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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

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Author(s)
Do-Jin KimMyung-Ah LeeMyung-Ju AhnKil Yeon LeeSun Jin SymJeong Eun KimJoung-SoonJae-Weon KimYong Lee SungChi-Heum ChoMyong Choel LimHun JungEun Kim ChoKyung Wan Min
Keimyung Author(s)
Cho, Chi Heum
Department
Dept. of Obstetrics & Gynecology (산부인과학)
Journal Title
Supportive Care in Cancer
Issued Date
2017
Volume
25
Issue
3
Keyword
AprepitantNeurokinin-1 receptor antagonistsModerately emetogenic chemotherapyChemotherapy-induced nausea and vomiting
Abstract
Purpose; This study evaluated the efficacy and safety of a 3-
day aprepitant regimen for the prevention of chemotherapyinduced
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.
Keimyung Author(s)(Kor)
조치흠
Publisher
School of Medicine
Citation
Do-Jin Kim et al. (2017). 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. Supportive Care in Cancer, 25(3), 801–809. doi: 10.1007/s00520-016-3463-0
Type
Article
ISSN
0941-4355
Source
https://link.springer.com/article/10.1007%2Fs00520-016-3463-0
DOI
10.1007/s00520-016-3463-0
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/32852
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Obstetrics & Gynecology (산부인과학)
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