Comparison of the anti-emetic efficacy of different doses of ondansetron, given as either a continuous infusion or a single intravenous dose, in acute cisplatin-induced emesis. A multicentre, double-blind, randomised, parallel group study

Abstract

Summary A total of 535 chemotherapy naive, hospitalised patients (263 male/272 female) scheduled to receive cisplatin (50-120mg m-2)-containing regimens participated in a randomised, double-blind, parallel group study to evaluate the efficacy and safety of three intravenous dose schedules of ondansetron in the prophylaxis of acute nausea and emesis. One hundred and eighty two patients received a loading dose of 8 mg of ondansetron followed by a 24 h infusion of 1 mg h-I (group 1); 180 and 173 patients received single doses of 32mg (group II) and 8 mg (group III) respectively, followed by a 24 h placebo infusion. Complete and major control ( < 2 emetic episodes) of acute emesis was achieved in 74% of patients in group I, 78% in group II and 74% in group III. Seventy seven per cent of the patients in group I, and 75% of patients in groups II and III respectively experienced no or mild nausea during the 24 h observation period. A retrospective stratification of the efficacy data on the basis of patient gender showed the response rate in females to be significant lower (43% vs 67%; <0.001). Ondansetron was well tolerated; mild headache was the most commonly reported adverse event (11 % of patients) with a similar incidence in the three groups of patients. In conclusion, a single intravenous dose of 8 mg of ondansetron given prior to chemotherapy is as effective as a 32 mg daily dose given as either a single dose or a continuous infusion in the prophylaxis of acute cisplatin-induced emesis.

Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control

“…However, due to cost considerations, many of these agents are often used at lower than optimal doses. In the U.S., the approved dose of intravenous ondansetron is 32 mg; however, ondansetron is frequently given at doses as low as 8 mg when administered as part of a combination treatment approach for moderately or highly emetogenic chemotherapy [59][60][61][62]. The impact of such a practice on symptom control may jeopardize effective patient management.…”

Methylprednisolone enhances the efficacy of ondansetron in acute and delayed cisplatin-induced emesis over at least three cycles

“…injection is as effective as a single 32 mg i.v. injection in the prevention of acute emetic episodes in patients receiving their first course of chemotherapy (Seynaeve et al, 1992). Similarly, it was demonstrated in another recent study that the antiemetic efficacy of ondansetron administered at a dose of 8 mg every 12 h in the prevention of the prolonged emesis seen after non-cisplatin chemotherapy is similar to the efficacy of a dose of 8 mg administered every 8 h (Dicato et al, 1992).…”

“…injection in patients following high-dose cisplatin-containing chemotherapy : Seynaeve et al, 1992: this success rate, 70% during the 24 h following chemotherapy, was also seen in the two following courses.…”

Comparative efficacy of a single oral dose of ondansetron and of buspirone against cisplatin-induced emesis in cancer patients

“…Intravenous ondansetron, given either in repeated doses or as a continuous infusion, antagonises vomiting associated with cisplatin treatment (Cubeddu et al, 1990;Beck et al, 1992;Seynaeve et al, 1992). These regimens have high pharmacy and nursing costs, and often lengthen the duration of hospitalisation.…”

“…dose with no loss of its antiemetic efficacy (Beck et al, 1992;Seynaeve et al, 1992). Although oral ondansetron has been used for non-cisplatin chemotherapies (Cubeddu et al, 1994), no information is available on whether oral ondansetron could control emesis associated with cisplatin treatment.…”