A randomized, double-blind, multicentre study comparing daily 2 and 5 mg of tropisetron for the control of nausea and vomiting induced by low-dose cisplatin- or non-cisplatin-containing chemotherapy

Background: This study compares efficacy safety and tolerability of 2 and 5 mg tropisetron in prevention of nausea and vomiting induced by low-dose cisplatin- or non-cisplatin-containing chemotherapy. Patients and methods: 152 chemotherapy-naive cancer patients were randomized in a double-blind manner to receive 2 or 5 mg tropisetron intravenously day 1 and orally days 2-6. Primary efficacy criteria were control of acute (day 1) and delayed (days 26) vomiting and nausea. Secondary efficacy criteria included overall control (days 1-6) and control of vomiting and nausea by chemotherapy regimen. Safety and tolerability were evaluated clinically, biochemically and by the patient's diary. Only the first cycle was evaluated. Results: 124 of the 144 intention-to-treat patients were evaluable. There was a better total control (no events) of acute vomiting in the 5 mg (73%) than in the 2 mg group (55%, P = 0.02). Total control (less than or equal to 15 minutes) of acute nausea was obtained in 70% of the 5 mg group and in 51% of the 2 mg (P = 0.03). No differences were observed for total control of delayed nausea or vomiting and for the overall outcome of nausea. Less vomiting (days 1-6) occurred in the 5 mg than in the 2 mg group. Efficacy rates ranged widely between chemotherapy regimens, independent of the tropisetron dose groups. There occurred more headache in the 5-mg group (P <0.05). Conclusions: Once daily 5 mg tropisetron is superior to 2 mg for prevention of acute vomiting and nausea induced by low-dose cisplatin- or non-cisplatin chemotherapy regimens, but causes more headache