Efficacy and safety of fosaprepitant in the prevention of nausea and vomiting following highly emetogenic chemotherapy in Chinese people: A randomized, double-blind, phase III study
机构：[1]Nanjing Medical University, Nanjing, China[2]The Affiliated Bayi Hospital of Nanjing University of Chinese Medicine, Nanjing, China[3]The First Affiliated Hospital of Nanjing Medical University, Nanjing, China江苏省人民医院[4]Jilin Cancer Hospital, Changchun, China[5]Linyi Cancer Hospital, Linyi, China[6]The Second Affiliated Hospital of Anhui Medical University, Anhui, China[7]Henan Cancer Hospital, Zhengzhou, China河南省肿瘤医院[8]Tangdu Hospital, Xi’an, China[9]Anhui Provincial Hospital, Hefei, China[10]Shandong Cancer Hospital, Qingdao, China[11]Harbin Medical University Cancer Hospital, Harbin, China[12]The First Affiliated Hospital of Bengbu Medical College, Bengbu, China[13]The Third Affiliated Hospital of Third Military Medical University, Chongqing, China[14]Yunnan Provincial Cancer Hospital, Kunming, China[15]Shanghai Chest Hospital, Shanghai, China[16]The Second Affiliated Hospital of Nanjing Medical University, Nanjing, China[17]The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China[18]Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China[19]The Affiliated Hospital of Xuzhou Medical College, Xuzhou, China[20]Beijing Chest Hospital of the Capital Medical College, Beijing, China[21]Nantong Tumor Hospital, Nantong, China[22]Sichuan Province Cancer Hospital, Chengdu, China四川省肿瘤医院
The prevention of chemotherapy-induced nausea and vomiting was one of the most challenging supportive care issues in oncology, especially to highly emetogenic chemotherapy (HEC). A total of 645 patients were randomized into fosaprepitant group (fosaprepitant/placebo 150mg d1 in combination with granisetron and dexamethasone) or aprepitant group (aprepitant/placebo 125mg d1; 80mg d2-d3 plus granisetron and dexamethasone).The primary endpoint was the percentage of patients who had a complete response (CR) over the entire treatment course (0-120hr, overall phase [OP]). It was assessed by using a non-inferiority model, with a non-inferiority margin of 10%. The difference of the CR rate was compared between two groups with chi-square analysis. Six hundred and twenty-six patients were included in the per protocol analysis. The percentage of patients with a CR in the fosaprepitant group was not inferior to that in the aprepitant group (90.85% versus 94.17%, p=.1302) during OP. Whether the cisplatin-based chemotherapy or not, the CR rate of the fosaprepitant group was not inferior to that of the aprepitant group. Both regimens were well tolerated. The most common adverse event was constipation. Fosaprepitant provided effective and well-tolerated control of nausea and vomiting associated with HEC in Chinese patients.
基金：
This work was sponsored by Chia Tai Tianqing
Pharmaceutical Group Co., Ltd.
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2017]版：
大类|4 区医学
小类|2 区护理3 区卫生保健与服务3 区康复医学4 区肿瘤学
最新[2023]版：
大类|4 区医学
小类|3 区护理4 区卫生保健与服务4 区肿瘤学4 区康复医学
JCR分区：
出版当年[2017]版：
Q1REHABILITATIONQ1NURSINGQ2HEALTH CARE SCIENCES & SERVICESQ3ONCOLOGY
最新[2023]版：
Q2NURSINGQ2REHABILITATIONQ3HEALTH CARE SCIENCES & SERVICESQ3ONCOLOGY
第一作者机构：[1]Nanjing Medical University, Nanjing, China[2]The Affiliated Bayi Hospital of Nanjing University of Chinese Medicine, Nanjing, China
共同第一作者：
通讯作者：
通讯机构：[2]The Affiliated Bayi Hospital of Nanjing University of Chinese Medicine, Nanjing, China[*1]The Affiliated Bayi Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
推荐引用方式(GB/T 7714)：
L.Q. Yang,X.C. Sun,Shukui Qin,et al.Efficacy and safety of fosaprepitant in the prevention of nausea and vomiting following highly emetogenic chemotherapy in Chinese people: A randomized, double-blind, phase III study[J].EUROPEAN JOURNAL OF CANCER CARE.2017,26(6):doi:10.1111/ecc.12668.
APA：
L.Q. Yang,X.C. Sun,Shukui Qin,Y. Cheng,J.H. Shi...&Y.X. Chen.(2017).Efficacy and safety of fosaprepitant in the prevention of nausea and vomiting following highly emetogenic chemotherapy in Chinese people: A randomized, double-blind, phase III study.EUROPEAN JOURNAL OF CANCER CARE,26,(6)
MLA：
L.Q. Yang,et al."Efficacy and safety of fosaprepitant in the prevention of nausea and vomiting following highly emetogenic chemotherapy in Chinese people: A randomized, double-blind, phase III study".EUROPEAN JOURNAL OF CANCER CARE 26..6(2017)
