A RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY COMPARING DAILY 2-MG AND 5-MG OF TROPISETRON FOR THE CONTROL OF NAUSEA AND VOMITING INDUCED BY LOW-DOSE CISPLATIN-CONTAINING 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 l ow-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 a cute (day 1) and delayed (days 26) vomiting and nausea. Secondary effi cacy criteria included overall control (days 1-6) and control of vomit ing and nausea by chemotherapy regimen. Safety and tolerability were e valuated clinically, biochemically and by the patient's diary. Only th e first cycle was evaluated. Results: 124 of the 144 intention-to-trea t 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 naus ea 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 (day s 1-6) occurred in the 5 mg than in the 2 mg group. Efficacy rates ran ged widely between chemotherapy regimens, independent of the tropisetr on 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.