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

5 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

Keywords

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

ASJC Scopus subject areas

  • Oncology

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