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• W2149668026 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. Moderately emetogenic regimens, such as anthracycline- based chemotherapy regimens, are effective in the treatment of various malignancies, including breast cancer, and are usually administered on an outpatient basis. These regimens cause emesis in approximately 70% to 80% of patients, even when doxorubicin is administered as a slow continuous infusion and accompanied by conventional antiemetic therapy (1). Prevention of nausea and vomiting in patients receiving these regimens is very important since nausea and vomiting are the most distressing side-effects of chemotherapy occurring in patients not receiving antiemetic treatment (2). In addition nausea and vomiting may limit a patient's tolerance to and compliance with the treatment. Several studies have shown the efficacy of 5-HT3 during the acute phase of emesis. Ondansetron is a highly effective and well-tolerated anti-vomiting agent in patients receiving chemotherapy and radiotherapy. Both the i.v. and oral formulations have been extensively used for the prevention of nausea and vomiting associated with cisplatin or non- cisplatin chemotherapy (3, 4). In order to control nausea and vomiting in an outpatient basis, anti-vomiting regimens should be effective, well-tolerated, simple and convenient. Oral administration of an antiemetic may be the route of choice in an outpatient basis. Oral treatment with ondansetron has been shown to control nausea and vomiting induced by moderately emetogenic chemotherapy regimens (3-6). Ondansetron has also been shown to be superior to placebo, metoclopramide, alizapride and other conventional antiemetic regimens (3, 5-7). The conventional tablet" @default.
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• W2149668026 date "2007-11-01" @default.
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• W2149668026 title "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" @default.
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