Oral granisetron solution as prophylaxis for chemotherapy-induced emesis in children: double-blind study of two doses

This multicentric double-blind, dose-ranging study was to compare efficacy and safety of two oral doses of granisetron solution in the prevention of c hemotherapy-induced emesis in children with malignant diseases : 294 childr en, aged 1 to 16, treated with a moderately or highly emetogenic chemothera py were randomly assigned to receive oral granisetron either 20 mu g/kg (n = 143) or 40 mu g/kg (n = 151) before and 6 to 12 hours after the start of chemotherapy. Fifty-one percent of patients treated with 20 mu g/kg bd of o ral granisetron solution achieved a complete response (no vomiting, no wors e than mild nausea, no rescue therapy and no withdrawal during the specifie d period) and 59% achieved a major response (no more than one episode of vo miting, no worse than mild nausea, no rescue therapy and no withdrawal duri ng the specified period). There was no difference between the two oral dose s of granisetron. Treatment was rated as good or very good by investigators in 70% of cases. In conclusion, oral granisetron suspension either at 20 m u g/kg bd or at 40 mu g/kg bd showed good efficacy and safety in the preven tion of chemotherapy-induced emesis in children with malignant diseases. Or al granisetron solution can be used as prophylaxis of emesis in children re ceiving moderately or highly emetogenic chemotherapy.