Palonosetron compared with ondansetron in pediatric cancer patients: multicycle analysis of a randomized Phase III study

Aim: To investigate across multiple cycles the efficacy and safety of palonosetron in the prevention of chemotherapy-induced nausea and vomiting in pediatric cancer patients receiving highly or moderately emetogenic chemotherapy (HEC/MEC). Patients & methods: Patients were randomly assigned to 10, 20 mu g/kg palonosetron or 3 x 150 mu g/kg ondansetron for up to four cycles of HEC/MEC. Results: In all on-study chemotherapy cycles, complete response rates were higher in patients in the 20 mu g/kg palonosetron group than the ondansetron group. Treatment-emergent adverse events were comparable between the palonosetron 20 mu g/kg and ondansetron groups. Conclusion: Over four cycles of HEC/MEC, 20 mu g/kg palonosetron was an efficacious and safe treatment for the prevention of chemotherapy-induced nausea and vomiting in pediatric cancer patients