Study of efficacy and tolerability of tropisetron in the prevention of cisplatin induced nausea and vomiting.

The efficacy and tolerability of tropisetron alone or in combination with dexamethasone was studied in an open randomised trial in a total of 30 patients undergoing cisplatin based chemotherapy. Patients received tropisetron 5 mg plus dexamethasone 8 mg i.v. on day 1 followed by tropisetron 5 mg p.o. plus dexamethasone 4 mg orally bid on day 2-6 (group I) versus tropisetron 5 mg p.o. alone on day 2-6 (group II). No demographic difference among the groups was observed. Tumor locations were mainly at cervix (23%) and ovary (17%). Acute emesis was prevented completely, defined as no nausea and no vomiting, in 75 per cent of patients in group 1 compared with 73 per cent in group II. Delayed emesis was completely prevented in significantly more patients in group I (81% versus 49%). Adverse events were mild and similar in both groups. The most frequent side effects were headache, stupor and diarrhea. In conclusion, tropisetron is an effective and well tolerated antiemetic for preventing acute and delayed emesis in cisplatin-based chemotherapy. In addition, combining dexamethasone improved the efficacy in particular in controlling delayed emesis.