A randomized trial of two doses of granisetron in the treatment of chemotherapy-induced emesis. Dutch results within a multinational study

Granisetron is a new serotonin-receptor antagonist with considerable activity in preclinical models and early clinical studies against drug-induced nausea and vomiting. In a randomized, double-blind trial, two dose levels of granisetron were compared with regard to their efficacy and safety if given to patients receiving emetogenic chemotherapy with or without cisplatin. The present paper reports the Dutch experience with 125 patients included in this international trial. The two dose levels (40 and 160 μg/kg given once i.v. prior to chemotherapy) were equally effective in preventing acute emesis and nausea (within the first 24 h); in the group receiving cisplatin doses of 50 mg/m² or more, 39% of patients had a complete response (no vomiting and mild nausea at most), with a complete response rate of 82% in the patients receiving moderately emetogenic chemotherapy. Sixty-three percent of patients receiving highly emetogenic chemotherapy with a complete response within 24 h lost this response during the next 6 days, as did 20% of the other patients. Headache was the most frequently reported adverse event (18%), followed by constipation (6%) and dizziness (4%). All adverse events were mild and occurred equally frequently at both dose levels. Granisetron at 40 μg/kg i.v. given once is effective in the prevention of acute chemotherapy-induced emesis and nausea, in particular in patients receiving moderately emetogenic therapy.