ORAL GRANISETRON ALONE AND IN COMBINATION WITH DEXAMETHASONE - A DOUBLE-BLIND RANDOMIZED COMPARISON AGAINST HIGH-DOSE METOCLOPRAMIDE PLUS DEXAMETHASONE IN PREVENTION OF CISPLATIN-INDUCED EMESIS

Patients and methods: Three anti-emetic treatment regimens were compar ed in 357 patients receiving cisplatin therapy (mean dose 81 mg/m2) in this double-blind randomized study. Regimens studied were i) graniset ron 1 mg bd orally for 7 days (granisetron alone); ii) gran 1 mg bd or ally for 7 days plus prophylactic dexamethasone (12 mg i.v.) on the fi rst day only (gran/dex); iii) metoclopramide (3 mg/kg i.v. loading dos e; 4 mg/kg i.v. infusion) plus dex (12 mg i.v.) on the first day follo wed by met 10 mg orally tds for a further 6 days (met/dex). Results: A t 24 hours, gran/dex was significantly superior to met/dex in terms of total anti-emetic control, defined as no nausea, no vomiting, no resc ue anti-emetic therapy, not withdrawn (54.7% gran/dex vs. 37.2% met/de x; P < 0.01). There was also a significant delay in time to onset of n ausea (P < 0.01) and vomiting (P < 0.01) following gran/dex compared w ith met/dex. Oral granisetron alone was as effective as met/dex in con trol of acute emesis in all parameters examined. There were no signifi cant differences between the three groups in the control of delayed na usea and vomiting. The most common adverse experiences in both granise tron groups were headache and constipation, both characteristic of 5-H T3 antagonists. Agitation, somnolence, diarrhoea and decreased appetit e were reported more frequently by the met/dex group. Conclusions: Ora l granisetron as a single agent is as effective as high doses of i.v. met/dex in preventing cisplatin-induced emesis. Oral granisetron in co mbination with a corticosteroid provides superior anti-emetic control to the met/dex regimen in patients undergoing highly emetogenic chemot herapy.