PURPOSE We assessed the efficacy of aprepitant (APR) or 10 or 5 mg OLN (OLN10 or OLN5) plus ondansetron and dexamethasone for chemotherapy-induced nausea/vomiting (CINV) prophylaxis in patients receiving high-emetogenic chemotherapy (HEC). METHODS Patients who received doxorubicin + cyclophosphamide or cisplatin were given intravenous ondansetron and dexamethasone prior to chemotherapy and oral dexamethasone on days 2-4 and randomized 1:1:1 to receive APR125 on day 1 and APR80 on days 2-3 or OLN10 or OLN5 on days 1-4. Matched placebo controls were used. The primary endpoint was no nausea in ≤ 120 h. Secondary endpoints included CINV severity, complete response (CR) rate, adverse effects (AE), and quality of life. RESULTS Of 141 patients, 104 received AC and 37 received cisplatin. The no-nausea rates were 33% (APR), 43.2% (OLN10; p = 0.24), and 37% (OLN5; p = 0.87). Grades 2-4 nausea were experienced by fewer patients for OLN10 than for APR (24-120 h, 8.7% vs. 27.7%, respectively; p = 0.02; overall period, 19.6% vs. 40.4%, respectively; p = 0.03). The median visual analog scale nausea score from 24 to 120 h was significantly lower for OLN10 (2.3) than for APR (1.2, p = 0.03). The degrees of vomiting, CR, and AE were similar between the APR and OLN10 groups. CINV was similar between the OLN5 and APR groups. CONCLUSIONS Nausea was less severe for OLN10 than for APR in patients receiving HEC, but other measures were similar. CINV prevention efficacy was comparable between OLN5 and APR.

中文翻译：

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随机，双盲，安慰剂对照研究对奥氮平与奥氮平联合恩丹西酮加地塞米松的两种剂量预防接受高致呕吐化疗的化疗引起的恶心和呕吐。

目的我们评估了先天性（APR）或10或5毫克OLN（OLN10或OLN5）加上恩丹西酮和地塞米松对接受高促发性化疗（HEC）的化疗引起的恶心/呕吐（CINV）预防的功效。方法接受阿霉素+环磷酰胺或顺铂治疗的患者在化疗前静脉给予恩丹西酮和地塞米松，第2-4天口服地塞米松，第1天随机接受1：1的APR125治疗，第2-3天接受APR80的治疗，第2-3天接受OLN10或OLN5接受在第1-4天。使用匹配的安慰剂对照。主要终点在≤120小时内没有恶心。次要终点包括CINV严重程度，完全缓解（CR）率，不良反应（AE）和生活质量。结果在141例患者中，有104例接受了AC，37例接受了顺铂。无恶心率为33％（APR），43.2％（OLN10； p = 0.24），和37％（OLN5； p = 0.87）。OLN10患者经历的2-4级恶心少于APR（24-120小时，分别为8.7％和27.7％; p = 0.02;整个时期分别为19.6％和40.4％; p = 0.03） 。OLN10（2.3）的中位视觉模拟评分恶心评分从24到120 h显着低于APR（1.2，p = 0.03）。APR组和OLN10组之间的呕吐程度，CR和AE相似。OLN5和APR组之间的CINV相似。结论接受HEC的患者中，OLN10的恶心程度不及APR，但其他措施相似。CINV预防功效在OLN5和APR之间相当。OLN10（2.3）的中位视觉模拟评分恶心评分从24到120 h显着低于APR（1.2，p = 0.03）。APR和OLN10组之间的呕吐程度，CR和AE相似。OLN5和APR组之间的CINV相似。结论接受HEC的患者中，OLN10的恶心程度不及APR，但其他措施相似。CINV预防功效在OLN5和APR之间相当。OLN10（2.3）的中位视觉模拟评分恶心评分从24到120 h显着低于APR（1.2，p = 0.03）。APR组和OLN10组之间的呕吐程度，CR和AE相似。OLN5和APR组之间的CINV相似。结论接受HEC的患者中，OLN10的恶心程度不及APR，但其他措施相似。CINV预防功效在OLN5和APR之间相当。