Fang Wu1, Xiaoping Lin1, Zhanghuan Yang2, Ziyi Sun1, Fanxu Zeng1, Jianfu Heng1, Jingjing Qu1, Liang Zeng1, Nong Yang3, Yongchang Zhang4. 1. Department of Medical Oncology, Lung Cancer and Gastrointestinal Unit, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Changsha, China. 2. 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. 3. Department of Medical Oncology, Lung Cancer and Gastrointestinal Unit, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Changsha, China. Electronic address: yangnong0217@163.com. 4. Department of Medical Oncology, Lung Cancer and Gastrointestinal Unit, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Changsha, China. Electronic address: zhangyongchang@csu.edu.cn.
Abstract
INTRODUCTION: 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-daycisplatin-based combination chemotherapy. MATERIALS AND METHODS:Patients diagnosed with locally advanced or metastatic lung cancer who receivedfull 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. RESULTS: 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. CONCLUSIONS: 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.
RCT Entities:
INTRODUCTION: 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. MATERIALS AND METHODS: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. RESULTS: 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. CONCLUSIONS: 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.
Authors: Jin Hyoung Kang; Jung Hye Kwon; Yun-Gyoo Lee; Keon Uk Park; Ho Jung An; Joohyuk Sohn; Young Mi Seol; Hyunwoo Lee; Hwan-Jung Yun; Jin Seok Ahn; Ji Hyun Yang; Hunho Song; Dong-Hoe Koo; Jin Young Kim; Gun Min Kim; Hwa Jung Kim Journal: Cancer Res Treat Date: 2020-03-18 Impact factor: 4.679