A Double-Blind, Randomized Study of Two Different Dosage Regimens of Intravenous Dolasetron in Patients Receiving High-Dose Cisplatin Chemotherapy

Abstract

This study compared the antiemetic efficacy and safety of two different intravenous (IV) dolasetron dosing regimens in patients receiving their first course of high-dose (≧80 mg/m2) cisplatin. Of 30 patients enrolled, 14 received a single IV dolasetron dose (0.6 mg/kg) before cisplatin and 16 received a multiple IV dose regimen (0.6 mg/kg x 3) given before and after cisplatin. Complete plus major responses were achieved by 71% (10/14) of patients who received single-dose dolasetron and by 50% (8/16) of those who received the multiple-dose regimen. Forty-three percent (6/14) of patients who received the single dose liad a complete response compared with 25% (4/16) who received multiple doses. Multiple doses resulted in less nausea at 24 hr following cisplatin; however, differences were not statistically significant. Both regimens were well tolerated, with mild headache (33%) and diarrhea (13%) the most common adverse events. This study demonstrated that a single 0.6-mg/kg dose of dolasetron given before chemotherapy provides equivalent antiemetic efficacy to three 0.6-mg/kg doses given before and after high-dose cisplatin chemotherapy; thus, there was no additional antiemetic benefit by using the multiple-dose regimen.