TROPISETRON IN THE PREVENTION OF NAUSEA AND VOMITING IN 131 CHILDREN RECEIVING CYTOTOXIC CHEMOTHERAPY

Tropisetron (Navoban(R), Sandoz Pharma Ltd., Basel, Switzerland), a se lective antagonist of the serotonin receptor (5-HT3) dosed once-daily at 0.2 mg/kg (with a maximum of 5 mg daily), was evaluated in the prev ention of chemotherapy-induced nausea and vomiting in 131 children wit h a median age of 5 years (age 10 weeks to 21 years). Acute lymphocyti c leukemia was the most common malignancy (49%). Most children (82%) h ad received cytotoxic chemotherapy before enrollment. Patients receive d tropisetron during one or more courses of chemotherapy (455 courses in total). Tropisetron was administered slowly intravenously as a sing le dose before the start of chemotherapy on day 1 and intravenously or by mouth the subsequent days as a single daily dose (median treatment duration: 5 days). Response to tropisetron per 24 hour period on the first 5 days of each chemotherapy course was graded as complete (absen ce of both nausea and vomiting), partial (one to four vomits and/or le ss than 5 hours of nausea), or failure. Overall complete response on d ay 1 was observed in 305 out of 455 chemotherapy courses (67%). The pa tients receiving intravenous chemotherapy (N = 92) had a 70% complete response rate and a 26% partial response rate on day 1, both for cours e 1 and course 2. The percentage of complete responders increased the subsequent days of the course. Emesis after day 1 was observed primari ly during courses with the most emetogenic chemotherapy. No side-effec ts of tropisetron other than a single case of diarrhoea were documente d in this study. (C) 1995 Wiley-Liss, Inc.