ONDANSETRON COMPARED WITH GRANISETRON IN THE PROPHYLAXIS OF CISPLATIN-INDUCED ACUTE EMESIS - A MULTICENTER DOUBLE-BLIND, RANDOMIZED, PARALLEL-GROUP STUDY

This is the first international, multi-centre, double-blind, randomise d, parallel group study to directly compare the efficacy and safety pr ofile of a single intravenous dose of ondansetron (8 or 32 mg) with gr anisetron (3 mg) in the control of cisplatin-induced acute emesis. A t otal of 496 patients were randomised to receive one of three anti-emet ic treatments prior to cisplatin chemotherapy ( greater than or equal to 50 mg/m(2)). Of these, 165 and 162 patients received 8 and 32 mg of ondansetron, respectively, and 169 patients received 3 mg of graniset ron. Complete control of emesis (0 emetic episodes) over 24 h was repo rted in 59% of patients in the 8-mg ondansetron group, 51% of patients in the 32-mg ondansetron group and 56% of patients in the granisetron group. Complete or major control ( less than or equal to 2 emetic epi sodes) was achieved in 76 and 74% of patients in the 8- and 32-mg onda nsetron group, respectively compared with 78% of patients in the grani setron group. Nausea graded none or mild 24 h after the start of cispl atin infusion was reported in 71 and 69% of patients in the 8- and 32- mg ondansetron groups, respectively, and in 73% of patients in the gra nisetron group. There were no significant differences between the trea tment groups when global satisfaction scores were compared. Logistic r egression models were fitted to assess any interaction between treatme nts and prognostic factors (age, gender, alcohol use, cisplatin dose o r concomitant chemotherapy) on complete or major response, but there w as no evidence of interaction for any factor. Ah three anti-emetic tre atments were well tolerated and no severe or unexpected drug-related a dverse events were observed with ondansetron or granisetron. Headache, the most reported drug-related adverse event for all three treatment groups, occurred in 9% of all patients. In summary, no significant dif ference was observed between any of the treatment groups with respect to emesis, nausea or drug-related adverse events.