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.
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Royal Marsden Hospital of London and Surrey, London, U.K.
D000970:Antineoplastic Agents / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D017829:Granisetron; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007191:Indazoles / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000188:drug therapy; D012702:Serotonin Antagonists / Q000008:administration & dosage*; D013997:Time Factors; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
D000970:Antineoplastic Agents; D017829:Granisetron; D007191:Indazoles; D012702:Serotonin Antagonists