1814MO - Addition of aprepitant improves acute emesis control in children and adolescents receiving induction chemotherapy for acute myeloid leukaemia: A randomized, open-label trial

Background

The use of aprepitant as an add-on prophylactic agent has been shown to improve chemotherapy-induced vomiting (CIV) in children receiving highly emetogenic chemotherapy. Anti-emetic prophylaxis is additionally challenging during induction chemotherapy for acute myeloid leukemia (AML), where the role of aprepitant has not been formally evaluated.

Methods

A randomized, open-label trial was conducted at our centre where chemotherapy naïve children between 5-18 years with diagnosis of AML being planned for induction chemotherapy (3+7 regimen) were included. All study participants received ondansetron (0.15mg/kg) 8 hourly for 8 days starting 30min prior to chemotherapy. Children belonging to aprepitant group additionally received aprepitant capsules (15-40 kg = days 1-3, 80 mg; >40 kg = day 1, 125 mg and days 2-3, 80 mg) starting from 1 h before chemotherapy. The proportion of patients with CIV in acute phase (day 1-day 8), delayed phase (day 9-day 13) and reported adverse effects were recorded. Acute and delayed nausea was also recorded as secondary end point.

Results

Total of 78 children were randomized (37 in the aprepitant group and 41 in the control group). The proportion of participants achieving a complete response in CIV was significantly higher in the aprepitant group compared to the control group overall (51% vs 22%; p=0.007) and especially in the acute phase (59% vs 29%; p=0.007). The time to the first episode of vomiting was also significantly higher in the aprepitant group (p=0.0004). The reported adverse events were similar between the two groups. There was no difference in acute and delayed nausea.

Conclusions

The use of aprepitant as add-on prophylactic anti-emetic during induction chemotherapy for AML significantly improves CIV rate in children especially in acute phase.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Dr Atul Sharma.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.