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

This double-blind, double-dummy, randomized study compared the 24 h 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...

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Bibliographic Details
Published in:	Anti-cancer drugs Vol. 9; no. 5; p. 387
Main Authors:	Kleisbauer, J P, García-Girón, C, Antimi, M, Azevedo, M C, Balmes, H, Massuti-Sureda, B, Contu, A, Luque, A, Pellier, P
Format:	Journal Article
Language:	English
Published:	England 01-06-1998
Subjects:	Abdominal Pain - chemically induced Adolescent Adult Aged Antiemetics - adverse effects Antiemetics - therapeutic use Antineoplastic Agents - administration & dosage Antineoplastic Agents - adverse effects Antineoplastic Agents - therapeutic use Blood Urea Nitrogen Cisplatin - administration & dosage Cisplatin - adverse effects Cisplatin - therapeutic use Constipation - chemically induced Dose-Response Relationship, Drug Double-Blind Method Drug Therapy, Combination Female Follow-Up Studies Granisetron - adverse effects Granisetron - therapeutic use Headache - chemically induced Humans Leukopenia - chemically induced Male Methylprednisolone - adverse effects Methylprednisolone - therapeutic use Middle Aged Nitrogen - blood Treatment Outcome Vomiting - chemically induced Vomiting - drug therapy Vomiting - prevention & control
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Summary:	This double-blind, double-dummy, randomized study compared the 24 h 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/m2 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 variables: CR 78 versus 59% (p<0.001), no vomiting 80 versus 61% (p<0.001) and no nausea 74 versus 57% (p<0.002). Significantly more patients receiving the combination were free of any emetic symptoms (74 versus 54%, p<0.001). Significantly fewer patients receiving combination therapy also required rescue therapy with i.v. granisetron (12.2 versus 21.7%, p=0.026). During the follow-on period, complete response rates varied day by day from 50 to 71%. Both treatments were well tolerated, with constipation, abdominal pain and headache as the most frequent adverse events.
ISSN:	0959-4973
DOI:	10.1097/00001813-199806000-00003