A controlled, dose-comparison study of granisetron for nausea and vomiting induced by cancer chemotherapy in children

Abstract

We investigated the efficacy and safety of granisetron in 40 pediatric oncology patients who received identical chemotherapy regimens for three courses. During the first course, the emetogenicity of each chemotherapy regimen was evaluated without granisetron. Next patients received one of two doses of intravenous granisetron, i.e. 20 or 40 mcg/kg during the second and third course of chemotherapy in a cross-over fashion. Out of the 40 patients, two children had no emetic episode during the 24 hour period following commencement of the first course of chemotherapy. Whereas, 23 patients receiving 20 μ/kg granisetron, and 22 patients receiving 40 μ/kg, obtained complete response (no emetic episode during the 24 hour period following commencement of chemotherapy) in the second or third course. When patients received 20 or 40 μ/kg of granisetron, all measured efficacy parameters were superior in comparison to the period when they were receiving no granisetron. There was no significant difference in the antiemetic effect between the two doses of granisetron. However, a dose-related improvement in efficacy was observed with granisetron in a certain subset of patients; that is, 4 of the 10 patients receiving 20 μ/kg, who had responded poorly with respect to nausea and vomiting, showed a complete or major response when the dose was increased to 40 μ/kg. One child developed somnolence. No other adverse events were observed. Granisetron is an effective and safe antiemetic for children receiving intensive chemotherapy regimens containing cisplatin, cyclophosphamide or methotrexate. When comparing the two doses of 20 and 40 μ/kg, 40 μ/kg appeared more effective; although the difference was not statistically significant.