PWSC2-4 - Randomized Controlled Study Comparing Two Doses of Intravenous Granisetron Chemotherapy-Induced Nausea and Vomiting

Abstract

Objective: The aim of this study was to assess the non-inferiority of 1 mg to 3 mg granisetron injection for the treatment of acute chemotherapy-induced nausea and vomiting and to evaluate the tolerability of granisetron given at 1 mg in Japanese cancer patients.Methods: Patients with cancer receiving highly emetogenic chemotherapy were enrolled in this single-blind randomized controlled study. Patients were randomly assigned to receive granisetron at a single dose of 1 mg or 3 mg. The primary endpoint was the rate of complete protection from emetic events(no vomiting, no retching, and no need for rescue medication)during the first 24 hours following the initiation of chemotherapy.Results: There were 89 patients in the 1-mg group and 90 patients in the 3-mg group. Complete protection was achieved in 70 patients(78.7%) in the 1-mg group and 73(81.1%) patients in the 3-mg group. The one-sided test did not reveal non-inferiority of either dose of granisetron to the other at a 5.0% significance level.Conclusion: Our data failed to show the non-inferiority of 1 mg to 3 mg of granisetron administered as a single dose. However, the rate of complete protection from nausea and vomiting was similar in the two groups. Given the recommended dosage in the guidelines and the economic need for reduction of medical care expenses in Japan, prophylactic administration of granisetron at 1 mg may be an appropriate treatment alternative for acute chemotherapy-induced nausea and vomiting in cancer patients.