Efficacy of Intravenous Granisetron to Control Nausea and Vomiting During Multiple Cycles of Cisplatin-Based Chemotherapy

Abstract

The safety and efficacy of granisetron (10 µg/kg and 40 µg/kg) were evaluated during a second (n = 393) and third (n = 200) cycle of chemotherapy in this multicenter, double-blind, randomized, parallel-group study. Granisetron was administered as a single intravenous dose before the start of cisplatin chemotherapy (≥60 mg/m²). Total control (no vomiting, no retching, no nausea, and no use of antiemetic rescue medication) after the first 24 hr following chemotherapy was achieved in 40% and 49% of patients in Cycles 2 and 3, respectively, for the 10 µg/kg group, and in 42% and 38% of patients in Cycles 2 and 3, respectively, for the 40 µg/kg group. Both dose levels of granisetron were well tolerated. The results demonstrate comparable efficacy between the 10 µg/kg and 40 µg/kg doses of granisetron in preventing nausea and vomiting during repeat cycles of high-dose cisplatin-based chemotherapy. The results of this study show that granisetron 10 µg/kg is safe and well tolerated, and remains effective with repeat cycle use.