ONDANSETRON SUPPOSITORY - AN EFFECTIVE TREATMENT FOR THE PREVENTION OF EMETIC DISORDERS INDUCED BY CISPLATIN-BASED CHEMOTHERAPY

This multicentre, randomised, double-blind, double-dummy, parallel gro up study was investigated in order to compare on 3 days the efficacy a nd the safety of the 16 mg once a day (od) ondansetron suppository (su ppository group) with the recommended ondansetron treatment, i.e. 8 mg intravenous (I.V.) ondansetron on day 1 followed by 8 mg tablet (p.o. ) twice daily (i.v. + p.o. group) on days 2 and 3 in patients receivin g cisplatin (greater than or equal to 50 mg/m(2)) containing chemother apy. In the 420 patients included in the intent-to-treat population, 2 09 received the 16 mg suppository and 211 the i.v. + p.o. treatment. T he number of emetic episodes and the nausea score were recorded each d ay. Concerning the primary criterion, bath treatments provided good an ti-emetic control with 87% of all patients having a complete or major response (0-2 emetic episodes) on day 1 in the suppository group and 9 2% in the i.v. + p.o. group (P = 0.058). The 90% confidence interval f or the difference between the two treatments for complete or major con trol was included in the interval (-15%, 15%) and showed that the trea tment groups could be regarded as equivalent. Small differences in fav our of the i.v. + p.o. group were observed concerning the secondary pa rameters. Both treatments were well tolerated. The results of this stu dy show that both treatments are equivalent in the prevention of cispl atin-containing chemotherapy induced emesis for the primary efficacy c riteria and that the ondansetron suppository is efficient and well tol erated and is a suitable alternative to the anti-emetic treatment comb ining the intravenous and oral routes. (C) 1997 Elsevier Science Ltd.