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首页> 外文期刊>Annals of oncology: official journal of the European Society for Medical Oncology >Double-blind, randomised, controlled study of the efficacy and tolerability of palonosetron plus dexamethasone for 1 day with or without dexamethasone on days 2 and 3 in the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy.
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Double-blind, randomised, controlled study of the efficacy and tolerability of palonosetron plus dexamethasone for 1 day with or without dexamethasone on days 2 and 3 in the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy.

机译：帕洛诺司琼联合地塞米松在有或无地塞米松治疗的第2天和第3天在预防中度致癌化学疗法引起的恶心和呕吐方面的疗效和耐受性的双盲，随机对照研究。

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BACKGROUND: To reduce side-effects of corticosteroid-containing antiemetic regimens, tailoring antiemetic schedules to specific requirements of different patients could be of benefit. We evaluated the possibility to reduce the total dose of corticosteroids when palonosetron, a long-acting second-generation 5-hydroxytryptamine-3 (5-HT(3)) receptor antagonist, is used. MATERIALS AND METHODS: Double-blind, multicentre, noninferiority study of chemotherapy-naive breast cancer patients receiving 0.25 mg palonosetron and 8 mg dexamethasone on day 1, randomly assigned to receive placebo (n = 151) or 4 mg b.i.d. dexamethasone (n = 149) on days 2 and 3. Primary end point was complete response (CR) rate (no emesis, no rescue medication) in the overall (days 1-5) period. Secondary end points were CR rates in the acute (day 1) and delayed (days 2-5) periods, rates of no emesis and no nausea and impact on daily functioning (Functional Living Index-Emesis). RESULTS: Noninferiority between the two treatments was demonstrated by similar CR rates (P = 0.487) in the overall period. Most parameters showed that palonosetron and dexamethasone on day 1 only offer chemotherapy-induced nausea and vomiting protection similar to multiple-day dexamethasone administration. CONCLUSION: In patients treated with a single injection of palonosetron on day 1, reducing dexamethasone is an option that is not associated with significant reduction in antiemetic control during the 5-day period or an impact on patient functioning.
机译：背景：为减少含皮质类固醇止吐方案的副作用，针对不同患者的具体需求量身定制止吐方案可能会有所帮助。我们评估了使用帕洛诺司琼（长效的第二代5-羟基色胺3（5-HT（3））受体拮抗剂）时降低皮质类固醇总剂量的可能性。材料与方法：未经化疗的初治乳腺癌患者在第1天接受0.25 mg帕洛诺司琼和8 mg地塞米松的双盲，多中心，非劣效性研究，随机分配接受安慰剂（n = 151）或4 mg b.i.d.在第2天和第3天使用地塞米松（n = 149）。主要终点是整个（1-5天）期间的完全缓解（CR）率（无呕吐，无急救药物）。次要终点是急性期（第1天）和延迟期（第2-5天）的CR率，无呕吐，无恶心的率以及对日常功能的影响（功能性生活指数-呕吐）。结果：在整个治疗期间，两种治疗方法的非劣效性均以相似的CR率证实（P = 0.487）。大多数参数表明，帕洛诺司琼和地塞米松在第1天仅提供化学疗法诱导的恶心和呕吐保护，与多日地塞米松给药相似。结论：在第1天单次注射帕洛诺司琼治疗的患者中，减少地塞米松的选择与5天期间止吐药控制量的显着降低或对患者功能的影响无关。

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