Efficacy of mirtazapine in preventing delayed nausea and vomiting induced by highly emetogenic chemotherapy: An open-label, randomized, multicenter phase III trial.

1078Background: We examined the efficacy of mirtazapine for the prevention of delayed nausea and vomiting in patients who received highly emetogenic chemotherapy (HEC). Methods: Patients with breast cancer who experienced delayed emesis after receiving AC or cisplatin containing regimens, and would subsequently accept at least 3 cycles of the same chemotherapy were randomly assigned to a mirtazapine group (15 mg daily on days 2 to 4) or control group, both with aprepitant, a 5-HT3 receptor antagonist and dexamethasone (7.5 mg on day 2 to 4). Primary end point was complete response (CR) to vomiting (no emesis and no rescue treatments) in the delayed phase (25 to 120 h). Secondary end points included CR during acute (0 to 24 h) and overall (0 to 120 h) periods, complete control (CC) (no emesis, no rescue medication use, and no more than grade 1 nausea) during the 3 periods above. Results: The study was closed early in January, 2018 due to the slow enrollment. Of 95 patients, 46 in the mirtazapine group and ...