Ondansetron, a 5-HT3 receptor antagonist, has been shown to be effective antiemetic agent in the control of cisplatin-induced emesis. We conduced a randomized trial comparing antiemetic effect of ondansetron and
MDL(metoclopramide/dexamethasone/lorazepam) in patients receiving their firs course of combination chemotherapy containing cisplatin(60mg/m*).
Ondansetron(8mg) was given intravenously(i.v.) 15 min before cisplatin and then 4 hours and 8 hours after cisplation on 1, and p.o. every 8 hours from day 2 to 5. In the MDL group, metoclopramide(2 mg/kg) was given i.v. 30 min before and 90 min
after
cisplatin, dexamethasone(20mg) i.v. 40min before cisplatin, and lorazepam(1mg) i.v. 45 min before cisplatin on day 1. From day 2 to 5, metocloparamide(10mg) was give p.o. every 6 hours, and dexamethasone was given p.o. every 12 hours at a dose
of
8mg
on day 2-3 and at a dose of 4 mg on day 4-5 Among 104 patients, 3 patients were excluded from the analysis due to protocol violations. The control of emesis was graded in the following way: complete control(CR), no vomiting; nearly complete
control(nCR), 1-2 emetic episodes. For actue emesis, major control(complete and nearly complete control) was achieved in 39 of 51 patients(76.4%) with ondansetron and in 43 of 50 patients(86%) with MDL(p=0.22). For delayed emesis, major control
achieved
in 30 of 51 patients(58.8%) with ondansetron and in 40 of 50 patients(80%) with MDL(p=0.02).
In the ondansetron group, mild headache(25%) was frequently observed but no sedation or extrapyramidal side-effects were see. In contrast, in the MDL group, sedation(34%), hiccups(22%), and insomnia(18%) were frequently observed and
extrapyramidal
side-effects were seen in one patient.
In conclusion, ondansetron was as effective as MDL combination antiemetics in controlling the acute emesis without neurologic side-effects, but ondansetron was less effective in controlling delayed emesis.
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