DOUBLE-BLIND, RANDOMIZED COMPARISON OF THE ANTIEMETIC EFFICACY OF INTRAVENOUS DOLASETRON MESYLATE AND INTRAVENOUS ONDANSETRON IN THE PREVENTION OF ACUTE CISPLATIN-INDUCED EMESIS IN PATIENTS WITH CANCER

Purpose: To assess the comparative antiemetic efficacy of single-dose intravenous (IV) dolasetron mesylate and ondansetron in preventing cis platin-induced nausea and vomiting. Patients and Methods: Cancer patie nts (n = 609) receiving first-course cisplatin chemotherapy were rando mized to one of three treatments: 1.8 or 2.4 mg/kg dolasetron mesylate salt (equivalent to 1.3 and 1.8 mg/kg dolasetron base, respectively) or 32 mg ondansetron. Each treatment was infused over 15 minutes, 30 m inutes before cisplatin administration. Patients were stratified to ci splatin doses of <greater than or equal to greater than or equal to 70 and less than 91 mg/m(2) (n = 368) or greater than or equal to 91 mg/ m(2) (n = 241), administered over less than or equal to 3 hours, proto col-defined efficacy criteria included complete response (zero emetic episodes and no rescue medication), major response (1 to 2 emetic epis odes and no rescue medication), and patients' report of nausea severit y and satisfaction recorded on a 100-mm visual analog scale (VAS). Res ults: The three treatments met protocol-specified criteria for equival ence, Complete response rates for dolasetron mesylate 1.8 mg/kg, 2.4 m g/kg, and ondansetron, respectively, were 49.2%, 45.6%, and 50.4% for patients in the lower cisplatin stratum (mean, 74.7 mg/m(2)) and 36.8% , 31.3%, and 31.8% in the higher cisplatin stratum (mean, 100.6 mg/m(2 )). No significant differences were observed in the extent of nausea w ith either dolasetron dose compared with ondansetron. Less nausea was noted with 1.8 mg/kg dolasetron compared with the 2.4 mg/kg dose (P = .044) All three antiemetic treatments were well tolerated. Asymptomati c electrocardiogram changes were recorded with both dolasetron and ond ansetron. Conclusion: A single IV dose of dolasetron mesylate (1.8 or 2.4 mg/kg) has comparable safety and efficacy to a single 32-mg IV dos e of ondansetron in patients receiving cisplatin chemotherapy. (C) 199 6 by American Society of Clinical Oncology.