GRANISETRON PLUS METHYLPREDNISOLONE FOR THE CONTROL OF HIGH-DOSE CISPLATIN-INDUCED EMESIS

This double-blind, double-dummy, randomized study compared the 24 h ef ficacy and safety of granisetron alone (3 mg i.v. over 30 s) or in com bination with methylprednisolone (250 mg i.v. twice daily) in preventi ng nausea and vomiting in 308 patients (254 males) receiving high-dose cisplatin (100 mg/m(2) or above) for mainly lung, and head and neck c ancers. All patients received oral follow-on therapy comprising oral g ranisetron 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 th e cisplatin infusion. The two treatment groups were well matched for d emographics, cancer site, cisplatin dose and duration of infusion. Gra nisetron plus methylprednisolone was significantly more effective than granisetron alone for all primary efficacy variables: CR 78 versus 59 % (p<0.001), no vomiting 80 versus 61% (p<0.001) and no nausea 74 vers us 57% (p<0.002). Significantly more patients receiving the combinatio n were free of any emetic symptoms (74 versus 54%, p<0.001). Significa ntly fewer patients receiving combination therapy also required rescue therapy with i.v. granisetron (12.2 versus 21.7%, p=0.026). During th e follow-on period, complete response rates varied day by day from 50 to 71%. Both treatments were well tolerated, with constipation, abdomi nal pain and headache as the most frequent adverse events. [(C) 1998 L ippincott-Raven Publishers.].