Phase III double-blind comparison of intravenous ondansetron and metoclopramide as antiemetic therapy for patients receiving multiple-day cisplatin-based chemotherapy
✍ Scribed by George W. Sledge Jr.; Lawrence Einhorn; Catherine Nag; Karen House
- Publisher
- John Wiley and Sons
- Year
- 1992
- Tongue
- English
- Weight
- 508 KB
- Volume
- 70
- Category
- Article
- ISSN
- 0008-543X
No coin nor oath required. For personal study only.
✦ Synopsis
Background. Ondansetron hydrochloride is a selective serotonin subtype 3 (5HTJ receptor antagonist that has been shown to be an effective antiemetic in patients receiving cisplatin chemotherapy.
Methods. This double-blind study compared the safety and efficacy of intravenous ondansetron with metoclopramide in patients receiving a 4-or 5-day regimen of cisplatin (20-40 mg/m2/day) combination chemotherapy. Forty-five patients were enrolled, and efficacy of the drug therapy could be studied for all 45. Patients were randomly assigned (1:1) to receive three daily intravenous doses of either 0.15 mg/kg ondansetron or 1 mg/kg metoclopramide. All patients were monitored daily for the number of emetic episodes (vomiting or retching), severity of nausea, adverse events, and laboratory safety parameters.
Results. Seven (30%) patients who received ondansetron had no emetic episodes throughout the entire study period compared with two (9%) who received metoclopramide (P = 0.077). The greatest difference in antiemetic efficacy was seen on day 1, when 18 (78%) patients who received ondansetron had no emetic episodes compared with 3 (14%) patients who received metoclopramide (P < 0.001). Significantly fewer antiemetic treatment failures (more than five emetic episodes or withdrawal from the study) occurred with patients given ondansetron (9%) than with those given metoclopramide (50%) during the entire study period ( P = 0.002). The most commonly reported adverse event associated with on-From the