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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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.
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.
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.
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.
KeywordsAprepitant Neurokinin-1 receptor antagonists Moderately emetogenic chemotherapy, Chemotherapy-induced nausea and vomiting
We would like to thank DreamCIS, Inc., for providing clinical research services for this study. Medical writing and editorial assistance was provided by Maxwell Chang and Traci Stuve of ApotheCom, Yardley, PA, with funding provided by Merck & Co., Inc., Kenilworth, NJ.
Jeong Eun Kim, Joung-Soon Jang, and Kyung Wan Min are responsible for the work described in this paper. All authors were involved in at least one of the following: conception, design, acquisition, analysis, statistical analysis, interpretation of data and drafting the manuscript and/or revising the manuscript for important intellectual content. Jae-Weon Kim, Myong Choel Lim, Kil Yeon Lee, and Sun Jin Sym were also responsible for provision of study materials or patients. All authors provided final approval of the version to be published.
Compliance with ethical standards
Conflict of interest
Hun Jung, Cho Eun Kim, and Kyung Wan Min are employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., who may potentially own stock and/or hold stock options in the company. The remainder of the authors has nothing to disclose.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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