A comparison of two dose levels of granisetron in patients receiving high-dose cisplatin. The Granisetron Study Group.

In this double-blind study, the efficacy and safety of a novel anti-emetic, granisetron, was assessed at two dose levels (40 micrograms/kg; n = 149 and 160 micrograms/kg; n = 147) in 296 patients undergoing high-dose cisplatin chemotherapy. In the first 24 h, 57% and 60% of patients, respectively, experienced no vomiting and no more than mild nausea. Two further doses of granisetron (40 micrograms/kg) were permitted in the first 24 h to treat breakthrough nausea and vomiting. This resulted in resolution or improvement of symptoms in 68-89% of patients. Over the 7-day study period, 53% of patients in the lower-dose group and 51% in the higher received no conventional anti-emetic therapy. No difference in efficacy or safety between the two doses of granisetron was established. Granisetron was well tolerated throughout the dose range of the study (40-240 micrograms/kg). The commonest adverse event was headache, seen in 13-16% of patients. In all cases this resolved spontaneously or responded to simple treatment.