A Comparative Study of the Use of Navoban (ICS 205-930), a 5-HT₃ Antagonist, versus a Standard Antiemetic Regimen of Dexamethasone and Metoclopramide in the Treatment of Cisplatin-Containing Chemotherapy

Summary

A single centre double-blind randomised study was performed to determine the comparative efficacy and tolerability of a new antiemetic agent, navoban (ICS 205-930). 115 patients with malignant disease, who had not previously received chemotherapy, were randomly allocated to 2 groups, and received either navoban (n = 58) or a standard antiemetic treatment of dexamethasone plus metoclopramide (n = 57). Within the first 24 hours after receiving cisplatin-based chemotherapy, 76% of patients in the navoban group remained free of vomiting (with 59% of patients free of nausea) compared with 39% of patients free of vomiting in the conventionally treated group (30% of patients free of nausea). Improved control of emesis was also observed over 4 consecutive days of follow-up in the navoban group. The difference in incidence of nausea and vomiting between the patient groups was statistically significant (p < 0.05). The antiemetic activity of navoban in patients receiving cisplatin in a dosage of > 100 mg/m² was comparable with patients receiving cisplatin < 100 mg/m². A significantly lower intensity of adverse events was seen in the navoban group. Headache and constipation were more common with navoban, while extrapyramidal symptoms and somnolence as well as hypotonia were more frequent in the standard treatment group. The efficacy and tolerability of navoban was maintained over the consecutive chemotherapy cycle. The incidence of adverse events did not increase with repeated cycles of treatment, nor were they consistently repeated by the same patients in additional cycles. Thus, navoban appears to be an effective and well-tolerated antiemetic agent for use in patients receiving cisplatin-based chemotherapy.