A MULTICENTER, DOUBLE-BLIND, RANDOMIZED TRIAL COMPARING ONDANSETRON VERSUS ONDANSETRON PLUS DEXAMETHASONE IN THE PROPHYLAXIS OF CISPLATIN-INDUCED DELAYED EMESIS

The aim was to compare the efficacy of ondansetron and a combination o f ondansetron plus dexamethasone in the prophylaxis of cisplatin-induc ed delayed emesis over three consecutive courses of chemotherapy. Canc er patients scheduled to receive for the first time cisplatin (>50 mg/ m(2)) in combination with other cytotoxic agents, were recruited in a multicentre, randomised, double-blind study and treated with ondansetr on 8 mg i.v. and dexamethasone 20 mg i.v. Twenty-four hours after the start of chemotherapy, patients were randomised to treatment either wi th oral ondansetron 8 mg bd plus placebo on days 2-5 (group A) or with oral ondansetron 8 mg bd plus oral dexamethasone 8 mg bd on days 2-3, and 4 mg bd on days 4 and 5 (group B). Two hundred and thirty-six can cer patients were recruited into the study. Complete protection from d elayed vomiting/nausea in group A and group B was Obtained in 50/39% a nd in 63/42% of patients, respectively in the first course; in 55/34% and in 64/40% in the second and in 49/31% and 60/37% in the third. Log istic regression analysis reveals a statistically significant differen ce in incidence of emesis between the combination of ondansetron plus dexamethasone and ondansetron alone (P<0.05). The same model, however, shows no difference in incidence of nausea between the two treatment regimens. Ondansetron plus dexamethasone reduces the risk of delayed e mesis following cisplatin chemotherapy as compared to ondansetron alon e.