A Randomized Open-Label Parallel-Group Study Comparing Ondansetron with Ondansetron plus Dexamethasone in Patients with Metastatic Breast Cancer Receiving High-Dose Epirubicin. A Hellenic Cooperative Oncology Group Study
| العنوان: | A Randomized Open-Label Parallel-Group Study Comparing Ondansetron with Ondansetron plus Dexamethasone in Patients with Metastatic Breast Cancer Receiving High-Dose Epirubicin. A Hellenic Cooperative Oncology Group Study |
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| المؤلفون: | Dimitrios Bafaloukos, Jim Janinis, George Fountzilas, Dimosthenis Skarlos, Athanasios Athanasiades, Kostas Nikolaides, Paris Kosmidis, Theodore Giannakakis, Nicholas Pavlidis |
| المصدر: | Tumori Journal. 86:37-41 |
| بيانات النشر: | SAGE Publications, 2000. |
| سنة النشر: | 2000 |
| مصطلحات موضوعية: | Cancer Research, Antiemetics/*therapeutic use, Vomiting, Nausea, medicine.medical_treatment, Breast Neoplasms, Serotonin Antagonists/*therapeutic use, Dexamethasone, 030218 nuclear medicine & medical imaging, Ondansetron, 03 medical and health sciences, Ondansetron/administration & dosage/*therapeutic use, 0302 clinical medicine, Vomiting/*prevention & control, medicine, Humans, Retching, Adverse effect, Epirubicin, Dexamethasone/*administration & dosage, Chemotherapy, Antibiotics, Antineoplastic, business.industry, Breast Neoplasms/*drug therapy, Epirubicin/*adverse effects, General Medicine, Middle Aged, Oncology, 030220 oncology & carcinogenesis, Anesthesia, Antiemetics, Drug Therapy, Combination, Female, Serotonin Antagonists, medicine.symptom, Antibiotics, Antineoplastic/*adverse effects, business, medicine.drug |
| الوصف: | Aims and background The purpose of this multicenter randomized, open-label, parallel-group study was to assess whether the addition of low-dose dexamethasone to ondansetron results in improved control of chemotherapy-induced emesis in patients undergoing first-line chemotherapy with high-dose epirubicin. Methods & study design Patients were randomized to receive either 24 mg of ondansetron or 24 mg of ondansetron plus 8 mg of dexamethasone administered as an intravenous infusion 30 minutes prior to administration of chemotherapy. Both groups of patients received 8 mg of ondansetron given orally from day 2 to 5 two times daily. Fifty-three patients received ondansetron and 50 received ondansetron plus dexamethasone. The patients recorded nausea and the number of vomits and retches daily on diary cards. Results Significantly more patients in the ondansetron plus dexamethasone group experienced neither vomiting nor retching during the first day of the first course of chemotherapy compared to those receiving ondansetron alone (79.6% vs 53.8%, P = 0.0062). Furthermore, there was a trend in favor of ondansetron plus dexamethasone in the control of nausea. There was no statistically significant difference between ondansetron plus dexamethasone versus ondansetron alone in protecting patients from emesis between days 2 and 5 of the first course of chemotherapy (66.7% vs 62.7%, P = 0.68). This was probably due to the small sample size. Ondansetron was well tolerated, with 15 patients (15%) reporting adverse events such as headache or constipation. Conclusions It appears that ondansetron given intravenously in combination with dexamethasone is more effective than ondansetron alone in the control of acute emesis in patients undergoing their first course of chemotherapy with high-dose epirubicin. No difference between the regimens was found with regard to nausea and delayed emesis control. |
| تدمد: | 2038-2529 0300-8916 |
| DOI: | 10.1177/030089160008600107 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4629ca4a089ffd615c20e82c5401a483 https://doi.org/10.1177/030089160008600107 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....4629ca4a089ffd615c20e82c5401a483 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 20382529 03008916 |
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| DOI: | 10.1177/030089160008600107 |