RANDOMIZED, DOUBLE-BLIND COMPARISON OF GRANISETRON VERSUS GRANISETRONPLUS PREDNISOLONE AS ANTIEMETIC PROPHYLAXIS DURING MULTIPLE-DAY CISPLATIN-BASED CHEMOTHERAPY

Ninety chemotherapy-naive cancer patients receiving cisplatin-based (g reater than or equal to 50 mg/m(2)) chemotherapy participated in a ran domized, double-blind, cross-over study comparing the safety and effic acy of granisetron (GRA) versus granisetron plus prednisolone (GRA + P RE). All patients received i.v. granisetron 3 mg and were randomly all ocated to oral prednisolone 50 mg or placebo prior to chemotherapy. At the subsequent cycle of chemotherapy, patients were crossed over to t he other antiemetic treatment. A complete response, defined as no emet ic episodes and no worse than mild nausea, was obtained in 63% in the GRA group and in 79% of the patients in the GRA + PRE group day 1 (P=0 .013). Complete response rates on days 1-3 were 16% vs 27% (P=0.251). Significantly less nausea and vomiting was seen with the combination i n the first 24 h after cisplatin (P=0.001 and P=0.0003) and during day s 1-3 (P=0.005 and 0.044), Patient preference was 51.5% for the combin ation and 26.5% for granisetron alone, whereas 22% had no preference ( P=0.0270). Adverse reactions were mild and comparable; headache and co nstipation were the ones most frequently reported. Prednisolone signif icantly improves the antiemetic effect of granisetron in patients rece iving cisplatin-based chemotherapy, but the study also emphasizes the poor complete protection rate in patients receiving multiple-day cispl atin-based chemotherapy.