Weinstein, C., Jordan, K., Green, S.A., Camacho, E., Khanani, S., Beckford-Brathwaite, E., . . . Rapoport, B. L. (2016). Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy: Results of a randomized, double-blind phase III trial. Annals of Oncology, 27, 172–178. 

To assess the efficacy and safety of a single dose of fosaprepitant (150 mg IV) combined with a 5-HT₃ receptor antagonist and a corticosteroid versus a standard 5-HT₃ receptor antagonist and a corticosteroid for the prevention of chemotherapy-induced nausea and vomiting (CINV)

Patients received fosaprepitant versus placebo with ondansetron plus dexamethasone on day 1. Oral ondansetron and dexamethasone were used. Patients who received fosaprepitant on day 1 received placebo medication on days 2–3, while those in the control group received ondansetron every 12 hours. Rescue medications were allowed at the discretion of the provider.

• N = 1,000   
• MEAN AGE = 59.6 years
• MALES: 40.6% in experimental group, 41.2% in standard group; FEMALES: 59.4% (experimental group), 58.8% (standard group)
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Multiple malignancies
• OTHER KEY SAMPLE CHARACTERISTICS: Patients who were treatment naïve and receiving moderately emetogenic chemotherapy (MEC)

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: Conducted at 125 sites across 30 countries

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care, palliative care 

• Randomized, double-blind, placebo-controlled trial

• Nausea and the Functional Living Index-Emesis (FLIE)—the research does not discuss how this was administered.  
• Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
• Events of clinical interest (reactions, thrombophlebitis, infusion-site pain, erythema, and induration) were recorded.

Complete response (CR) in delayed phase met superiority for the experimental fosaprepitant group versus the control group (p < 0.001) and for the overall phase (p < 0.001). Both regimens had high CR in the acute phase with no significant differences (p = 0.184). Fosaprepitant was superior to the control group for no vomiting in the overall phase (p < 0.001) and delayed phase (p < 0.001), and the time to first vomiting (p < 0.001). Fosaprepitant group had significantly more “no significant nausea” patients than the control group (p = 0.026).

Fosaprepitant demonstrated superior CR overall to oral ondansetron and dexamethasone alone in MEC regimens. These results are similar to results seen in highly emetogenic chemotherapy. Treatment differences of 0.1% in delayed and overall phases are seen to be clinically meaningful for patients.

• Measurement/methods not well described
• How often instruments were completed is unknown.
• Industry supported trial (Merck & Co, Inc.)
• Several authors are either employed, stockholders, and/or paid consultants of Merck & Co.

Fosaprepitant may be safely used in patients receiving MEC. Further study is warranted.