Single-Dose Palonosetron Is Non-Inferior to Multiple Daily Doses of Ondansetron in Pediatric Patients

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According to findings presented at the International Society of Paediatric Oncology (SIOP) congress in Toronto, Ontario, Canada, palonosetron 20 mcg/kg is an effective option for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients up to age 17.

Researchers from the Helsinn Group conducted a phase 3, double-blind, double-dummy, randomized, parallel group study to investigate whether palonosetron is non-inferior to ondansetron for the prevention of CINV in pediatric patients undergoing treatment with chemotherapy. The researchers enrolled 502 patients and randomly stratified them to receive either palonosetron at a dose of 10 or 20 mcg/kg or ondansetron at at dose of 0.15 mg/kg six times a day up to 32 mg/day.

Results showed that palonosetron administered at a dose of 20 mcg/kg once was non-inferior to multiple daily doses of ondansetron 0.15 mg/kg in pediatric patients receiving highly emetogenic chemotherapy. In addition, the study found that palonosetron at a standard dose of 20 mcg/kg does not need to be dose adjusted depending on the patient's age.

The researchers did not observe any safety issues that would be of concern. The U.S. Food and Drug Administration has already approved intravenous palonosetron for the prevention of acute CINV in pediatric patients.

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Palonosetron an effective option in patients up to age 17.

Helsinn Group, presented data at the International Society of Paediatric Oncology (SIOP) congress establishing that palonosetron, at a dose 20 mug/kg, is a valuable and efficacious treatment option for chemotherapy-induced nausea and vomiting (CINV) in pediatric patients up to 17 years of age. CINV is a common and distressing side-effect of chemotherapy which, if inadequately controlled, can lead to dehydration, electrolyte imbalance and hospitalization.

The data (presented at the SIOP congress in Toronto, 22-24 October, today, October 23rd) derive from a large randomized trial and establish that the investigated higher dose palonosetron (20 mug/kg), given as a single dose, demonstrated similar efficacy to multiple daily administrations of ondansetron up to 32mg/day (considered current standard of care) in the prevention of CINV in pediatric patients receiving highly emetogenic chemotherapy.

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