Granisetron plus methylprednisolone for the control of high-dose cisplatin-induced emesis

This double-blind,double-dummy,randomized study compared the 24h efficacy and safety of granisetron alone (3 mg i.v. over 30 s) or in combination with methylprednisolone (250 mg I.v. twice daily) in preventing nausea and vomiting in 308 patients (254 males) receiving high-dose cisplatin (100 mg/m or above) for mainly lung, and head and neck cancers. All patients received oral follow-on therapy comprising oral granisetron and methylprednisolone during the following 6 days. Primary efficacy variables were the proportions of complete responses (CR; no vomiting, no worse than mild nausea, no rescue and no withdrawal), no vomiting and no nausea over the first 24 h following initiation of the cisplatin Infusion. The two treatment groups were well matched for demographics, cancer site, cisplatin dose and duration of Infusion. Granisetron plus methylprednisolone was significantly more effective than granisetron alone for all primary efficacy variablesCR 78 versus 59% (p