Grunberg, S., Chua, D., Maru, A., Dinis, J., DeVandry, S., Boice, J.A., … Herrstedt, J. (2011). Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with cisplatin therapy: Randomized, double-blind study protocol—EASE. Journal of Clinical Oncology, 29, 1495–1501. 

To evaluate the effectiveness of a single dose of fosaprepitant in combination with dexamethasone and 5-HT₃ for chemotherapy-induced nausea and vomiting (CINV)

• Patients who were to receive cisplatin were randomly assigned to the experimental group or the control group. The experimental group received a single, 150-mg dose of IV fosaprepitant administered with a 5-HT₃ receptor antagonist and a corticosteroid prior to cisplatin-based chemotherapy. The control group received matched placebos for the experimental regimen and the currently recommended three-day oral regimen of aprepitant for five days after treatment.
• Ondansetron and dexamethasone were administered at current dosing recommendations.
• Patients kept diaries of episodes of vomiting, daily nausea assessment, and use of rescue mediation.
• Adverse effects were assessed at each clinic visit.

• The study consisted of 2,322 participants.
• The median age was 56 years in the experimental group and 57 years old in the control group.
• The study group was 36.7% female and 63.3% male.
• The most frequent diagnosis was lung cancer. Other cancers were GI, reproductive or genitourinary, renal and urinary tract, and breast cancer.
• The study group was 56% white and 29% Asian.
• All patients were scheduled to receive their first course of cisplatin ≥ 70 mg/m².

The study was conducted at multiple outpatient settings in 27 different countries.

All patients were in active treatment.

The study was a double-blind, randomized-controlled, parallel group.

The following measurement tools were used.

• Visual analogue scale (VAS) 100 mm for assessment of nausea
• Daily diary to record vomiting or retching episodes
• Use of rescue therapy (Common Terminology for Adverse Events [CTAE v3.0])

• No significant differences were found between groups for the primary endpoint of no vomiting or retching episodes with no use of rescue medication or episodes during the delayed phase.
• No significant differences were found between groups for the proportion of subjects who reported no significant nausea (defined as < 25 on the VAS).
• Overall, in both groups, slightly more than 74% reported no episodes of vomiting or use of rescue therapy in the delayed phase for nausea.
• Overall, the adverse events seen with the fosaprepitant regimen was similar to that seen with the three-day aprepitant regimen.

• The fosaprepitant regimen as used was as effective for the prevention of acute and delayed nausea associated with cisplatin-based chemotherapy as the currently recommended oral aprepitant regimen.
• A single dose of 150 mg of fosaprepitant was sufficient to suppress delayed CINV for 2–5 days after therapy.

• Findings demonstrated that a single, IV-dose regimen with this agent is an effective alternative to oral neurokinin 1 (NK1) receptor antagonists used as currently recommended for prevention of delayed onset CINV.
• Nurses should be aware of potential infusion-site reactions.
• About one-fourth of patients were refractory to this regimen, indicating the continued need to explore individualized alternatives for maximum symptom control.
• The most effective timing of these treatments for prevention of delayed onset CINV is not yet fully clear.