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Aprepitant triple therapy for the prevention of chemotherapy-induced nausea and vomiting following high-dose cisplatin in Chinese patients: a randomized,double-blind,placebo-controlled phase III trial
Authors:Zhihuang Hu  Ying Cheng  Hongyu Zhang  Caicun Zhou  Baohui Han  Yiping Zhang  Cheng Huang  Jianhua Chang  Xiangqun Song  Jun Liang  Houjie Liang  Chunxue Bai  Shiying Yu  Jia Chen  Jie Wang  Hongming Pan  Denesh K. Chitkara  Darcy A. Hille  Li Zhang
Affiliation:1. Department of Medical Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, 510060, People’s Republic of China
2. State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, 510060, People’s Republic of China
3. The first Department of Internal Medicine, Jilin Province Cancer Hospital, Changchun, People’s Republic of China
4. Department of Oncology, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, People’s Republic of China
5. Cancer Institute, Department of Oncology, Shanghai Pulmonary Hospital, Medical School, Tongji University, 507 Zhengmin Road, Shanghai, 200433, People’s Republic of China
6. Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, 200030, People’s Republic of China
7. Department of Chemotherapy, Zhejiang Cancer Hospital, Hangzhou, 310022, People’s Republic of China
8. Department of Medical Oncology, Fujian Provincial Cancer Hospital, The Teaching Hospital of Fujian Medical University, Fuzhou, People’s Republic of China
9. Department of Medical Oncology, Fudan University Shanghai Cancer Center, 270 Dongan Road, Shanghai, 200032, People’s Republic of China
10. Department of Chemotherapy, Guangxi Zhuang Autonomous Region Tumor Hospital, Nanning, People’s Republic of China
11. Department of Medical Oncology, the Affiliated Hospital of Medical College, Qingdao University, Qingdao, People’s Republic of China
12. Department of Oncology, Southwest Hospital, Third Military Medical University, Chongqing, People’s Republic of China
13. Department of Pulmonary Medicine, Zhongshan Hospital, Fudan University, 80 Feng Lin Rd, Shanghai, 200032, People’s Republic of China
14. Cancer Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, People’s Republic of China
15. Department of Medical Oncology, Jiangsu Cancer Hospital, No. 42 Baizi ting, Nanjing, 210009, Jiangsu Province, People’s Republic of China
16. Department of Thoracic Medical Oncology, Beijing Cancer Hospital, Beijing, People’s Republic of China
17. Department of Medical Oncology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, People’s Republic of China
18. Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA
Abstract:

Purpose

Aprepitant, an oral neurokinin-1 receptor antagonist, has demonstrated improved control of chemotherapy-induced nausea and vomiting (CINV) in previous studies. This is the first phase III study to evaluate the efficacy and tolerability of aprepitant in patients receiving highly emetogenic chemotherapy (HEC) in Asian countries.

Methods

This multicenter, double-blind, placebo-controlled trial assessed the prevention of CINV during the acute phase (AP), delayed phase (DP), and overall phase (OP). Patients receiving HEC were randomized to either an aprepitant group (day 1, aprepitant 125 mg; days 2–3, aprepitant 80 mg) or a standard therapy group (days 1–3, placebo). Both groups received intravenous granisetron and oral dexamethasone. The primary end point was complete response (CR; no emesis and no use of rescue therapy) during the OP.

Results

Of the 421 randomized patients, 411 (98 %) were assessable for efficacy; 69.6 % (142/204) and 57.0 % (118/207) of patients reported CR during the OP in the aprepitant and standard therapy groups, respectively (P?=?0.007). CR rates in the aprepitant group were higher during the DP (74.0 % vs. 59.4 %, P?=?0.001) but were similar during the AP (79.4 % vs. 79.3 %, P?=?0.942). Toxicity and adverse events were comparable in both groups.

Conclusions

The addition of aprepitant to standard antiemetic treatment regimens for Chinese patients undergoing HEC provided superior CINV prevention and was well tolerated.
Keywords:
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