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, 03/10/2011
Clinical Article
Grunberg S et al. – Given with ondansetron and dexamethasone, single-dose intravenous fosaprepitant (150 mg) was noninferior to standard 3-day oral aprepitant in preventing CINV during OP and DP.
Methods- Randomized, double-blind, active-control design used to test whether fosaprepitant is noninferior to aprepitant
- Patients receiving cisplatin ≥ 70 mg/m2 for first time received ondansetron and dexamethasone with standard aprepitant regimen (125 mg on day 1, 80 mg on day 2, 80 mg on day 3) or single-dose fosaprepitant regimen (150 mg on day 1)
- Primary end point complete response (CR; no vomiting, no rescue medication) during OP
- Secondary end points CR during DP and no vomiting during OP
- Accrual of 1,113 evaluable patients per treatment arm planned to confirm noninferiority with expected CR of 67.7% and noninferiority margin of minus 7 percentage points
- Total of 2,322 patients randomly assigned, and 2,247 evaluable for efficacy
- Antiemetic protection with aprepitant and fosaprepitant equivalent within predefined bounds for noninferiority
- Both regimens well tolerated, although more frequent infusion site pain/erythema/thrombophlebitis seen with fosaprepitant relative to aprepitant (2.7% v 0.3%)
