Results of a 7-day aprepitant schedule for the prevention of nausea and vomiting in 5-day cisplatin-based germ cell tumor chemotherapy
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.
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.
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.
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.
KeywordsAprepitant Dexamethasone 5Hydroxytryptamine3 receptor antagonist 5-day cisplatin Antiemetic Germ cell tumors
The authors acknowledge the contributions of the patients and the investigators. This study was conducted under the auspices of ANZUP and coordinated by the National Health and Medical Research Council Clinical Trials Centre, University of Sydney. It was supported in part by drug supply from Investigator-Initiated Studies Program of Merck and Co. and research grant from Merck Sharp & Dohme (Australia) Pty Limited. IDD is supported by an NHMRC Practitioner Fellowship. The opinions expressed in this paper are those of the authors and do not necessarily represent those of Merck & Co or Merck Sharpe & Dohme (Australia) Pty Limited.
Conflict of interest
Two of the authors, Ian Olver and Martin Stockler, applied for and received a grant from Merck Sharp & Dohme (Australia) Pty Limited to partly fund this study but have no other relationship with this company to declare. None of the authors have other conflicts of interest to declare. The authors had full control of the primary data and agree to allow the journal to review those data if requested.
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