A comparison of two dose levels of granisetron in patients receiving moderately emetogenic cytostatic chemotherapy. The Granisetron Study Group.

The efficacy and safety of a novel anti-emetic, granisetron, was assessed at two dose levels (40 micrograms/kg; n = 223 and 160 micrograms/kg; n = 220) in a double-blind study in 443 patients undergoing treatment with a range of standard cytostatic therapies of which cyclophosphamide was the primary emetogenic agent for most patients. In the first 24 h, 76% of patients in the lower-dose group and 81% in the higher, experienced no vomiting and no, or only mild nausea (a complete response). Two additional doses of granisetron (40 microns/kg) were allowed on the first day to treat any symptoms of nausea and vomiting. This produced improvement or resolution of symptoms in 82% to 95% of patients. Over the 7 days of the study a complete response was maintained by 40% and 42% of patients, respectively. No differences in efficacy or safety between the two doses of granisetron were established. The commonest adverse event was headache, occurring in about 15% of patients. No extrapyramidal effects were observed. There was no relationship between the total dose and the number and severity of specific adverse events.