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Does a single dose of Palonosetron have any role in preventing chemotherapy-induced nausea and vomiting in pediatric patients? A double-blind, randomized controlled trial.

Objectives: Chemotherapy-induced nausea vomiting (CINV) is a troublesome
side-effect of chemotherapy in pediatric patients undergoing
Osteosarcoma treatment. The role of 5HT3 antagonists needs to be
explored for the same. The study aims to evaluate the superiority of
single-dose Palonosetron over Granisetron in pediatric patients
undergoing moderate emetogenic therapy for osteosarcoma. Materials and
Methods: In this double-blind, case-controlled, randomized study,
pediatric patients were assessed for acute nausea and vomiting following
moderate emetogenic chemotherapy for osteosarcoma. These children were
assigned to group I (palonosetron) and group II (Granisetron) without
other antiemetic prophylaxis. The primary objective variable was
children’s segment with complete response during the acute phase of the
first on-study chemotherapy cycle. Risk factors associated with the
trial were analyzed. The patients were followed for the first 24 hours
following chemotherapy. Results: A total number of 200 children were
evaluated, and other factors which might alter the response were
assessed into two groups. These 200 children underwent 604 blocks of
chemotherapy. The complete responses (CR) were documented in 83% and
72% receiving palonosetron and Granisetron, respectively, during the
acute phase. The only dexamethasone, used as rescue medication, was
found to be a significant risk factor that predisposed the response
(p<0.05) Conclusion: Palonosetron is an effective alternative
to Granisetron as a single dose for preventing CINV in children
receiving MEC for osteosarcoma.