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一项评估阿瑞匹坦对血液系统恶性肿瘤中高度/中度致吐性化疗疗效的随机对照研究。

A randomized controlled study evaluating the efficacy of aprepitant for highly/moderately emetogenic chemotherapies in hematological malignancies.

作者信息

Nasu R, Nannya Y, Kurokawa M

机构信息

Department of Hematology and Oncology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.

出版信息

Int J Hematol. 2015 Apr;101(4):376-85. doi: 10.1007/s12185-015-1735-y. Epub 2015 Feb 3.

DOI:10.1007/s12185-015-1735-y
PMID:25644148
Abstract

Chemotherapy-induced nausea and vomiting (CINV) is a serious complication of treatments of hematological malignancies. Although aprepitant, an NK1 receptor antagonist, has been shown to control CINV in highly emetogenic therapies for solid tumors, the antiemetic effect of this agent in hematological chemotherapies is not well established. In this randomized controlled trial, we examined the additional effect of aprepitant in combination with conventional 5HT3 blocker-based prophylaxis for CINV in highly or moderately emetic chemotherapies for hematological malignancies (n = 41). The complete response rate, defined as no emetic episodes and no salvage treatments, was significantly higher in the aprepitant arm than the control arm (82 versus 47 %, p = 0.026), with no increase in severe adverse effects. However, the difference of nausea, measured with visual analog scale, and of oral intake impairment was moderate, which suggests insufficiency of blocking NK receptor for these events. Furthermore, sub-group analysis revealed that merit of aprepitant addition depends on treatment regimens. Our results indicate the overall advantage of applying aprepitant in the control of CINV in hematological malignancies and the need for further refinement of anti-CINV strategies, including stratification according to regimen.

摘要

化疗引起的恶心和呕吐(CINV)是血液系统恶性肿瘤治疗中的一种严重并发症。尽管阿瑞匹坦(一种NK1受体拮抗剂)已被证明在实体瘤的高致吐性治疗中可控制CINV,但该药物在血液学化疗中的止吐效果尚未明确。在这项随机对照试验中,我们研究了阿瑞匹坦联合传统的基于5HT3阻滞剂的预防方案,用于血液系统恶性肿瘤的高致吐或中度致吐化疗中控制CINV的附加效果(n = 41)。完全缓解率定义为无呕吐发作且无需挽救治疗,阿瑞匹坦组显著高于对照组(82%对47%,p = 0.026),且严重不良反应未增加。然而,用视觉模拟量表测量的恶心差异以及口服摄入受损情况差异中等,这表明阻断NK受体对这些事件的作用不足。此外,亚组分析显示,添加阿瑞匹坦的益处取决于治疗方案。我们的结果表明,应用阿瑞匹坦控制血液系统恶性肿瘤中的CINV具有总体优势,并且需要进一步完善抗CINV策略,包括根据方案进行分层。

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A phase II open-label study of aprepitant as anti-emetic prophylaxis in patients with acute myeloid leukemia (AML) undergoing induction chemotherapy.
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