Journal of Clinical Oncology, Vol 8, 731-735, Copyright © 1990 by American Society of Clinical Oncology
Ondansetron: a new antiemetic for patients receiving cisplatin chemotherapy
LH Einhorn, C Nagy, K Werner and AL Finn
Department of Medicine, Indiana University Medical Center, Indianapolis.
GR 38032F (ondansetron) is a selective serotonin subtype-3 receptor
antagonist with reported antiemetic efficacy in patients receiving
cisplatin. This study evaluated the safety and efficacy of ondansetron in
three consecutive nonrandomized groups of patients who were receiving a 4-
or 5-day regimen of cisplatin (20 to 40 mg/m2/d) combination chemotherapy.
Thirty-six patients were enrolled. Thirty- five patients were assessable
for efficacy. All patients received three daily intravenous doses of 0.15
mg/kg of ondansetron. Twenty-four patients had received no prior
chemotherapy. Twelve of these received ondansetron every 2 hours and 12
received ondansetron every 6 hours. Twelve additional patients who had
received at least one prior course of chemotherapy were administered
ondansetron every 6 hours. All patients were monitored for emetic episodes
(vomiting or retching), adverse events, and laboratory safety parameters.
Ten patients (29%) had no vomiting or retching throughout the entire study
period and 18 patients (51%) experienced two or fewer emetic episodes
during the entire study period. The greatest antiemetic efficacy was on day
1 when 27 patients (77%) had no emesis. The chemotherapy-naive patients
responded better than the nonnaive patients on all study days. Reported
adverse events were minor, with the most common possibly drug-related event
being headache (14% of patients). No extrapyramidal symptoms were observed.
Transient increases in total SGOT, and SGPT were observed in some patients.
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