Journal of Clinical Oncology, Vol 15, 124-130, Copyright © 1997 by American Society of Clinical Oncology
Ondansetron versus metoclopramide, both combined with dexamethasone, in the prevention of cisplatin-induced delayed emesis. The Italian Group for Antiemetic Research
PURPOSE: The role of 5-HT3 receptor antagonists in the prevention of
chemotherapy-induced delayed emesis is controversial. We compared
ondansetron and metoclopramide, both combined with dexamethasone, in
cisplatin-treated patients. PATIENTS AND METHODS: Three hundred twenty- two
patients who had been given > or = 50 mg/m2 of cisplatin were randomly
assigned to receive, from days 2 to 4 after chemotherapy, oral ondansetron
(8 mg twice daily) or oral metoclopramide (20 mg every 6 hours), both
associated with intramuscular dexamethasone (8 mg twice on days 2 and 3,
and 4 mg twice on day 4). Patients received the same intravenous
prophylaxis for acute emesis: ondansetron 8 mg and dexamethasone 20 mg.
Nausea and vomiting were assessed daily until day 6 after chemotherapy.
RESULTS: According to the intention-to-treat principle, 318 patients were
assessable. Known prognostic factors were similar in the two treatment
groups. Complete protection from delayed vomiting and nausea was achieved
by 62.0% and 43.7% of patients treated with ondansetron and by 60.0% and
53.7% of those receiving metoclopramide (no significant differences).
Patients who vomited in the first 24 hours achieved the lowest complete
protection from delayed emesis. In these patients, ondansetron offered
better complete protection from vomiting than metoclopramide (28.6% v 3.8%,
P < .05). Both treatments were well tolerated. CONCLUSION: The two
treatments offer similar protection from delayed emesis, although
ondansetron plus dexamethasone may be preferred in patients who suffer from
acute vomiting. Optimal control of acute emesis is essential to achieve
good protection from delayed nausea and vomiting, irrespective of the
antiemetic treatment received.
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