Efficacy and safety of aprepitant for the prevention of chemotherapy-induced nausea and vomiting during the first cycle of moderately emetogenic chemotherapy in Korean patients with a broad range of tumor types

Jeong Eun Kim, Joung Soon Jang, Jae Weon Kim, Sung Yong Lee, Chi Heum Cho, Myung Ah Lee, Do Jin Kim, Myung Ju Ahn, Kil Yeon Lee, Sun Jin Sym, Myong Choel Lim, Hun Jung, Eun Kim Cho, Kyung Wan Min

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Purpose: This study evaluated the efficacy and safety of a 3-day aprepitant regimen for the prevention of chemotherapy-induced nausea and vomiting (CINV) during the first cycle of non-anthracycline plus cyclophosphamide (AC)-based moderately emetogenic chemotherapy (MEC) based on government guidelines in Korean patients. Methods: This multicenter, randomized, double-blind, phase IV trial (NCT01636947) enrolled adult South Korean patients with a broad range of tumor types who were scheduled to receive a single dose of ≥1 MEC agent. Patients were randomized to a 3-day regimen of aprepitant (aprepitant regimen) or placebo (control regimen) on top of ondansetron plus dexamethasone. The primary and key secondary efficacy endpoints were the proportions of subjects who achieved no vomiting and complete response (CR) during the overall phase. Results: Of the 494 randomized subjects, 480 were included in the modified intent-to-treat population. Response rates for no vomiting and CR in the overall phase were numerically higher for the aprepitant regimen compared with the control regimen groups, but failed to reach statistical significance (no vomiting 77.2 vs 72.0%; p = 0.191; CR 73.4 vs 70.4%; p = 0.458). Both the aprepitant and control regimens were generally well tolerated. Conclusion: A 3-day aprepitant regimen was numerically better but not statistically superior to a control regimen with respect to the achievement of no vomiting or CR during the overall phase in a non-AC MEC Korean population based on government reimbursement guidelines. Trial registration: ClinicalTrials.gov NCT01636947 (https://clinicaltrials.Gov/ct2/show/NCT01636947)

Original languageEnglish
Pages (from-to)801-809
Number of pages9
JournalSupportive Care in Cancer
Volume25
Issue number3
DOIs
Publication statusPublished - 2017 Mar 1

Fingerprint

aprepitant
Nausea
Vomiting
Safety
Drug Therapy
Neoplasms
Cyclophosphamide
Guidelines
Ondansetron
Dexamethasone
Population
Placebos

Keywords

  • Aprepitant
  • Chemotherapy-induced nausea and vomiting
  • Moderately emetogenic chemotherapy
  • Neurokinin-1 receptor antagonists

ASJC Scopus subject areas

  • Oncology

Cite this

Efficacy and safety of aprepitant for the prevention of chemotherapy-induced nausea and vomiting during the first cycle of moderately emetogenic chemotherapy in Korean patients with a broad range of tumor types. / Kim, Jeong Eun; Jang, Joung Soon; Kim, Jae Weon; Lee, Sung Yong; Cho, Chi Heum; Lee, Myung Ah; Kim, Do Jin; Ahn, Myung Ju; Lee, Kil Yeon; Sym, Sun Jin; Lim, Myong Choel; Jung, Hun; Cho, Eun Kim; Min, Kyung Wan.

In: Supportive Care in Cancer, Vol. 25, No. 3, 01.03.2017, p. 801-809.

Research output: Contribution to journalArticle

Kim, Jeong Eun ; Jang, Joung Soon ; Kim, Jae Weon ; Lee, Sung Yong ; Cho, Chi Heum ; Lee, Myung Ah ; Kim, Do Jin ; Ahn, Myung Ju ; Lee, Kil Yeon ; Sym, Sun Jin ; Lim, Myong Choel ; Jung, Hun ; Cho, Eun Kim ; Min, Kyung Wan. / Efficacy and safety of aprepitant for the prevention of chemotherapy-induced nausea and vomiting during the first cycle of moderately emetogenic chemotherapy in Korean patients with a broad range of tumor types. In: Supportive Care in Cancer. 2017 ; Vol. 25, No. 3. pp. 801-809.
@article{2217180a11104a9e8d64828bf98d97d5,
title = "Efficacy and safety of aprepitant for the prevention of chemotherapy-induced nausea and vomiting during the first cycle of moderately emetogenic chemotherapy in Korean patients with a broad range of tumor types",
abstract = "Purpose: This study evaluated the efficacy and safety of a 3-day aprepitant regimen for the prevention of chemotherapy-induced nausea and vomiting (CINV) during the first cycle of non-anthracycline plus cyclophosphamide (AC)-based moderately emetogenic chemotherapy (MEC) based on government guidelines in Korean patients. Methods: This multicenter, randomized, double-blind, phase IV trial (NCT01636947) enrolled adult South Korean patients with a broad range of tumor types who were scheduled to receive a single dose of ≥1 MEC agent. Patients were randomized to a 3-day regimen of aprepitant (aprepitant regimen) or placebo (control regimen) on top of ondansetron plus dexamethasone. The primary and key secondary efficacy endpoints were the proportions of subjects who achieved no vomiting and complete response (CR) during the overall phase. Results: Of the 494 randomized subjects, 480 were included in the modified intent-to-treat population. Response rates for no vomiting and CR in the overall phase were numerically higher for the aprepitant regimen compared with the control regimen groups, but failed to reach statistical significance (no vomiting 77.2 vs 72.0{\%}; p = 0.191; CR 73.4 vs 70.4{\%}; p = 0.458). Both the aprepitant and control regimens were generally well tolerated. Conclusion: A 3-day aprepitant regimen was numerically better but not statistically superior to a control regimen with respect to the achievement of no vomiting or CR during the overall phase in a non-AC MEC Korean population based on government reimbursement guidelines. Trial registration: ClinicalTrials.gov NCT01636947 (https://clinicaltrials.Gov/ct2/show/NCT01636947)",
keywords = "Aprepitant, Chemotherapy-induced nausea and vomiting, Moderately emetogenic chemotherapy, Neurokinin-1 receptor antagonists",
author = "Kim, {Jeong Eun} and Jang, {Joung Soon} and Kim, {Jae Weon} and Lee, {Sung Yong} and Cho, {Chi Heum} and Lee, {Myung Ah} and Kim, {Do Jin} and Ahn, {Myung Ju} and Lee, {Kil Yeon} and Sym, {Sun Jin} and Lim, {Myong Choel} and Hun Jung and Cho, {Eun Kim} and Min, {Kyung Wan}",
year = "2017",
month = "3",
day = "1",
doi = "10.1007/s00520-016-3463-0",
language = "English",
volume = "25",
pages = "801--809",
journal = "Supportive Care in Cancer",
issn = "0941-4355",
publisher = "Springer Verlag",
number = "3",

