Seminars in oncology
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Seminars in oncology · Dec 1992
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialSingle-dose ondansetron for the prevention of cisplatin-induced emesis: efficacy results.
Ondansetron 0.15 mg/kg, given intravenously (IV) every 4 hours for three doses, has replaced metoclopramide as standard antiemetic therapy for patients receiving cisplatin-based chemotherapy. Several clinical observations suggested that ondansetron may be effective when given in a single dose: (1) demonstration of efficacy over a wide dose range, (2) similar efficacy with dosing intervals of 2, 4, 6, and 8 hours, and (3) efficacy of single-dose regimens with high-dose metoclopramide and other 5-hydroxytryptamine3 antagonists. In this study, patients receiving cisplatin-based chemotherapy were randomized to receive one of three ondansetron dosing regimens: ondansetron 0.15 mg/kg IV every 4 hours x 3 (standard schedule), ondansetron 32 mg IV x 1, or ondansetron 8 mg IV x 1. ⋯ All three schedules were well tolerated. Ondansetron 32 mg given prior to cisplatin is superior to a single 8-mg dose and is at least as effective, if not superior to, the standard three-dose schedule (0.15 mg/kg every 4 hours). On the basis of these data, ondansetron 32 mg should be considered standard therapy in patients receiving cisplatin-based chemotherapy and should be the schedule with which new antiemetics and alternate dosing schedules are compared.
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Seminars in oncology · Dec 1992
Results of a compassionate-use program using intravenous ondansetron to prevent nausea and vomiting in patients receiving emetogenic cancer chemotherapy.
This study reports the effectiveness and side effects of intravenous ondansetron as a single-agent antiemetic therapy for patients receiving emetogenic cancer chemotherapy under a compassionate-use program for patients not enrolled in controlled clinical trials. Patients were > or = 7 years old and had uncontrolled nausea and vomiting or intolerable side effects with standard antiemetics administered with previous cancer chemotherapy. All patients received ondansetron 0.15 mg/kg every 4 hours x 3 daily doses beginning 30 minutes prior to emetogenic chemotherapy. ⋯ Forty-four patients (23%) experienced other adverse effects (headache, 17 patients; diarrhea, eight patients; all other events occurred in two or fewer patients). Only six patients were withdrawn due to adverse effects. In conclusion, ondansetron therapy resulted in significantly improved control of nausea and vomiting, fewer side effects, and better quality of life than standard antiemetic therapy in the same patients receiving similar chemotherapy regimens.