A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO COMPARE THE EFFICACY AND SAFETY OF ONDANSETRON (GR38032F) PLUS DEXAMETHASONE WITH METOCLOPRAMIDE PLUS DEXAMETHASONE IN THE PROPHYLAXIS OF NAUSEA AND EMESIS INDUCED BY CARBOPLATIN CHEMOTHERAPY

A double-blind, parallel-group study in 189 ovarian cancer patients co mpared the efficacy of ondansetron 8 mg i.v. (OND) and metoclopramide 60 mg i.v. (MET) both in combination with dexamethasone 20 mg i.v. in the prevention of carboplatin-induced emesis. On day 1, complete or ma jor control of emesis (0-2 emetic episodes) was observed in 97% patien ts from the OND group compared with 74% patients from the MET group (p < 0.001). Similarly, a worst-day analysis over days 1-3 showed comple te or major control of emesis in 87% patients (OND) compared wth 66% p atients (MET) (p < 0.001). Similar findings in favour of the OND group were observed for nausea grade on day 1 and the worst-day grade durin g days 1-3. OND was better tolerated than MET. Fewer patients from the OND group (13%) reported adverse events compared with the MET group ( 21%). Extrapyramidal type symptoms were observed in 6 (6%) patients fr om the MET group (paraesthesia, involuntary movement of the jaw and to ngue, and restlessness), compared with none from the OND group. Ondans etron plus dexamethasone is a highly effective and well-tolerated trea tment and is significantly superior to metoclopramide plus dexamethaso ne in the prevention of carboplatin-induced emesis.