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Supportive Care in Cancer

, Volume 25, Issue 3, pp 801–809 | Cite as

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 JangEmail author
  • Jae-Weon Kim
  • Yong Lee Sung
  • 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
Original Article

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.

Keywords

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

Notes

Acknowledgements

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.

Author contributions

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.

Ethical approval

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.

Supplementary material

520_2016_3463_MOESM1_ESM.docx (27 kb)
ESM 1 (DOCX 27 kb)

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Copyright information

© Springer-Verlag Berlin Heidelberg 2016

Authors and Affiliations

  • Jeong Eun Kim
    • 1
  • Joung-Soon Jang
    • 2
    Email author
  • Jae-Weon Kim
    • 3
  • Yong Lee Sung
    • 4
  • Chi-Heum Cho
    • 5
  • Myung-Ah Lee
    • 6
  • Do-Jin Kim
    • 7
  • Myung-Ju Ahn
    • 8
  • Kil Yeon Lee
    • 9
  • Sun Jin Sym
    • 10
  • Myong Choel Lim
    • 11
  • Hun Jung
    • 12
  • Eun Kim Cho
    • 12
  • Kyung Wan Min
    • 12
  1. 1.Department of OncologyAsan Medical Center, University of Ulsan College of MedicineSeoulSouth Korea
  2. 2.Department of Internal MedicineChung-Ang University College of MedicineSeoulSouth Korea
  3. 3.Department of Obstetrics and GynecologySeoul National University College of MedicineSeoulSouth Korea
  4. 4.Division of Respiratory and Critical Care Medicine, Department of Internal MedicineKorea University College of MedicineSeoulSouth Korea
  5. 5.Department of Obstetrics and Gynecology, School of MedicineKeimyung UniversityDaeguSouth Korea
  6. 6.Department of Medical OncologySeoul St. Mary’s Hospital, The Catholic University of KoreaSeoulSouth Korea
  7. 7.Division of Allergy and Respiratory Medicine, Department of Internal MedicineSoonchunhyang University Bucheon Hospital, Soonchunhyang University College of MedicineBucheonSouth Korea
  8. 8.Division of Hematology-Oncology, Department of Medicine, The Samsung Medical CenterSungkyunkwan University School of MedicineSeoulSouth Korea
  9. 9.Department of SurgeryKyung Hee University School of MedicineSeoulSouth Korea
  10. 10.Division of Hematology and Medical Oncology, Department of Internal MedicineGachon University Gil Medical Center, Incheon Regional Cancer Center, Gachon University School of MedicineIncheonSouth Korea
  11. 11.Gynecologic Cancer Branch, Research Institute and HospitalNational Cancer CenterGyeonggi-doSouth Korea
  12. 12.Merck Sharp & DohmeSeoulSouth Korea

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