Ondansetron(GR38032F) is a novel agent that selectively binds to the 5-hydroxytryptamine 3 receptor, and is reported to have prominent effect in the prevention of antineoplastic agent induced nausea and vomiting. We gave ondansetron to 30 advanced cancer patients who were receiving cisplatin containing combination chemotherapy. This study was open phase II trial de-signed to evaluate the safety and efficacy of ondansetron in preventing nausea and vomiting induced by cisplatin containing regimen, and related side effects. Of the 30 patients, male to female ratio was 23: 7, and median age was 53(35-75).
Primary neoplasms were as following, esophagus 7, head and neck 5, lung 4, stomach 3, ovary 2, skin 2, unknown primary 2, thymus 1, biliary tract 1, uterine cervix 1, liver 1, and renal pelvis 1. 5-FU and/or doxorubicin, and/or cyclophosphamide, and/or etoposide, and/or mitomycin-c were combined with cispltin (60- 100 mg/M²).
Ondansetron 8 mg was given as 15 minutes intravenous infusion 30 minutes prior to cisplatin infusion and administered 24 hours as continuous infusion at a rate of 1 mg/hr, and during day 2-6, the patients were received oral ondansetron at a dose of 8 mg tid. On day 1, nausea was controlled in 60.0% of patients(none: 33.3%, mild 26.7%) and emesis(vomiting and retching) was controlled in 63.3%(complete 40.0%, major 23.3%). On day 2-6, nausea was controlled in 46.7% of patients(none 16.7%, mild 30.0%). Ondansetron related side effects were mild with headache 23. 3%, dizziness 13.3%, abdominal pain 10.0%, general weakness 6.7% and dyspnea 3.3%. The results showed that ondansetron is effective in control of cisplatin induced nausea and emesis, and can be administered safely with minimal side effects, but prolonged intravenous administration of ondansetron is recommended in patients with delayed emesis.
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