A Randomized Trial to Compare the Efficacy and Safety of Antiemetic Treatment with Ondansetron and Ondansetron Zydis in Patients with Breast Cancer Treated with High-dose Epirubicin

Abstract

Objective: The objective of this study was to compare the efficacy of a disintegrating tablet of ondansetron (ODT) and the conventional tablet formulation of ondansetron (OT) in controlling nausea and vomiting in breast cancer patients. Patients and Methods: A total of 134 breast cancer patients receiving high-dose epirubicin participated in a randomized trial comparing the antiemetic efficacy and safety of an 8 mg OT given twice daily to an 8 mg orally ODT given twice daily, both for 3 days. Results: OT was significantly better in the complete control of emesis (72% versus 52%, p=0.020) and marginally better in the complete control of nausea (66% versus 48%, p=0.054) induced by high-dose epirubicin over days 1-3 compared to ODT. However, no differences were found in major control of emesis (0 to 2 emetic episodes, 76% versus 70%, p=0.28) over days 1-3. Conclusion: OT was significantly better in the complete control of emesis and marginally better in the complete control of nausea, but not in the major control of emesis and nausea induced by high-dose epirubicin compared to ODT. ODT may be an effective alternative to OT, particularly in patients who have difficulties in swallowing a conventional tablet.