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

Abstract

The optimal management of transplantation preparative regimen-induced nausea and vomiting remains unknown. We conducted a Phase III double-blind study to determine the efficacy and costs of oral ondansetron versus oral granisetron versus IV ondansetron and PRN rescue antiemetics for the prevention/control of nausea and vomiting associated with high-dose chemotherapy or chemoradiotherapy 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 1 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. Response 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 moderate nausea with or without rescue antiemetics; and major efficacy (ME), CR + 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% for oral ondansetron, 47% for oral granisetron, and 49% for IV ondansetron. Overall ME rates were 82% for oral ondansetron, 84% for oral granisetron, and 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 were statistically significant. A cost analysis revealed significant differences among all arms (P = .0001, all comparisons). All 3 regimens had similar efficacy in this BMT population; oral ondansetron was the most cost-effective.

Ondansetron and Granisetron in Prophylaxis of Nausea and Emesis Inducedby Cisplatin in Dogs

“…These results match those of studies with human beings receiving cisplatin (Upward et.al.1990;Spector et al 1998;Fox-Geiman et al 2001;Goodin and Cunningham 2002;Minami 2003) and the clinical profiles of these agents in the treatment of cisplatin-induced emesis (Goodin and Cunningham 2002;Navari 2003;Schnell 2003). Moreover, granisetron was more effective than ondansetron in reducing the nausea episodes induced by cisplatin.…”

The efficacy of oral ondansetron and dexamethasone for the prevention of acute chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy - a retrospective audit

“…Oral anti-emetics are more convenient to administer especially in the outpatient treatment setting as this requires less nursing time (preparation and administration) and also reduces the patient's time spent in the ambulatory chemotherapy unit (as intravenous antiemetics should be given 30 min prior to chemotherapy treatment). The use of oral 5HT3-antagonist has also been shown to be more cost-effective than intravenous 5HT3antagonist (Fox-Geiman et al 2001;McCune et al 2001). In Australia, a single dose of oral ondansetron (8 mg/ tablet) costs approximately one-third of the intravenous preparation (8 mg/vial) (Commonwealth of Australia 2007).…”

Palonosetron (Aloxi®) and dexamethasone for the prevention of acute and delayed nausea and vomiting in patients receiving multiple-day chemotherapy

“…However, the control of delayed CINV [1,14,19,27,29] is still an open problem, especially in patients undergoing multiple-day [5,10,11,24,31] or high-dose (HD) CT [3,4,7,12,22,28,32]. Patients treated with multiple-day CT regimens are at risk for CINV throughout the entire treatment period.…”