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

Hyo Jung Kim, Sang Won Shin, Eun Kee Song, Na Ri Lee, Jun Suk Kim, Jin Seok Ahn, Hwan Jung Yun, Yo Han Cho, Keon Uk Park, Si Young Kim, Joung Soon Jang, Sang We Kim, Hyun Woo Lee, Se Ryeon Lee, Yang Soo Kim, Soon Nam Lee, Yoon Ho Ko, Hwa Jung Kim, Jin Hyoung Kang

Research output: Contribution to journalArticle

4 Citations (Scopus)

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,phaseIII studycomparesacombination 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 intravenouslygiventotheRADandOADgroups. Theprimaryendpoint was no vomiting and retching and no need for rescue medication duringtheacuteperiod(day1);thenoninferioritymarginwas215%. 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 ofRADversusOADwere97.2% 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. Conclusion.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.

Original languageEnglish
Pages (from-to)1440-1447
Number of pages8
JournalOncologist
Volume20
Issue number12
DOIs
Publication statusPublished - 2015 Oct 28

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aprepitant
Ondansetron
Nausea
Dexamethasone
Vomiting
Drug Therapy
ramosetron

Keywords

  • Aprepitant
  • Chemotherapy
  • Nausea
  • Ondansetron
  • Ramosetron
  • Vomiting

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

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. / Kim, Hyo Jung; Shin, Sang Won; Song, Eun Kee; Lee, Na Ri; Kim, Jun Suk; Ahn, Jin Seok; Yun, Hwan Jung; Cho, Yo Han; Park, Keon Uk; Kim, Si Young; Jang, Joung Soon; Kim, Sang We; Lee, Hyun Woo; Lee, Se Ryeon; Kim, Yang Soo; Lee, Soon Nam; Ko, Yoon Ho; Kim, Hwa Jung; Kang, Jin Hyoung.

In: Oncologist, Vol. 20, No. 12, 28.10.2015, p. 1440-1447.

Research output: Contribution to journalArticle

Kim, HJ, Shin, SW, Song, EK, Lee, NR, Kim, JS, Ahn, JS, Yun, HJ, Cho, YH, Park, KU, Kim, SY, Jang, JS, Kim, SW, Lee, HW, Lee, SR, Kim, YS, Lee, SN, Ko, YH, Kim, HJ & Kang, JH 2015, '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', Oncologist, vol. 20, no. 12, pp. 1440-1447. https://doi.org/10.1634/theoncologist.2015-0128
Kim, Hyo Jung ; Shin, Sang Won ; Song, Eun Kee ; Lee, Na Ri ; Kim, Jun Suk ; Ahn, Jin Seok ; Yun, Hwan Jung ; Cho, Yo Han ; Park, Keon Uk ; Kim, Si Young ; Jang, Joung Soon ; Kim, Sang We ; Lee, Hyun Woo ; Lee, Se Ryeon ; Kim, Yang Soo ; Lee, Soon Nam ; Ko, Yoon Ho ; Kim, Hwa Jung ; Kang, Jin Hyoung. / 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. In: Oncologist. 2015 ; Vol. 20, No. 12. pp. 1440-1447.
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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,phaseIII studycomparesacombination 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 intravenouslygiventotheRADandOADgroups. Theprimaryendpoint was no vomiting and retching and no need for rescue medication duringtheacuteperiod(day1);thenoninferioritymarginwas215{\%}. 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 ofRADversusOADwere97.2{\%} 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. Conclusion.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.",
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T1 - Ramosetron versus ondansetron in combination with aprepitant and dexamethasone for the prevention of highly emetogenic chemotherapy-induced nausea and vomiting

T2 - A multicenter, randomized phase III Trial, KCSG PC10-21

AU - Kim, Hyo Jung

AU - Shin, Sang Won

AU - Song, Eun Kee

AU - Lee, Na Ri

AU - Kim, Jun Suk

AU - Ahn, Jin Seok

AU - Yun, Hwan Jung

AU - Cho, Yo Han

AU - Park, Keon Uk

AU - Kim, Si Young

AU - Jang, Joung Soon

AU - Kim, Sang We

AU - Lee, Hyun Woo

AU - Lee, Se Ryeon

AU - Kim, Yang Soo

AU - Lee, Soon Nam

AU - Ko, Yoon Ho

AU - Kim, Hwa Jung

AU - Kang, Jin Hyoung

PY - 2015/10/28

Y1 - 2015/10/28

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KW - Chemotherapy

KW - Nausea

KW - Ondansetron

KW - Ramosetron

KW - Vomiting

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