A DOUBLE-BLIND, RANDOMIZED STUDY OF 2 DIFFERENT DOSAGE REGIMENS OF INTRAVENOUS DOLASETRON IN PATIENTS RECEIVING HIGH-DOSE CISPLATIN CHEMOTHERAPY

This study compared the antiemetic efficacy and safety of two differen t intravenous (IV) dolasetron dosing regimens in patients receiving th eir first course of high-dose (greater than or equal to 80 mg/m(2)) ci splatin. Of 30 patients enrolled, 14 received a single IV dolasetron d ose (0.6 mg/kg) before cisplatin and 16 received a multiple IV dose re gimen (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 mul tiple-dose regimen. Forty-three percent (6/14) of patients who receive d the single dose had 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 no statistically si gnificant. Both regimens were well tolerated, with mild headache (33%) and diarrhea (13%) the most common adverse events. This study demonst rated that a single 0.6-mg/kg dose of dolasetron given before chemothe rapy provides equivalent antiemetic efficacy to three 0.6-mg/kg doses given before and after high-dose cisplatin chemotherapy; thus, there w as no additional antiemetic benefit by using the multiple-dose regimen .