OBJECTIVE To evaluate the efficacy and safety of the addition of olanzapine to ondansetron and dexamethasone for chemotherapy-induced nausea vomiting (CINV) prevention in patients receiving highly emetogenic chemotherapy (HEC). METHODS In this randomized, double-blind, placebo-controlled, crossover study, we randomly assigned chemotherapy-naïve patients receiving HEC to receive olanzapine or placebo in addition to ondansetron and dexamethasone. All subjects were crossed over to another treatment arm on second-cycle chemotherapy. The primary endpoint was complete response (CR) rate defined as no vomiting and no use of rescue drugs. RESULTS At the first cycle, there were significantly more patients with CR in the olanzapine group than in the placebo group in overall phase (68.7% vs. 25.0%, p < 0.001), acute phase (0-24 h) (75.0% vs. 31.2%, p < 0.001) and delayed phase (24-120 h) (68.7% vs. 43.7%, p = 0.038). After crossover, there were significantly more patients with CR in the olanzapine group than in the placebo group in overall phase (67.2% vs. 25.0%, p < 0.001), acute phase (71.9% vs. 32.8%, p < 0.001) and delayed phase (67.2% vs. 37.5%, p < 0.001). In crossover analysis, the olanzapine group had significantly lower mean nausea (1.28 vs. 3.05, p < 0.001) and fatigue (3.5 vs. 4.58, p < 0.001) scores but higher mean appetite (2.5 vs. 1.55, p = 0.003) and sleepiness (3.26 vs. 2.2, p < 0.001) scores. There were no grade 3 and 4 anti-emetic-drug-related toxicities. Mean QT interval changes did not different between two groups (-4.30 vs. -1.86, p = 0.69). CONCLUSION The addition of olanzapine to ondansetron and dexamethasone significantly improved CINV prevention and was safe in patients receiving HEC.

中文翻译：

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在昂丹司琼和地塞米松中添加奥氮平预防高度致呕性化疗患者化疗引起的恶心和呕吐的有效性和安全性。

目的评估在奥丹西酮和地塞米松中添加奥氮平对接受高促发性化疗（HEC）的患者预防化疗引起的恶心呕吐（CINV）的有效性和安全性。方法在这项随机，双盲，安慰剂对照，交叉研究中，我们将未接受过化疗的初次接受HEC的患者随机分配到除奥丹西隆和地塞米松之外，还接受奥氮平或安慰剂治疗。所有受试者均接受第二周期化疗的另一治疗方案。主要终点为完全缓解（CR）率，定义为无呕吐和不使用急救药物。结果在第一个周期中，奥氮平组的CR患者在整个阶段（68.7％vs. 25.0％，p <0.001），急性期（0-24 h）（75.0％vs 。31.2％，p <0.001）和延迟阶段（24-120 h）（68.7％vs. 43.7％，p = 0.038）。分频后，奥氮平组的CR患者在整个阶段（67.2％vs. 25.0％，p <0.001），急性期（71.9％vs. 32.8％，p <0.001）和安慰剂组明显多于安慰剂组。延迟期（67.2％vs. 37.5％，p <0.001）。在交叉分析中，奥氮平组的平均恶心（1.28 vs. 3.05，p <0.001）和疲劳（3.5 vs. 4.58，p <0.001）得分显着降低，但平均食欲较高（2.5 vs. 1.55，p = 0.003），并且嗜睡（3.26 vs. 2.2，p <0.001）得分。没有与止吐药相关的3级和4级毒性。两组之间的平均QT间隔变化无差异（-4.30对-1.86，p = 0.69）。