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A Randomized Controlled Pilot Study Comparing the Impact of Aprepitant and Fosaprepitant on Chemotherapy Induced Nausea and Vomiting in Patients Treated for Gynecologic Cancer
  1. John P. Micha, MD*,
  2. Mark A. Rettenmaier, MD*,
  3. John V. Brown, MD*,
  4. Alberto Mendivil, MD*,
  5. Lisa N. Abaid, MD*,
  6. Katrina L. Lopez and
  7. Bram H. Goldstein, PhD
  1. *Gynecologic Oncology Associates; and
  2. Nancy Yeary Women’s Cancer Research Foundation, Newport Beach, CA.
  1. Address correspondence and reprint requests to Bram H. Goldstein, PhD, Gynecologic Oncology Associates, 351 Hospital Rd, Suite 507, Newport Beach, CA 92663. E-mail: bram@gynoncology.com.

Abstract

Objective The purpose of this pilot study was to compare the response rates and daily living activities of patients with newly diagnosed gynecologic cancer treated with fosaprepitant or aprepitant in the management of chemotherapy-induced nausea and vomiting.

Methods and Materials Eligible participants were randomized to either intravenous fosaprepitant (150 mg, day 1) or oral aprepitant (125 mg on day 1 and 80 mg on days 2–3) before undergoing weekly paclitaxel (80 mg/2)2 and monthly carboplatin (AUC 6)–based chemotherapy. In addition, standard premedications (eg, ranitidine, dexamethasone, and diphenhydramine) were administered intravenously on day 1. Response evaluation and impact on daily life were measured throughout the acute phase (0–24 hours), delayed period (days 2–4), and overall phase (0-120 hours) of the patients’ initial chemotherapy cycle via the Functional Living Index-Emesis.

Results In the current investigation, 20 gynecologic cancer subjects were treated with either fosaprepitant (n = 10) or aprepitant (n = 10) before their first chemotherapy cycle. We observed 7 overall complete responses (70%, no emetic episodes or rescue medications) in the aprepitant group and 6 (60%) in the fosaprepitant cohort (P = 0.660). In addition, both treatment groups reported similarly, favorable rates of daily living activities throughout the acute (P = 0.626) and delayed (P = 0.648) phases of cycle 1 chemotherapy.

Conclusions The findings from the current analysis suggest that intravenous fosaprepitant and oral aprepitant confer beneficial antiemetic prevention. Moreover, the 2 medications theoretically afford a favorable impact on daily living, thereby potentially facilitating the completion of a patient’s clinically prescribed chemotherapy regimen.

  • Fosaprepitant
  • Aprepitant
  • CINV
  • Activities of daily living
  • FLIE

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Footnotes

  • This study was supported by Merck and Company and the Nancy Yeary Women’s Cancer Research Foundation.

  • The authors declare no conflicts of interest.