COMPARATIVE CROSSOVER TRIAL OF 2 INTRAVENOUS DOSES OF GRANISETRON (1 MG VS 3 MG) PLUS DEXAMETHASONE IN THE PREVENTION OF ACUTE CIS-PLATINUM-INDUCED EMESIS

Background: The 5HT3 receptor antagonist Granisetron (GRA) is availabl e on the market as a I mg vial in USA and as a 3 mg vial in Europe. Th is study aimed to compare the two i.v. doses of GRA (3 mg vs 1 mg), bo th of which combined with Dexamethasone (DEX) (20 mg) in the preventio n of acute Cisplatinum (CP)-induced emesis. Patients and Methods: One hundred and ninety-eight consecutive chemotherapy-naive cancer patient s, mainly suffering from lung and bladder cancer were randomized at th eir first cycle to receive either GRA I mg + DEX or GRA 3 mg + DEX as i.v. bolus prior to chemotherapy and crossed-over to another GRA dose at the second cycle. The cytotoxic treatment included different multi- drug regimens containing CP (median dose 60 mg/m(2) range 50-70) admin istered on day 1 and repeated every 21-28 days. Results: Of the 192 ev aluable patients complete protection from acute emesis with GRA I and GRA 3, was observed after the 1st + 2nd cycles as follows: nausea 70% and 74%, vomiting 90% and 94%, nausea and vomiting 67% and 74% respect ively (no statistically significant difference). No carry-over effect was observed on the complete protection from emesis. The crossover ana lysis comprising 156 patients confirmed there were no differences betw een the two antiemetic treatments. Twenty-seven per cent of patients p referred GRA 1, 31% preferred GRA 3, while 42% expressed no preference (P=0.75). Nor was any difference observed for tolerability, the only reported side- effects being mild headache (16% vs 17%) and constipati on (18% vs 25%). Conclusion: This study shows that, under the above co nditions, the I mg and 3 mg i.v. GRA doses are comparably effective wh en combined with DEX 20 mg in the prevention of acute CP-induced emesi s.