}

TY - JOUR

T1 - Efficacy and safety of aprepitant for the prevention of chemotherapy-induced nausea and vomiting during the first cycle of moderately emetogenic chemotherapy in Korean patients with a broad range of tumor types

AU - Kim, Jeong Eun

AU - Jang, Joung Soon

AU - Kim, Jae Weon

AU - Lee, Sung Yong

AU - Cho, Chi Heum

AU - Lee, Myung Ah

AU - Kim, Do Jin

AU - Ahn, Myung Ju

AU - Lee, Kil Yeon

AU - Sym, Sun Jin

AU - Lim, Myong Choel

AU - Jung, Hun

AU - Cho, Eun Kim

AU - Min, Kyung Wan

PY - 2017/3/1

Y1 - 2017/3/1

N2 - Purpose: This study evaluated the efficacy and safety of a 3-day aprepitant regimen for the prevention of chemotherapy-induced nausea and vomiting (CINV) during the first cycle of non-anthracycline plus cyclophosphamide (AC)-based moderately emetogenic chemotherapy (MEC) based on government guidelines in Korean patients. Methods: This multicenter, randomized, double-blind, phase IV trial (NCT01636947) enrolled adult South Korean patients with a broad range of tumor types who were scheduled to receive a single dose of ≥1 MEC agent. Patients were randomized to a 3-day regimen of aprepitant (aprepitant regimen) or placebo (control regimen) on top of ondansetron plus dexamethasone. The primary and key secondary efficacy endpoints were the proportions of subjects who achieved no vomiting and complete response (CR) during the overall phase. Results: Of the 494 randomized subjects, 480 were included in the modified intent-to-treat population. Response rates for no vomiting and CR in the overall phase were numerically higher for the aprepitant regimen compared with the control regimen groups, but failed to reach statistical significance (no vomiting 77.2 vs 72.0%; p = 0.191; CR 73.4 vs 70.4%; p = 0.458). Both the aprepitant and control regimens were generally well tolerated. Conclusion: A 3-day aprepitant regimen was numerically better but not statistically superior to a control regimen with respect to the achievement of no vomiting or CR during the overall phase in a non-AC MEC Korean population based on government reimbursement guidelines. Trial registration: ClinicalTrials.gov NCT01636947 (https://clinicaltrials.Gov/ct2/show/NCT01636947)

AB - Purpose: This study evaluated the efficacy and safety of a 3-day aprepitant regimen for the prevention of chemotherapy-induced nausea and vomiting (CINV) during the first cycle of non-anthracycline plus cyclophosphamide (AC)-based moderately emetogenic chemotherapy (MEC) based on government guidelines in Korean patients. Methods: This multicenter, randomized, double-blind, phase IV trial (NCT01636947) enrolled adult South Korean patients with a broad range of tumor types who were scheduled to receive a single dose of ≥1 MEC agent. Patients were randomized to a 3-day regimen of aprepitant (aprepitant regimen) or placebo (control regimen) on top of ondansetron plus dexamethasone. The primary and key secondary efficacy endpoints were the proportions of subjects who achieved no vomiting and complete response (CR) during the overall phase. Results: Of the 494 randomized subjects, 480 were included in the modified intent-to-treat population. Response rates for no vomiting and CR in the overall phase were numerically higher for the aprepitant regimen compared with the control regimen groups, but failed to reach statistical significance (no vomiting 77.2 vs 72.0%; p = 0.191; CR 73.4 vs 70.4%; p = 0.458). Both the aprepitant and control regimens were generally well tolerated. Conclusion: A 3-day aprepitant regimen was numerically better but not statistically superior to a control regimen with respect to the achievement of no vomiting or CR during the overall phase in a non-AC MEC Korean population based on government reimbursement guidelines. Trial registration: ClinicalTrials.gov NCT01636947 (https://clinicaltrials.Gov/ct2/show/NCT01636947)

KW - Aprepitant

KW - Chemotherapy-induced nausea and vomiting

KW - Moderately emetogenic chemotherapy

KW - Neurokinin-1 receptor antagonists

UR - http://www.scopus.com/inward/record.url?scp=84994389340&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84994389340&partnerID=8YFLogxK

U2 - 10.1007/s00520-016-3463-0

DO - 10.1007/s00520-016-3463-0

M3 - Article

C2 - 27826874

AN - SCOPUS:84994389340

VL - 25

SP - 801

EP - 809

JO - Supportive Care in Cancer

JF - Supportive Care in Cancer

SN - 0941-4355

IS - 3

ER -