, a single dose of aprepitant displayed similar effectiveness compared with 3-day aprepitant.