COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL

Comparison of the efficacy and safety of oral granisetron plus dexamethasone with intravenous ondansetron plus dexamethasone to control nausea and vomiting induced by moderate/severe emetogenic chemotherapy

T J Chiou, W F Tzeng, W S Wang, C C Yen, F S Fan, J H Liu, P M Chen
Zhonghua Yi Xue za Zhi, Chinese Medical Journal; Free China Ed 2000, 63 (10): 729-36
11076429

BACKGROUND: Chemotherapy-induced nausea and vomiting can affect cancer patients' compliance with cytotoxic chemotherapy. Currently, there are some new antiemetic therapies for the treatment of chemotherapy-induced emesis. A single institution, randomized, open, parallel trial was done to compare oral granisetron plus intravenous (i.v.) dexamethasone with intravenous ondansetron for the prevention of moderate or severe emetogenic chemotherapy-induced acute and delayed emesis.

METHODS: Fifty-one cancer patients were treated with moderate/severe emetogenic chemotherapy and randomized to receive either oral granisetron 1 mg twice daily or i.v. ondansetron 8 mg every 8 hours combined with i.v. dexamethasone 10 mg on the day of chemotherapy. The efficacy and safety of the two antiemetic regimens were compared.

RESULTS: Oral granisetron plus i.v. dexamethasone had comparable antiemetic efficacy for the prevention of nausea in the first 24-hour period after initiation of chemotherapy compared with intravenous ondansetron plus i.v. dexamethasone. The complete response of antiemesis in the first 24-hour period after initiation of antiemetic therapy between granisetron and ondansetron were 84.0% (95% CI, 62.9%-95.6%) and 84.6 (95% CI, 64.0%-97.5%). The complete response for delayed emesis after initiation of antiemetic therapy between granisetron and ondansetron were 16.0% (95% CI, 4.5%-36.1%) and 19.2% (95% CI, 6.8%-40.7%0. There was diarrhea in 12% of patients receiving granisetron therapy and constipation in 23.1% of the ondansetron group.

CONCLUSIONS: Oral granisetron plus i.v. dexamethasone and i.v. ondansetron plus i.v. dexamethasone are potentially equally effective antiemetic agents in the prevention of moderate or severe emetogenic chemotherapy-induced acute or delayed emesis. Oral granisetron with dexamethasone appears to be a suitable alternative antiemetic agent in cancer patients who receive moderately or severely emetogenic chemotherapy.

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