Department of Medical Oncology, Lung Cancer and Gastrointestinal Unit, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Changsha, China.
Department of Medical Oncology, Lung Cancer and Gastrointestinal Unit, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Changsha, China; Graduate Schools, University of South China, Hengyang, China.
Clin Lung Cancer. 2018 Nov;19(6):e913-e918. doi: 10.1016/j.cllc.2018.08.006. Epub 2018 Aug 23.
This study aimed to determine the efficacy and safety of aprepitant, palonosetron, and dexamethasone to prevent chemotherapy-induced nausea and vomiting in patients with locally advanced or metastatic lung cancer receiving full-dose single-day cisplatin-based combination chemotherapy.
Patients diagnosed with locally advanced or metastatic lung cancer who received full dose single-day cisplatin-based chemotherapy were randomized (1:1) to aprepitant plus palonosetron and dexamethasone, or placebo plus palonosetron and dexamethasone. The primary endpoint was complete response of nausea and vomiting in the first cycle. The secondary endpoints were the proportion of patients with nausea and vomiting who received rescue antiemetic medication, the response of cross-over patients, and safety.
A total of 244 patients were randomized. There was no difference between the 2 groups regarding personal characteristics. The administration of aprepitant significantly improved the complete response for vomiting in the overall period (92.6% vs. 79.93%; P < .01), but not a nausea-free response (75.4% vs. 71.3%; P > .05) in the first cycle. The percentage of patients who received rescue antiemetic medication was decreased for the aprepitant group (14.8% vs. 37.1%; P < .001). Patients who did not use aprepitant and suffered with nausea and vomiting in cycle 1 were crossed over to the aprepitant group (N = 32), and the rate of nausea and vomiting in cycle 2 was decreased to 37.5% (P < .05) and 25% (P < .05), respectively. There were no drug-related adverse effects.
Aprepitant plus palonosetron and dexamethasone proved to be effective and well-tolerated in preventing chemotherapy-induced nausea and vomiting after administration of full-dose single-day cisplatin-based combination chemotherapy.
本研究旨在确定阿瑞匹坦、帕洛诺司琼和地塞米松预防接受全剂量单日内顺铂为基础的联合化疗的局部晚期或转移性肺癌患者化疗引起的恶心和呕吐的疗效和安全性。
接受全剂量单日内顺铂为基础化疗的局部晚期或转移性肺癌患者，随机（1:1）分为阿瑞匹坦加帕洛诺司琼和地塞米松组或安慰剂加帕洛诺司琼和地塞米松组。主要终点为第一周期恶心和呕吐的完全缓解。次要终点为接受解救性止吐药物治疗的恶心和呕吐患者的比例、交叉患者的反应以及安全性。
共 244 例患者被随机分组。两组患者的个人特征无差异。阿瑞匹坦的应用显著改善了整个周期的呕吐完全缓解率（92.6% vs. 79.93%；P<.01），但第一周期无恶心无反应（75.4% vs. 71.3%；P>.05）。阿瑞匹坦组接受解救性止吐药物治疗的患者比例降低（14.8% vs. 37.1%；P<.001）。在第一周期未使用阿瑞匹坦且出现恶心和呕吐的患者交叉到阿瑞匹坦组（N=32），第二周期的恶心和呕吐发生率分别降低至 37.5%（P<.05）和 25%（P<.05）。无药物相关不良反应。
阿瑞匹坦加帕洛诺司琼和地塞米松在接受全剂量单日内顺铂为基础的联合化疗后，预防化疗引起的恶心和呕吐有效且耐受性良好。
