SINGLE-DOSE ORAL GRANISETRON HAS EQUIVALENT ANTIEMETIC EFFICACY TO INTRAVENOUS ONDANSETRON FOR HIGHLY EMETOGENIC CISPLATIN-BASED CHEMOTHERAPY

Purpose: To compare the antiemetic efficacy of a single dose of an ora l antiemetic (granisetron 2 mg) with a single dose of an intravenous ( IV) antiemetic (ondansetron 32 mg) given before cisplatin-based chemot herapy, Patients and Methods: This was a multicenter, randomized,doubl e-blind. parallel-group study, Patients (N = 1,054) scheduled to recei ve cisplatin (greater than or equal to 60 mg/m(2))based chemotherapy w ere randomized to receive either 2 mg of oral granisetron tablets 1 ho ur before chemotherapy (n = 534) or IV ondansetron (32 mg) 30 minutes before chemotherapy (n = 520). The primary efficacy end point was tota l control (no emesis, no nausea, and no use of antiemetic rescue medic ation) over the initial 24 hours after the start of chemotherapy, Dexa methasone or methylprednisolone were permitted, but not required, as c oncomitant prophylactic antiemetics, Results: Total control was equiva lent 24 hours after cisplatin chemotherapy for single-dose oral granis etron (54.7%) and IV ondansetron (58.3%) (95% confidence interval [Cl] , -9.6 to 2.4), Similar proportions of patients remained nausea-free i n the granisetron group (55.4%) and the ondansetron group (59%) (95% C l, -9.6 to 2.4). The rate of complete control of emesis was 61.2% in t he granisetron group and 67.1% in the ondansetron group (95% Cl, -11.7 to -0.1), Both treatment regimens were well tolerated, with similar p atterns of adverse reactions, generally of a mild degree, The most com mon side effects included constipation (14%), headache (15%), and diar rhea (10%). Conclusion: Oral granisetron, administered as a single 2-m g dose, provided equivalent total antiemetic control when compared wit h IV ondansetron (32 mg) in patients who received highly emetogenic, c isplatin-based chemotherapy. (C) 1998 by American Society of Clinical Oncology.