Palonosetron 20 μg/kg during the acute phase of chemotherapy-induced nausea and vomiting (CINV) in pediatric patients undergoing moderately or highly emetogenic chemotherapy was noninferior to ondansetron 150 μg/kg for the prevention of CINV in these patients, a study published online ahead of print in the journal The Lancet Oncology has shown.1
Because palonosetron, a 5-HT3 receptor antagonist, is efficacious for the prevention of CINV in adults undergoing moderately or highly emetogenic chemotherapy, researchers sought to compare the efficacy and safety of palonosetron with ondansetron in pediatric patients.
For the international, double-blind, phase 3 trial, researchers enrolled 502 pediatric patients who were naïve or non-naïve to chemotherapy and were scheduled to undergo moderately or highly emetogenic cancer chemotherapy. Participants were randomly assigned 1:1:1 to receive up to 4 cycles of 10 μg/kg or 20 μg/kg palonosetron on day 1, or 3 doses of 150 μg/kg ondansetron on day 1 every 4 hours.
Results showed that in the acute phase, complete responses were observed in 54% of patients in the 10 μg/kg palonosetron group, 59% of patients in the 20 μg/kg palonosetron group, and 59% of patients in the ondansetron group. Researchers determined that palonosetron 20 μg/kg, but not 10 μg/kg, was noninferior to ondansetron in the acute phase (P=.0022).
In regard to safety, the most common treatment-related adverse events was nervous system disorders, particularly headache, which occurred in 2% of the 10 μg/kg palonosetron group, less than 1% of the 20 μg/kg palonosetron group, and 1% of the ondansetron group. Serious adverse events occurred in 31%, 26%, and 34% of patients, respectively.
Palonosetron 20 μg/kg is already approved by the US Food and Drug Administration for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy in pediatric patients age 1 month to younger than 17 years.
Kovács G, Wachtel A, Basharova E, et al. Palonosetron versus ondansetron for prevention of chemotherapy-induced nausea and vomiting in paediatric patients with cancer receiving moderately or highly emetogenic chemotherapy: a randomised, phase 3, double-blind, double-dummy, non-inferiority study [published online ahead of print January 18, 2016]. Lancet Oncology. doi:10.1016/S1470-2045(15)00520-3.