ANTIEMETIC EFFICACY OF 2 DIFFERENT SINGLE INTRAVENOUS DOSES OF DOLASETRON IN PATIENTS RECEIVING HIGH-DOSE CISPLATIN-CONTAINING CHEMOTHERAPY

This randomized, double-blind, parallel-group, multicenter study compa red the antiemetic effectiveness, safety, and tolerability of two diff erent intravenous (i.v.) doses of dolasetron mesylate (0.6 and 1.8 mg/ kg) in cancer patients receiving their first course of high-dose cispl atin-containing chemotherapy (greater than or equal to 75 mg/m(2)). Ef ficacy was assessed by recording the timing, number, and severity of e metic episodes in the 24 h following high-dose cisplatin. Safety was e valuated by monitoring adverse events, vital signs, clinical laborator y parameters, and electrocardiograms. Of the 62 patients enrolled in t he study, 29 received 0.6 mg/kg of dolasetron mesylate and 33 received 1.8 mg/kg. Patients who received dolasetron mesylate 1.8 mg/kg consis tently experienced a greater degree of antiemetic control than those w ho received 0.6 mg/kg. Complete responses were achieved by 55% of pati ents who received 1.8 mg/kg compared with 31% for the 0.6-mg/kg group. The 1.8-mg/kg group achieved a significantly (p = 0.039) higher compl ete/major response rate than the 0.6-mg/kg group (77% vs 55%, respecti vely) and a significantly (p = 0.004) longer time to the first emetic episode (>24 h vs 13.5 h, respectively). More than 80% of patients wer e either satisfied or very satisfied with dolasetron treatment. The mo st common adverse events were mild to moderate in intensity, consisten t with other studies and included headache (24.1% of patients) and dia rrhea (4.8%). These results demonstrated that a single 1.8-mg/kg i.v. dose of dolasetron mesylate provided effective antiemetic activity in a majority of patients given high-dose cisplatin for the first time an d should be evaluated further in clinical trials.