PREVENTION OF HIGHLY EMETOGENIC CHEMOTHERAPY-INDUCED VOMITING - A DOUBLE-BLIND, RANDOMIZED CROSSOVER STUDY TO COMPARE PANCOPRIDE (LAS-30451) AND PANCOPRIDE PLUS DEXAMETHASONE

Aims Pancopride (PNC) is a new 5HT3 receptor antagonist which has demo nstrated complete protection from nausea and vomiting in 25-73% of pat ients treated with highly emetogenic chemotherapy. A double-blind, ran domized crossover study was carried out to assess whether the addition of dexamethasone (DXM) to PNC increases the antiemetic efficacy. Meth ods: PNC (0.2 mg/kg, i,v, 30 min before chemotherapy) plus placebo (PL C) was compared with PNC (same dose and schedule) plus DXM (20 mg, i.v . immediately before PNC), In the second cycle, patients received the alternative antiemetic treatment. Eighty patients were included in the study (PNC+DXM=39, PNC+PLC=41), 29 of whom were women and 51 men, Fif ty-four percent of the patients in the PNC+DXM group and 59% of those in the PNC+PLC group received chemotherapy containing cisplatin. Seven ty-seven patients completed the first cycle and 70 the second, Results : Complete protection was obtained in 19/16 patients (50/46%) with PNC +PLC and in 32/22 (82/63%) with PNC+DXM (P<0,001), Latency was signifi cantly longer in the PNC+DXM group. The efficacy of both treatments wa s unaffected by the order of administration, Side effects were mild in both groups. Conclusions: The combination of PNC+DXM is more efficaci ous than PNC+PLC in protection against highly emetogenic chemotherapy- induced vomiting.