A phase III, double-blind, randomized trial of palonosetron compared with ondansetron in preventing chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy
A phase III, double-blind, randomized trial of palonosetron compared with ondansetron in preventing chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy
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DOI：
10.1093/annonc/mdl137
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发表时间：
2006-09-01
影响因子：
50.5
通讯作者：
Macciocchi, A.
中科院分区：
文献类型：
--
作者：
Aapro, M. S.;Grunberg, S. M.;Macciocchi, A.
背景资料：这个关键的III期临床试验评价帕洛诺司琼在预防急性和迟发性化疗引起的恶心和呕吐（CINV）后高度致吐化疗（HEC）的疗效和安全性。患者和方法：患者被随机分配到一个单一的静脉注射剂量帕洛诺司琼0.25毫克或0.75毫克，或昂丹司琼32毫克前HEC。地塞米松预治疗（分层）由研究者酌情决定。主要疗效终点为化疗后前24小时内完全缓解（CR）的患者比例结果：在意向治疗分析（n = 667）中，帕洛诺司琼0.25 mg和0.75 mg在预防急性CINV方面至少与昂丹司琼一样有效（CR率分别为59.2%、65.5%和57.0%）;在延迟（24-120 h）和总体（0-120 h）阶段，帕洛诺司琼的CR率略高于昂丹司琼。三分之二的患者（n = 447）合并使用地塞米松。在延迟期（42.0% vs 28.6%）和总体期（40.7% vs 25.2%），接受帕洛诺司琼0.25 mg+地塞米松预治疗的患者的CR率显著高于接受昂丹司琼+地塞米松的患者。帕洛诺司琼和昂丹司琼耐受良好。结论：单剂量帕洛诺司琼是有效的昂丹司琼在预防急性CINV后HEC，地塞米松预处理，其有效性显着增加昂丹司琼在整个5天化疗后期间。
Background: This pivotal phase III trial evaluated the efficacy and safety of palonosetron in preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV) following highly emetogenic chemotherapy (HEC).Patients and methods: Patients were randomized to a single intravenous dose of palonosetron 0.25 mg or 0.75 mg, or ondansetron 32 mg prior to HEC. Dexamethasone pre-treatment (with stratification) was used at investigator discretion. The primary efficacy endpoint was the proportion of patients with complete response (CR) during the first 24 h post-chemotherapy (acute phase).Results: In the intent-to-treat analysis (n = 667), palonosetron 0.25 mg and 0.75 mg were at least as effective as ondansetron in preventing acute CINV (59.2%, 65.5%, and 57.0% CR rates, respectively); CR rates were slightly higher with palonosetron than ondansetron during the delayed (24-120 h) and overall (0-120 h) phases. Two thirds of patients (n = 447) received concomitant dexamethasone. Patients pre-treated with palonosetron 0.25 mg plus dexamethasone had significantly higher CR rates than those receiving ondansetron plus dexamethasone during the delayed (42.0% versus 28.6%) and overall (40.7% versus 25.2%) phases. Palonosetron and ondansetron were well tolerated.Conclusions: Single-dose palonosetron was as effective as ondansetron in preventing acute CINV following HEC, and with dexamethasone pre-treatment, its effectiveness was significantly increased over ondansetron throughout the 5-day post-chemotherapy period.