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

A single centre double-blind randomised study was performed to determi ne 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 gro ups, and received either navoban (n = 58) or a standard antiemetic tre atment of dexamethasone plus metoclopramide (n = 57). Within the first 24 hours after receiving cisplatin-based chemotherapy, 76% of patient s 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). Improv ed control of emesis was also observed over 4 consecutive days of foll ow-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 cispl atin in a dosage of > 100 mg/m2 was comparable with patients receiving cisplatin < 100 mg/m2. A significantly lower intensity of adverse eve nts 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 conse cutive chemotherapy cycle. The incidence of adverse events did not inc rease with repeated cycles of treatment, nor were they consistently re peated by the same patients in additional cycles. Thus, navoban appear s to be an effective and well-tolerated antiemetic agent for use in pa tients receiving cisplatin-based chemotherapy.