Double-blind comparative trial of oral ondansetron versus oral granisetronversus IV ondansetron in the prevention of nausea and vomiting associated with highly emetogenic preparative regimens prior to stem cell transplantation

The optimal management of transplantation preparative regimen-induced nause a and vomiting remains unknown. We conducted a Phase III double-blind study to determine the efficacy and costs of oral ondansetron versus oral granis etron versus IV ondansetron and PRN rescue antiemetics for the prevention/c ontrol of nausea and vomiting associated with high-dose chemotherapy or che moradiotherapy prior to stem cell transplantation. One hundred two patients were randomized to receive either 8 mg PO ondansetron every 8 hours, 1 mg PO granisetron every 12 hours, or 32 mg IV ondansetron every 24 hours plus 10 mg IV dexamethasone daily during and I day after the various preparative regimens. Study arms were compared in terms of emetic episodes, subjective nausea, amount and cost of rescue antiemetics used, and total costs. Respo nse was defined as complete response (CR), no emesis with no or mild nausea and no rescue antiemetics; major response (MR), 1 episode of emesis or mod erate nausea with or without rescue antiemetics; and major efficacy (ME), C R + MR. Subjective nausea was assessed using a 100-mm visual analog scale ( VAS) with 0 = no nausea. Ninety-six patients completed the study; the trial was analyzed according to intention-to-treat Overall CR rates were: 48% fo r oral ondansetron, 47% for oral granisetron, and 49% for IV ondansetron. O verall ME rates were 82% for oral ondansetron, 84% for oral granisetron, an d 81% for IV ondansetron. Mean VAS scores were 32 for oral ondansetron, 32 for oral granisetron, and 27 for IV ondansetron. None of the differences we re statistically significant. A cost analysis revealed significant differen ces among all arms (P =.0001, all comparisons). All 3 regimens had similar efficacy in this BMT population; oral ondansetron was the most cost-effecti ve.