The efficacy of aprepitant for the patients receiving FOLFOXIRI and FOLFIRINOX: A phase II study.

560Background: Aprepitant (APR) showed the efficacy for the prevention of chemotherapy-induced nausea and vomiting (CINV) with highly emetogenic chemotherapy. The combination chemotherapies of moderately emetoegnic agents of oxaliplatin and irinotecan are classified as moderately emetogenic risk according to ASCO guideline, but showed severe vomiting and nausea. Methods: This phase II trial evaluated the efficacy of APR (day1;125mg, day2-3; 80mg) in patients receiving mFOLFOXIRI(oxaliplatin; 85 mg/m2, irinotecan; 150 mg/m2, leucovorin; 200 mg/m2, 5-FU infusional; 2400 mg/m2/46hour, every 2 weeks) and FOLFIRINOX (oxaliplatin; 85 mg/m2, irinotecan; 180 mg/m2, leucovorin;200 mg/m2, 5-FU bolus; 400 mg/m2, 5-FU infusional; 2400 mg/m2/46hour, every 2weeks). The primary objective was the complete vomiting inhibitation rate (CVIR) during first cycle. The null hypothesis and expectation of CVIR were 30% and 60% (one-sided α = 0.05, β = 1.0), so 23 patients were needed. CVIR was assessed according to MAT (MASCC Ant...