title: Ramosetron Versus Ondansetron in Combination With Aprepitant and Dexamethasone for the Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: A Multicenter, Randomized Phase III Trial, KCSG PC10-21.
abstract: BACKGROUND
  A combination of serotonin receptor (5-hydroxytryptamine receptor type 3) antagonists, NK-1 receptor antagonist, and steroid improves the complete response (CR) of chemotherapy-induced nausea and vomiting (CINV) in cancer patients. Ramosetron's efficacy in this triple combination regimen has not been investigated. This prospective, multicenter, single-blind, randomized, phase III study compares a combination of ramosetron, aprepitant, and dexamethasone (RAD) with a combination of ondansetron, aprepitant, and dexamethasone (OAD) to prove the noninferiority of RAD in controlling highly emetogenic CINV.
  
  
  METHODS
  Aprepitant and dexamethasone were orally administered for both arms. Ramosetron and ondansetron were intravenously given to the RAD and OAD groups. The primary endpoint was no vomiting and retching and no need for rescue medication during the acute period (day 1); the noninferiority margin was -15%.
  
  
  RESULTS
  A total of 299 modified intention-to-treat cancer patients who received RAD (144 patients) and OAD (155 patients) were eligible for the efficacy analysis. The CR rates of RAD versus OAD were 97.2% versus 93.6% during the acute period, 77.8% versus 73.6% during the delayed period (day 2-5), and 77.1% versus 71.6% during the overall period. Furthermore, RAD was noninferior to OAD in subgroups stratified by age, cancer type, chemotherapeutic agents, and schedule. Repeated measures analysis showed that in male patients, RAD was superior to OAD. Profiles of adverse events were similar in both groups.
  
  
  CONCLUSIONS
  RAD is as effective and tolerable as OAD for CINV prevention in patients receiving highly emetogenic chemotherapy. Ramosetron could be considered one of the best partners for aprepitant.
authors.affiliation: Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea.
authors.forename: Hyo Jung
authors.initials: HJ
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.
authors.forename: Sang Won
authors.initials: SW
authors.lastname: Shin
authors.affiliation: Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Korea.
authors.forename: Eun-Kee
authors.initials: EK
authors.lastname: Song
authors.affiliation: Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Korea.
authors.forename: Na-Ri
authors.initials: NR
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.
authors.forename: Jun Suk
authors.initials: JS
authors.lastname: Kim
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Jin Seok
authors.initials: JS
authors.lastname: Ahn
authors.affiliation: Department of Internal Medicine, School of Medicine Chungnam National University and Chungnam National University Hospital, Daejeon, Korea.
authors.forename: Hwan-Jung
authors.initials: HJ
authors.lastname: Yun
authors.affiliation: Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea.
authors.forename: Yo-Han
authors.initials: YH
authors.lastname: Cho
authors.affiliation: Department of Internal Medicine, Keimyung University Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Korea.
authors.forename: Keon Uk
authors.initials: KU
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University College of Medicine, Seoul, Korea.
authors.forename: Si-Young
authors.initials: SY
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
authors.forename: Joung Soon
authors.initials: JS
authors.lastname: Jang
authors.affiliation: Department of Oncology, University of Ulsan College of Medicine and Asan Medical Center, Seoul, Korea.
authors.forename: Sang-We
authors.initials: SW
authors.lastname: Kim
authors.affiliation: Department of Hematology-Oncology, Ajou University Hospital, Ajou University School of Medicine, Suwon, Korea.
authors.forename: Hyun Woo
authors.initials: HW
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Seoul, Korea.
authors.forename: Se Ryeon
authors.initials: SR
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Kosin University Gospel Hospital, Kosin University College of Medicine, Busan, Korea.
authors.forename: Yang Soo
authors.initials: YS
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Ewha Medical Research Center, School of Medicine, Ewha Womans University, Seoul, Korea.
authors.forename: Soon Nam
authors.initials: SN
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Uijeongbu St. Mary's Hospital, The Catholic University of Korea, Gyeonggi-do, Korea.
authors.forename: Yoon Ho
authors.initials: YH
authors.lastname: Ko
authors.affiliation: Departments of Preventive Medicine and Clinical Epidemiology and Biostatistics, Ulsan University College of Medicine, Asan Medical Center, Seoul, Korea.
authors.forename: Hwa Jung
authors.initials: HJ
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea oncologykang@naver.com.
authors.forename: Jin-Hyoung
authors.initials: JH
authors.lastname: Kang
mesh_terms: D000368:Aged; D000932:Antiemetics / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D000077608:Aprepitant; D001562:Benzimidazoles / Q000627:therapeutic use; D003907:Dexamethasone / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000627:therapeutic use; D009325:Nausea / Q000139:chemically induced / Q000188:drug therapy*; D009369:Neoplasms / Q000188:drug therapy*; D017294:Ondansetron / Q000627:therapeutic use; D011446:Prospective Studies; D016037:Single-Blind Method; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000188:drug therapy*
chemical_list: D000932:Antiemetics; D001562:Benzimidazoles; D009025:Morpholines; D000077608:Aprepitant; D017294:Ondansetron; D003907:Dexamethasone; C071315:ramosetron
keywords: Aprepitant; Chemotherapy; Nausea; Ondansetron; Ramosetron; Vomiting