Supportive Care in Cancer

, Volume 18, Issue 4, pp 423–431 | Cite as

Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: a randomized, double-blind study

  • Bernardo L. Rapoport
  • Karin Jordan
  • Judith A. Boice
  • Arlene Taylor
  • Carole Brown
  • James S. Hardwick
  • Alexandra Carides
  • Timothy Webb
  • Hans-Joachim Schmoll
Original Article

Abstract

Purpose

Aprepitant was shown previously to be effective for prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC) in breast cancer patients receiving an anthracycline and cyclophosphamide (AC)-based regimen. This study assessed aprepitant in patients receiving a broad range of MEC regimens with a variety of tumor types.

Methods

This phase III, randomized, gender-stratified, double-blind trial enrolled patients with confirmed malignancies, naïve to MEC or highly emetogenic chemotherapy, who were scheduled to receive a single dose of at least one MEC agent. Patients received an aprepitant triple-therapy regimen (aprepitant, ondansetron, and dexamethasone) or a control regimen (ondansetron and dexamethasone) administered orally. Primary and key secondary efficacy endpoints were proportions of patients with no vomiting and complete response (no vomiting and no rescue medication), respectively, during the 120 h post-chemotherapy.

Results

Of 848 randomized patients, 77% were female, and 52% received non-AC-based antineoplastic regimens. Significantly, more patients in the aprepitant group achieved no vomiting and complete response, regardless of whether they received AC or non-AC regimens, in the 120 h after chemotherapy. Overall, the incidences of adverse events were generally similar in the aprepitant (62.8%) and control groups (67.2%).

Conclusions

The aprepitant regimen provided superior efficacy in the treatment of CINV in a broad range of patients receiving MEC (non-AC or AC) in both no vomiting and complete response endpoints. Aprepitant was generally well tolerated. These results show the benefit of including aprepitant as part of the standard antiemetic regimen for cancer patients receiving MEC.

Keywords

Aprepitant NK1 antagonist Moderately emetogenic chemotherapy MEC Nausea and vomiting CINV 

Notes

Acknowledgements

This study was funded by Merck & Co., Inc., manufacturer of aprepitant. The authors wish to acknowledge Dr.’s Theodore Reiss and Stuart Green for contributions to the protocol design and Dr. Reiss for guidance throughout the course of the study.

Conflicts of interest

J.A.B., A.T., C.B., J.S.H., and A.C. are employees of Merck & Co., Inc. who may own stock and/or hold stock options in the Company. B.L.R., K. J., and H.J.S. have served as scientific advisors to Merck & Co., Inc.

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Copyright information

© Springer-Verlag 2009

Authors and Affiliations

  • Bernardo L. Rapoport
    • 1
  • Karin Jordan
    • 2
  • Judith A. Boice
    • 3
  • Arlene Taylor
    • 4
  • Carole Brown
    • 4
  • James S. Hardwick
    • 4
  • Alexandra Carides
    • 4
  • Timothy Webb
    • 5
  • Hans-Joachim Schmoll
    • 2
  1. 1.Medical Oncology Center of RosebankJohannesburgSouth Africa
  2. 2.Departments of Internal Medicine and Oncology/HematologyMartin-Luther-University of Halle-WittenbergHalle/SaaleGermany
  3. 3.Merck Research LaboratoriesRahwayUSA
  4. 4.Merck Research LaboratoriesUpper GwyneddUSA
  5. 5.Genesis Cancer CenterHot SpringsUSA

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