EFFICACY OF INTRAVENOUS GRANISETRON TO CONTROL NAUSEA AND VOMITING DURING MULTIPLE CYCLES OF CISPLATIN-BASED CHEMOTHERAPY

The safety and efficacy of granisetron (10 mu g/kg and 40 mu g/kg) wer e evaluated during a second (n = 393) and third (n = 200) cycle of che motherapy in this multicenter double-blind, randomized, parallel-group study. Granisetron was administered as a single intravenous dose befo re the start of cisplatin chemotherapy (greater than or equal to 60 mg /m(2)). Total control (no vomiting, no retching, no nausea, and no use of antiemetic rescue medication) after the first 24 hr following chem otherapy was achieved in 40% and 49% of patients in Cycles 2 and 3, re spectively for the 10 mu g/kg group, and in 42% and 38% of patients in Cycles 2 and 3, respectively for the 40 mu g/kg group. Both dose leve ls of granisetron were well tolerated The results demonstrate comparab le efficacy between the 10 mu g/kg and 40 mu g/kg doses of granisetron in preventing nausea and vomiting during repeat cycles of high-dose c isplatin-based chemotherapy. The results of this study show that grani setron 10 mu g/kg is safe and well tolerated and remains effective wit h repeat cycle use.