Effect of aprepitant on antiemetic protection in patients receiving moderately emetogenic chemotherapy plus high-dose cisplatin: Analysis of combined data from 2 phase III randomized clinical trials

2004 
8137 Background: Addition of the NK1 antagonist aprepitant significantly enhanced the efficacy of a standard antiemetic regimen (5-HT3 antagonist + dexamethasone (D)) in patients receiving highly emetogenic chemotherapy (Poli-Bigelli 2003; Hesketh 2003). An initial sensitivity analysis suggested this benefit may extend to patients receiving additional moderately emetic chemotherapy (MEC); to further explore that observation, we analyzed data pooled from the above 2 large trials, for the subset of patients receiving MEC plus cisplatin. Methods: 1043 patients receiving their first cisplatin-based (≥70mg/m2) chemotherapy were randomly assigned to a control group (ondansetron (O) 32 mg iv and D 20 mg po on day 1; D 8 mg twice daily on days 2–4) or an aprepitant (A) group (A 125 mg po plus O 32 mg and D 12 mg on day 1; A 80 mg and D 8 mg once daily on days 2–3; and D 8 mg on day 4). Randomization was stratified for use of concomitant chemotherapy and gender. The endpoint was complete response (no emesis and no...
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