Efficacy and safety of granisetron compared with high-dose metoclopramide plus dexamethasone in patients receiving high-dose cisplatin in a single-blind study. The Granisetron Study Group.

The efficacy and safety of granisetron, a novel anti-emetic, were compared with those of high-dose metoclopramide plus dexamethasone in 234 patients undergoing treatment with high-dose cisplatin (greater than or equal to 49 mg/m2). In this single-blind study, granisetron (40 micrograms/kg; n = 114) was administered as a 5 min infusion, with two additional 40 micrograms/kg doses allowed to control any subsequent nausea and vomiting. In 120 patients, dexamethasone 12 mg was administered intravenously over 30 min, followed by a loading dose of 3 mg/kg metoclopramide. Metoclopramide maintenance dose of 4 mg/kg was then administered over 8 h. The single 5 min infusion of granisetron was at least as effective an anti-emetic as the standard regimen. Approximately 70% of patients in each treatment group were free from vomiting and had no, or only mild nausea in the first 24 h. Granisetron administration was more convenient than the combination dosing schedule for the comparator which was up to 9 h. Only one adverse event, headache, occurred in more than five patients in the granisetron group. However, 13 extrapyramidal reactions (five of them serious) were reported in the metoclopramide plus dexamethasone group.