Multicenter, randomized trial of ramosetron plus dexamethasone versus ramosetron alone in controlling cisplatin-induced emesis.

GOALS

To establish whether the combination of a corticosteroid (dexamethasone) and the newer serotonin-3 (5-HT(3)) receptor antagonist ramosetron is superior to ramosetron alone in controlling cisplatin-induced emesis.

PATIENTS AND METHODS

A total of 283 patients aged 18-75 years with confirmed malignant disease who were scheduled to receive cisplatin > or =50 mg/m(2) with or without other antineoplastic agents were randomized to intravenous treatment with either ramosetron 300 microg plus dexamethasone 20 mg ( n=149) or ramosetron 300 microg alone ( n=134) given 30 min prior to cisplatin infusion. If vomiting occurred in the following 24 h, patients in both groups received an intravenous rescue dose of ramosetron 300 microg. Subsequently, on days 2 and 3, treatment was continued orally with either ramosetron 100 microg once daily plus dexamethasone 8 mg twice daily, or ramosetron 100 microg once daily.

MAIN RESULTS

During the first 24 h after cisplatin infusion, significantly more patients receiving combination therapy had a complete response (no nausea or vomiting or requirement for rescue therapy) than those receiving ramosetron alone (68% vs 54%, respectively; P=0.034), and significantly fewer patients needed a rescue dose of ramosetron (22% vs 34%, respectively; P=0.032). In addition, the percentages of patients with no nausea and no vomiting were significantly greater in the ramosetron plus dexamethasone group than in the ramosetron-alone group at both 24 h and 72 h after cisplatin administration.

CONCLUSIONS

The antiemetic efficacy of ramosetron in cancer patients receiving highly emetogenic cisplatin chemotherapy is significantly enhanced by its use in combination with dexamethasone.