The efficacy and safety of granisetron in pediatric cancer patients who had failed standard antiemetic therapy during anticancer chemotherapy.

Purpose: This study was undertaken to evaluate the safety and efficacy of granisetron (a 5-hydroxytryptamine. antagonist) in children with malignant disease who had previously experienced unacceptable nausea and vomiting and/or adverse effects associated with standard antiemetic therapy.

Patients and methods: Thirty children 3-18 years of age who were receiving anticancer chemotherapy were enrolled in the study. Patients received a prophylactic dose of granisetron before chemotherapy and two subsequent doses as needed. If further antiemetics were required, standard therapy was given and those patients were classified as treatment failures. Patients received granisetron during one to three cycles of chemotherapy; a total of 66 courses were given.

Results: Eighty-seven percent of patients had good control of nausea and vomiting with granisetron alone; 90% of patients elected to receive granisetron with subsequent chemotherapy. No loss of efficacy was noted with repeated cycles in 21 patients. No serious adverse events occurred.

Conclusions: Intravenous granisetron (20 micrograms/kg/dose) appears to be a safe and effective drug for pediatric patients receiving emetogenic chemotherapy.