Aprepitant versus metoclopramide, both combined with dexamethasone, for preventing cisplatin-induced delayed emesis: A randomized, double-blind study.

• DOI: 10.1200/jco.2014.32.15_suppl.9503
• Publication Date: 2019-01-03T17:38:23Z
• Authors: Fausto Roila; Enzo Ballatori; Benedetta Ruggeri; Sonia Fatigoni; Aurora Mirabile; Barbara Frau; Luigi Cavanna; Sergio Fava; Ida Colantonio; Lucia Angelelli; Libero Ciuffreda; Stefania Eufemia ...; Filippo Zerilli
• Keywords: Aprepitant; Metoclopramide; Palonosetron; Clinical endpoint

9503 Background: A combination of aprepitant, a 5-HT3 receptor antagonist, and dexamethasone is recommended for the prophylaxis cisplatin-induced nausea vomiting in acute phase, aprepitant+dexamethasone (A+D) delayed phase. Aim this study was to verify if A+D superior metoclopramide plus (M+D) preventing emesis cancer patients receiving same emesis. Methods: randomized double-blind comparing versus M+D completed previously untreated patients. Before chemotherapy, all were treated with intravenous palonosetron 0.25 mg, 8 oral aprepitant 125 mg. On day 2-4 randomly received mg qd 80 (days 2-3) or 20 qid bid. Primary endpoint rate complete response (no vomiting, no rescue treatment) 2-5 after chemotherapy. Results: Of 303 enrolled 288 evaluable, 147 A+D, 137 M+D. Day 1 results similar inboth arms. 2-5, not significantly different (80.3% 82.5% M+D, p<0.38, respectively), secondary endpoints also (complete protection, total control, nausea, score Functional Living Index-Emesis; p<0.24). Adverse events incidence between two treatments. Conclusions: In submitted cisplatin-based antiemetic foracute emesis, both treatments present toxicity. Clinical trial information: NCT00869310.