1218 Ondansetron (OND) suppository (SUP): An effective treatment in the prevention of chemotherapy-induced emesis

Abstract

OND is currently available in oral (po) and intravenous (iv) formulations for chemotherapy and radiotherapy-induced emesis, sup's will provide a useful alternative. Two multicentre, randomised, double-blind, parallel group studies compared the efficacy and safety of a 16 mg once a day (od) OND sup with (i) 8 mg OND iv followed by 8 mg twice daily (bd) OND po in cisplatin chemotherapy and (ii) 8 mg bd OND po in non–cisplatin chemotherapy. Four hundred and twenty-one patients were recruited into the cisplatin study and 406 into the non–cisplatin study. In the CISPLATIN study, 92% of patients experienced complete or major control of emesis (0 to 2 emetic episodes) on day 1 in the OND iv and po combined regimen compared with 87% of patients in the OND sup regimen. In the non-cisplatin study, 81% of patients experienced complete or major control of emesis on the worst day of days 1–3 in the 8 mg bd OND po regimen compared with 73% of patients in the 16 mg od OND sup regimen. The 90% confidence interval for the difference between the treatments for complete or major control in both studies showed that the sup regimen was equivalent to the other two OND regimens. The most frequently reported drug-related event was headache. In conclusion, these two studies showed that the ondansetron sup was effective and safe in the prevention of cytotoxic drug-induced emesis. OND is currently available in oral (po) and intravenous (iv) formulations for chemotherapy and radiotherapy-induced emesis, sup's will provide a useful alternative. Two multicentre, randomised, double-blind, parallel group studies compared the efficacy and safety of a 16 mg once a day (od) OND sup with (i) 8 mg OND iv followed by 8 mg twice daily (bd) OND po in cisplatin chemotherapy and (ii) 8 mg bd OND po in non–cisplatin chemotherapy. Four hundred and twenty-one patients were recruited into the cisplatin study and 406 into the non–cisplatin study. In the CISPLATIN study, 92% of patients experienced complete or major control of emesis (0 to 2 emetic episodes) on day 1 in the OND iv and po combined regimen compared with 87% of patients in the OND sup regimen. In the non-cisplatin study, 81% of patients experienced complete or major control of emesis on the worst day of days 1–3 in the 8 mg bd OND po regimen compared with 73% of patients in the 16 mg od OND sup regimen. The 90% confidence interval for the difference between the treatments for complete or major control in both studies showed that the sup regimen was equivalent to the other two OND regimens. The most frequently reported drug-related event was headache. In conclusion, these two studies showed that the ondansetron sup was effective and safe in the prevention of cytotoxic drug-induced emesis.