Randomized, double-blind comparison of granisetron versus granisetron plus prednisolone as antiemetic prophylaxis during multiple-day cisplatin-based chemotherapy.

Ninety chemotherapy-naive cancer patients receiving cisplatin-based (> or = 50 mg/m2) chemotherapy participated in a randomized, double-blind, cross-over study comparing the safety and efficacy of granisetron (GRA) versus granisetron plus prednisolone (GRA + PRE). All patients received i.v. granisetron 3 mg and were randomly allocated to oral prednisolone 50 mg or placebo prior to chemotherapy. At the subsequent cycle of chemotherapy, patients were crossed over to the other antiemetic treatment. A complete response, defined as no emetic 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 in the first 24 h after cisplatin (P = 0.001 and P = 0.0003) and during days 1-3 (P = 0.005 and 0.044). Patient preference was 51.5% for the combination and 26.5% for granisetron alone, whereas 22% had no preference (P = 0.0270). Adverse reactions were mild and comparable; headache and constipation were the ones most frequently reported. Prednisolone significantly improves the antiemetic effect of granisetron in patients receiving cisplatin-based chemotherapy, but the study also emphasizes the poor complete protection rate in patients receiving multiple-day cisplatin-based chemotherapy.