Oral granisetron--simple and effective: a preliminary report. The Granisetron Study Group

This randomised, double-blind, study was carried out in 930 patients in order to examine the efficacy and safety of oral granisetron in the dose range 0.25, 0.5, 1.0 and 2.0 mg twice daily. Oral granisetron was administered for either 7 or 14 days according to the chemotherapy regimen used. A total of 930 patients were enrolled into this study in order to be able to detect a difference of 15% between groups (80% power). The preliminary results showed that at 7 days efficacy was significantly greater for 1.0 mg b.d. (58.5%) than for 0.25 mg b.d. (43.7%) and indicated that, of the doses examined, the 1.0 mg b.d. dose was optimal in patients receiving moderately emetogenic chemotherapy. In agreement with this there were more withdrawals from the 0.25 and 0.5 mg groups due to lack of efficacy. The adverse events most frequently reported (in greater than 5% of patients) were constipation, headache, abdominal pain, fever, leucopenia and asthenia. The latter three are recognised side effects of the primary disease and of chemotherapy. The incidence of headache was similar to that seen in previous granisetron studies. Abdominal pain may have been related to constipation. The incidence of constipation (25.9%) was higher than that reported in previous granisetron studies but was not dose related. Thus oral granisetron at 1.0 mg twice daily is an effective antiemetic, offering a convenient dosing regimen without significant adverse events.