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.

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.