title: 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.
abstract: 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 150 mg d1 in combination with granisetron and dexamethasone) or aprepitant group (aprepitant/placebo 125 mg d1; 80 mg 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 (0-120 hr, 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.
authors.affiliation: Nanjing Medical University, Nanjing, China.|The Affiliated Bayi Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
authors.forename: L Q
authors.initials: LQ
authors.lastname: Yang
authors.affiliation: Nanjing Medical University, Nanjing, China.|The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
authors.forename: X C
authors.initials: XC
authors.lastname: Sun
authors.affiliation: The Affiliated Bayi Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
authors.forename: S K
authors.identifier: http://orcid.org/0000-0001-8928-6786
authors.initials: SK
authors.lastname: Qin
authors.affiliation: Jilin Cancer Hospital, Changchun, China.
authors.forename: Y
authors.initials: Y
authors.lastname: Cheng
authors.affiliation: Linyi Cancer Hospital, Linyi, China.
authors.forename: J H
authors.initials: JH
authors.lastname: Shi
authors.affiliation: The Second Affiliated Hospital of Anhui Medical University, Anhui, China.
authors.forename: Z D
authors.initials: ZD
authors.lastname: Chen
authors.affiliation: Henan Cancer Hospital, Zhengzhou, China.
authors.forename: Q M
authors.initials: QM
authors.lastname: Wang
authors.affiliation: Tangdu Hospital, Xi'an, China.
authors.forename: H L
authors.initials: HL
authors.lastname: Zhang
authors.affiliation: Anhui Provincial Hospital, Hefei, China.
authors.forename: B
authors.initials: B
authors.lastname: Hu
authors.affiliation: Shandong Cancer Hospital, Qingdao, China.
authors.forename: B
authors.initials: B
authors.lastname: Liu
authors.affiliation: Harbin Medical University Cancer Hospital, Harbin, China.
authors.forename: Q Y
authors.initials: QY
authors.lastname: Zhang
authors.affiliation: The First Affiliated Hospital of Bengbu Medical College, Bengbu, China.
authors.forename: Q
authors.initials: Q
authors.lastname: Wu
authors.affiliation: The Third Affiliated Hospital of Third Military Medical University, Chongqing, China.
authors.forename: D
authors.initials: D
authors.lastname: Wang
authors.affiliation: The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
authors.forename: Y Q
authors.initials: YQ
authors.lastname: Shu
authors.affiliation: Yunnan Provincial Cancer Hospital, Kunming, China.
authors.forename: J
authors.initials: J
authors.lastname: Dong
authors.affiliation: Shanghai Chest Hospital, Shanghai, China.
authors.forename: B H
authors.initials: BH
authors.lastname: Han
authors.affiliation: The Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.
authors.forename: K M
authors.initials: KM
authors.lastname: Wang
authors.affiliation: The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
authors.forename: C X
authors.initials: CX
authors.lastname: Dang
authors.affiliation: Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: J L
authors.initials: JL
authors.lastname: Li
authors.affiliation: The Affiliated Hospital of Xuzhou Medical College, Xuzhou, China.
authors.forename: H B
authors.initials: HB
authors.lastname: Wang
authors.affiliation: Beijing Chest Hospital of the Capital Medical College, Beijing, China.
authors.forename: B L
authors.initials: BL
authors.lastname: Li
authors.affiliation: Nantong Tumor Hospital, Nantong, China.
authors.forename: J G
authors.initials: JG
authors.lastname: Lu
authors.affiliation: Sichuan Province Cancer Hospital, Chengdu, China.
authors.forename: Z H
authors.initials: ZH
authors.lastname: Zhang
authors.affiliation: The Affiliated Bayi Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
authors.forename: Y X
authors.initials: YX
authors.lastname: Chen
mesh_terms: D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D000077608:Aprepitant; D044466:Asian People; D002681:China; D002945:Cisplatin / Q000009:adverse effects; D003907:Dexamethasone / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D017829:Granisetron / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000627:therapeutic use*; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D000932:Antiemetics; D000970:Antineoplastic Agents; D000077608:Aprepitant; D002945:Cisplatin; D003907:Dexamethasone; D017829:Granisetron; D009025:Morpholines; C579707:fosaprepitant
keywords: aprepitant; chemotherapy-induced nausea and vomiting; fosaprepitant