COMPARATIVE CLINICAL-TRIAL OF GRANISETRON AND ONDANSETRON IN THE PROPHYLAXIS OF CISPLATIN-INDUCED EMESIS

Purpose: To compare the efficacy and safety of granisetron and ondanse tron, serotonin (5-HT3) receptor antagonists shown to be effective in the prevention of chemotherapy-induced emesis. Patients and Methods: I n a double-blind, randomized, stratified, parallel-group study, the ef ficacy and safety of granisetron and ondansetron were compared in 987 chemotherapy-naive patients who received cisplatin in doses greater th an or equal to 60 mg/m(2). Granisetron was administered as a single do se of 10 or 40 mu g/kg before the start of chemotherapy, Ondansetron w as administered in doses of 0.15 mg/kg before and 4 and 8 hours after the start of chemotherapy. The three treatment groups were well-matche d with respect to demographic characteristics and the dose of cisplati n administered. Results: For all evaluations, single doses of graniset ron 10 or 40 mu g/kg were as effective as three 0.15-mg/kg doses of on dansetron. Total control (no vomiting, no retching, no nausea, and no use of rescue) was attained by 38%, 41%, and 39% of all patients who r eceived granisetron 10 mu g/kg, granisetron 40 mu g/kg, and ondansetro n, respectively, No vomiting or retching and no use of rescue antiemet ics were reported in 47%, 48%, and 51% of patients who received granis etron 10 mu g/kg, granisetron 40 mu g/kg, and ondansetron, respectivel y; no nausea and no use of rescue antiemetics were reported in 39%, 42 %, and 40% of patients, respectively. Conclusion: All three treatment regimens were well-tolerated, The results of this study indicate that a single dose of granisetron 10 or 40 mu g/kg is as effective as three doses of ondansetron 0.15 mg/kg in the prevention of nausea and vomit ing induced by cisplatin chemotherapy. (C) 1995 by American Society of Clinical Oncology.