RANDOMIZED DOUBLE-BLIND COMPARISON OF 3 DOSE LEVELS OF INTRAVENOUS ONDANSETRON IN THE PREVENTION OF CISPLATIN-INDUCED EMESIS

The selective 5-hydroxytryptamine3 (5HT3) antagonist ondansetron has b een shown to be an effective antiemetic in patients receiving cisplati n chemotherapy. This double-blind study compared the efficacy and safe ty of three doses of intravenous ondansetron in the prevention of naus ea and vomiting associated with high-dose (greater-than-or-equal-to 10 0 Mg/M2) cisplatin chemotherapy. A total of 125 patients were randomiz ed (1 : 1 : 1) to receive 0.015, 0.15, or 0.30 mg/kg every 4 h for a t otal of 3 doses. All patients were monitored for emetic episodes, adve rse events, and laboratory safety parameters for 24 h following cispla tin administration. The 0.15-mg/kg dose was superior to the 0.015-mg/k g dose with respect to the median number of emetic episodes (P = 0.033 ) and complete response (no emetic episodes, P = 0.005). No statistica lly significant difference was found between the 0.15 and the 0.30-mg/ kg groups. The most common adverse event was headache. Three 0.15-mg/k g doses of intravenous ondansetron are safe, effective, and adequate f or the control of cisplatin-induced emesis.