Single versus two doses of palonosetron for prevention of chemotherapy-induced nausea and vomiting in children: a double-blind placebo controlled randomized study.

Abstract

This single-centre, double-blinded, placebo-controlled randomized study aimed to assess the efficacy of single versus two doses of palonosetron in the prevention of chemotherapy-induced nausea and vomiting (CINV). Children receiving multiple-day (scheduled for ≥3 days) moderately or highly emetogenic chemotherapy (MEC/HEC) were randomized to receive either a single (day 1) or two doses (days 1 and 4) of intravenous palonosetron, in addition to the standard antiemetic prophylaxis. The primary efficacy endpoint was the proportion of patients with complete response (CR) for CIV in acute phase. One-hundred children receiving 307 blocks of MEC/HEC were randomized to receive one (Group A; n = 51) or two doses (Group B; n = 49) of palonosetron. Proportion of children showing CR for CIV was significantly higher during acute phase in Group B (69.4% vs. 49.0%, p = 0.04). There was no difference in response during delayed phase in two groups. On univariate analysis, younger patient (<10 years), those with solid tumours, did not receive dexamethasone that had significantly higher odds for breakthrough vomiting in Group A. None of these factors retained significance in multivariate logistic regression analysis. Additional intravenous dose of palonosetron on day 4 is effective in controlling CIV during acute phase in children receiving multiple-day MEC/HEC.