Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Supportive and palliative care

3976 - Exploration of the heterogeneity of moderately emetogenic chemotherapy on response to fosaprepitant in a randomized phase 3 trial


08 Oct 2016


Supportive and palliative care


Cindy Weinstein


Annals of Oncology (2016) 27 (6): 497-521. 10.1093/annonc/mdw390


C. Weinstein1, K. Jordan2, S. Green1, E. Camacho3, S. Khanani4, E. Beckford-Brathwaite1, W. Vallejos1, L.W. Liang1, S.J. Noga5, B.L. Rapoport6

Author affiliations

  • 1 Department Of Clinical Research, Merck & Co., Inc., 07033 - Kenilworth/US
  • 2 Department Of Hematology And Oncology, Martin Luther University Halle-Wittenberg, 06120 - Halle/DE
  • 3 Department Of Hematology And Medical Oncology, Comprehensive Cancer Center at the Desert Regional Medical Center, Palm Springs/US
  • 4 Department Of Hematology/oncology, Reliant Medical Group, Worcester/US
  • 5 Department Of Oncology, Weinberg Cancer Institute, Baltimore/US
  • 6 Department Of Medical Oncology, Medical Oncology Center of Rosebank, Johannesburg/ZA


Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 3976


A single-day triple-antiemetic fosaprepitant (FA) regimen demonstrated superiority to a standard 3-day regimen for preventing chemotherapy induced nausea and vomiting (CINV) in subjects receiving nonanthracycline and cyclophosphamide (AC)-based moderately emetogenic chemotherapy (MEC). However, the impact of MEC emetogenicity and duration of chemotherapy warrants exploration.


This was a phase 3, global, randomized, double-blind, parallel-group study in adults scheduled to receive an IV dose of ≥1 MEC agents on treatment day 1. Subjects were randomly assigned 1:1 to a control or FA regimen. The control regimen consisted of 8 mg oral ondansetron, 20 mg dexamethasone, and IV saline as placebo before the first dose of MEC on day 1, and 8 mg oral ondansetron 8 hours after the first dose, and every 12 hours on days 2 and 3. The FA regimen consisted of the same dose of oral ondansetron on day 1, along with 12 mg dexamethasone and a single dose of 150 mg IV FA before the first dose of MEC on day 1, with no additional prophylactic antiemetic beyond day 1. Primary endpoint was complete response (CR; no vomiting or rescue medication) in the delayed phase (0 to 120 hours following MEC).


Overall, 1000 subjects were included in the intent-to-treat treat population (FA: n = 502; Control: n = 498). The primary endpoint was met (P 


A single-day FA regimen is effective for preventing CINV in subjects receiving non-AC MEC with/without carboplatin and in both single- and multiple-day chemotherapy regimens.

Clinical trial identification

ClinicalTrials.gov: NCT01594749; release: August 26, 2015

Legal entity responsible for the study

This work was supported by Merck & Co., Inc., Kenilworth, NJ


This work was supported by Merck & Co., Inc., Kenilworth, NJ


C. Weinstein, S. Green: Employee and stockholder of Merck & Co., Inc. K. Jordan: Honoraria for consultancy from Merck Sharp & Dohme (MSD), Merck & Co., Inc, Helsinn, and Pro-Strakan. E. Beckford-Brathwaite, W. Vallejos: Employee and stockholder of Merck & Co., Inc L.W. Liang: Employee of Merck & Co., Inc. S.J. Noga: Honoraria from Millenium and consultant or in an advisory role for Amgen and Millenium (now Takeda Oncology). B.L. Rapoport: Consultant or in an advisory role for and received payment for travel, accommodations, or expenses from MSD and Tesaro and also received payments for participation on speaker's bureau for MSD and Roche. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings