RANDOMIZED PHASE-II TRIAL COMPARING 2 VERSUS 3 DOSES OF ONDANSETRON WHEN USED IN COMBINATION WITH DEXAMETHASONE IN PATIENTS RECEIVING CISPLATIN GREATER-THAN-OR-EQUAL-TO-100MG M(2)/

Ondansetron controls cisplatin-induced emesis when given in three 0. 1 5 mg/kg doses, and preliminary data suggest that control may be mainta ined when fewer doses are employed. Prior trials have further shown im proved antiemetic effects and fewer adverse effects of cisplatin treat ment when neurotransmitter receptor blockers are combined with dexamet hasone. This trial was undertaken to determine the effectiveness of th e combination of dexamethasone and ondansetron and to see if equivalen t results could be obtained with only two doses of ondansetron. There were 44 patients receiving initial cisplatin at a dose greater-than-or -equal-to 100 Mg/M2 , each given dexamethasone 20 mg and randomized to receive either two or three 0. 15 mg/kg doses of ondansetron. Vomitin g prevention was identical (35%) whether two or three doses were given . No new adverse effects were noted and cisplatin-induced diarrhea, us ually seen in up to 60% of patients given this dose of cisplatin, was noted in only 5%. Although this trial did not demonstrate enhanced ant iemetic effects with the combination, other investigators have done so and all agree that the regimen is safe and reduces adverse effects. F urther exploration and use of the combination of ondansetron and dexam ethasone, and studies testing fewer doses of ondansetron in this regim en are warranted.