Olver, I.Grimison, P.Chatfield, M.Stockler, M.Toner, G.Gebski, V.Harrup, R.Underhill, C.Kichenadasse, G.Singhal, N.Davis, I.Boland, A.McDonald, A.Thomson, D.2015-08-092015-08-092013Supportive Care in Cancer, 2013; 21(6):1561-15680941-43551433-7339http://hdl.handle.net/2440/93411PURPOSE: The purpose of this study was to determine the efficacy of adding a 7-day aprepitant schedule to a 5HT3 receptor antagonist and dexamethasone for patients with germ cell tumors receiving first-line 5-day cisplatin-based chemotherapy. METHODS: In a single-arm, open-label, multi-center, phase 2 trial, chemo-naive patients received aprepitant 125 mg PO (per oral) on day 1 and 80 mg PO on days 2 to 7, a 5HT3 receptor antagonist on days 1 to 5, and dexamethasone 8 mg on days 1 to 8. The primary endpoint was no emesis (vomiting or dry retching) during days 1 to 7 of cycle 1. RESULTS: Fifty patients were recruited. For cycle 1, proportions reporting no emesis on day 1, no emesis on days 1 to 7, no nausea on day 1, and no nausea on days 1 to 7 were 96, 82, 71, and 27%, respectively. The efficacy was maintained in all cycles with over 80% of patients reporting no emesis on any given day of any given cycle. Emesis was more common on days 4 to 7 (68% episodes) than on days 1 to 3 (32% episodes). Over any 24-h period, 49% of patients with emesis reported no more than two episodes, and 62% of patients with nausea reported intensity as 3 or less on a scale from 0 to 10. There were no unexpected or serious adverse events reported. CONCLUSION: Adding 7 days of aprepitant to a 5HT3 receptor antagonist and dexamethasone effectively controlled acute and delayed emesis with 5-day cisplatin regimens. Days of nausea were more common than days of vomiting.en© Springer-Verlag Berlin Heidelberg 2012AprepitantDexamethasone5Hydroxytryptamine3 receptor antagonist5-day cisplatinAntiemeticGerm cell tumorsJournal article003001147410.1007/s00520-012-1696-00003185167000062-s2.0-84879161805108256Olver, I. [0000-0001-5478-1576]