Phase II open label pilot trial of aprepitant and palonosetron for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic FOLFOX chemotherapy for the treatment of colorectal cancer

Abstract

Purpose

Chemotherapy-induced nausea and vomiting (CINV) causes significant morbidity among colorectal cancer patients, receiving fluorouracil, oxaliplatin, and leucovorin (FOLFOX) chemotherapy even with standard antiemetic prophylaxis. The purpose of this study is to determine if the addition of aprepitant to standard antiemetic therapy improves CINV in these patients.

Methods

Patients receiving FOLFOX for colorectal cancer were given antiemetic prophylaxis with aprepitant 125 mg orally on day 1 and 80 mg on days 2 and 3. Palonosetron 0.25 mg was given IV push on day 1 only. Dexamethasone 12 mg was administered orally on day 1 and 8 mg each morning on days 2 through 4. Assessments including emetic events, rescue doses, nutritional intake, and appetite were recorded in a patient diary which was returned to study personnel in the following cycle.

Results

Of the 53 patients screened, 50 were evaluable and had a complete dataset for cycle 1. For the first cycle, 74% of patients achieved a complete response (CR), 22% achieved a major response and 4% experienced treatment failure. The percentage of patients achieving a CR remained high throughout each cycle at 83, 83, and 86% for cycles 2, 3, and 4, respectively. Appetite and nutritional status remained largely unchanged throughout treatment. Adverse events occurring in more than 10% of patients included diarrhea (13.6%), fatigue (12.6%), and neutropenia (11%).

Conclusions

Aprepitant added to standard antiemetic therapy appears to be an effective and safe regimen for prevention of CINV in patients receiving FOLFOX.

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Funding

This study is funded by Merck & Co., Inc., Kenilworth, NJ.

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Authors

Corresponding author

Correspondence to Alison Palumbo.

Ethics declarations

Dr. Bubalo reports grants from Merck during the conduct of the study. All other authors have nothing to disclose.

Conflict of interest

The authors declare that they have no conflict of interest.

Disclosure

All other authors have nothing to disclose.

Additional information

Dr. Edwards was at Walter Reed Army Medical Center when the study was completed.

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Bubalo, J.S., Herrington, J.D., Takemoto, M. et al. Phase II open label pilot trial of aprepitant and palonosetron for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic FOLFOX chemotherapy for the treatment of colorectal cancer. Support Care Cancer 26, 1273–1279 (2018). https://doi.org/10.1007/s00520-017-3950-y

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Keywords

  • Aprepitant
  • FOLFOX
  • Chemotherapy
  • Nausea
  • Vomiting