A DOUBLE-BLIND, RANDOMIZED COMPARISON OF THE ANTIEMETIC EFFICACY OF 2INTRAVENOUS DOSES OF DOLASETRON MESILATE AND GRANISETRON IN PATIENTS RECEIVING HIGH-DOSE CISPLATIN CHEMOTHERAPY

This multicentre, double-blind, double-dummy, randomised trial was des igned to compare the efficacy and safety of single intravenous doses o f dolasetron mesilate and granisetron in the prevention of acute emesi s and nausea due to high-dose (greater than or equal to 80 mg/m(2)) ci splatin. Single intravenous doses of 1.8 or 2.4 mg/kg of dolasetron me silate or 3 mg of granisetron hydrochloride were administered in a vol ume of 50 mi over a 5-min period, beginning 30 min prior to cisplatin (greater than or equal to 80 mg/m(2)) administration. The number and t iming of emetic episodes, time to administration of escape anti-emetic medication, severity of nausea by visual analogue scale (VAS), and sa fety were monitored for 24 h after the start of cisplatin-containing c hemotherapy. Investigators) evaluations of overall efficacy and patien ts' satisfaction with therapy were recorded at the end of the 24-h stu dy period. Of the 474 patients evaluable for efficacy, complete respon ses were achieved by 54, 47 and 48% of patients given dolasetron mesil ate 1.8 mg/kg, dolasetron mesilate 2.4 mg/kg and granisetron, respecti vely. Statistically, treatment groups had comparable complete and comp lete plus major responses, times to first emesis, and use of escape me dication; patient maximum nausea severity and treatment satisfaction r atings; and physician nausea severity and overall efficacy assessments . For the majority of efficacy endpoints, 1.8 mg/kg dolasetron mesilat e produced numerically superior responses compared with the 2.4 mg/kg dose. Gender and prior chemotherapy were significant predictors of com plete response; males and chemotherapy-naive patients had higher respo nses. The overall incidences of adverse events were comparable among t he treatment groups; headache and diarrhoea were most common. In concl usion, 1.8 and 2.4 mg/kg of dolasetron mesilate and granisetron (3 mg) were equally effective in preventing nausea and vomiting induced by h ighly emetogenic cisplatin-containing chemotherapy. In addition, becau se no additional benefit was observed with 2.4 mg/kg of dolasetron mes ilate and numerically greater responses were observed with the 1.8 mg/ kg dose, the lower dose of 1.8 mg/kg is optimal for further clinical d evelopment. Copyright (C) 1996 Elsevier Science Ltd