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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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An Erratum to this article was published on 14 February 2017

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)

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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.

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Authors and Affiliations

  1. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic ro 43 gil, Sonpa-gu, Seoul, South Korea

    Jeong Eun Kim

  2. Department of Internal Medicine, Chung-Ang University College of Medicine, 101 Heukseok-ro, Dongjak-gu, Seoul, South Korea

    Joung-Soon Jang

  3. Department of Obstetrics and Gynecology, Seoul National University College of Medicine, 101 Daehak-ro Jongno-gu, Seoul, South Korea

    Jae-Weon Kim

  4. Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, Korea University College of Medicine, 73 Inchon-ro, Seongbuk-gu, Seoul, South Korea

    Yong Lee Sung

  5. Department of Obstetrics and Gynecology, School of Medicine, Keimyung University, 56 Dalseungro Jungku, Daegu, South Korea

    Chi-Heum Cho

  6. Department of Medical Oncology, Seoul St. Mary’s Hospital, The Catholic University of Korea, 90 1 Hyehwa-dong, Jongno-gu, Seoul, South Korea

    Myung-Ah Lee

  7. Division of Allergy and Respiratory Medicine, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, 170 Jomaru-ro, Wonmi-gu, Bucheon, South Korea

    Do-Jin Kim

  8. Division of Hematology-Oncology, Department of Medicine, The Samsung Medical Center, Sungkyunkwan University School of Medicine, 135-710 Irwon-dong, Gangnam-gu, Seoul, South Korea

    Myung-Ju Ahn

  9. Department of Surgery, Kyung Hee University School of Medicine, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, South Korea

    Kil Yeon Lee

  10. Division of Hematology and Medical Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon Regional Cancer Center, Gachon University School of Medicine, 1198 Guwol-dong, Namdong-Gu, Incheon, South Korea

    Sun Jin Sym

  11. Gynecologic Cancer Branch, Research Institute and Hospital, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, South Korea

    Myong Choel Lim

  12. Merck Sharp & Dohme, 942-10 Daechi-dong, Gangnam-gu, Seoul, South Korea

    Hun Jung, Eun Kim Cho & Kyung Wan Min

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  1. Jeong Eun Kim
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Corresponding author

Correspondence to Joung-Soon Jang.

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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.

Additional information

An erratum to this article is available at http://dx.doi.org/10.1007/s00520-017-3608-9.

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Kim, J.E., Jang, JS., Kim, JW. et al. 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. Support Care Cancer 25, 801–809 (2017). https://doi.org/10.1007/s00520-016-3463-0

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  • DOI: https://doi.org/10.1007/s00520-016-3463-0

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