Oncology
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Randomized Controlled Trial Clinical Trial
Does dexamethasone enhance the efficacy of alizapride in cis-platinum-induced delayed vomiting and nausea?
At the present time 5-HT3 antagonists in combination with corticosteroids represent the best prophylaxis and treatment of acute vomiting and nausea in highly emetogenic cancer chemotherapy. However, 24 h after chemotherapy 5-HT3 antagonists are no longer superior to benzamides for prevention of delayed symptoms. All recommendations for use of corticosteroids in delayed nausea and vomiting basically rely on one small study by Kris et al. [J Clin Oncol 1989;7:108-114]. ⋯ In contrast to acute nausea and vomiting the addition of corticosteroids is not beneficial in the prevention of delayed nausea and vomiting. Until better strategies are available the best prophylaxis of delayed symptoms is the control of acute nausea and vomiting using 5-HT3 antagonists plus corticosteroids. The use of benzamides has to be considered efficacious in the prevention of delayed vomiting and nausea.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
A randomised, double-blind, parallel-group study to compare the efficacy and safety of ondansetron (GR38032F) plus dexamethasone with metoclopramide plus dexamethasone in the prophylaxis of nausea and emesis induced by carboplatin chemotherapy.
A double-blind, parallel-group study in 189 ovarian cancer patients compared the efficacy of ondansetron 8 mg i.v. (OND) and metoclopramide 60 mg i.v. (MET) both in combination with dexamethasone 20 mg i.v. in the prevention of carboplatin-induced emesis. On day 1, complete or major control of emesis (0-2 emetic episodes) was observed in 97% patients from the OND group compared with 74% patients from the MET group (p < 0.001). Similarly, a worst-day analysis over days 1-3 showed complete or major control of emesis in 87% patients (OND) compared wth 66% patients (MET) (p < 0.001). ⋯ Fewer patients from the OND group (13%) reported adverse events compared with the MET group (21%). Extrapyramidal type symptoms were observed in 6 (6%) patients from the MET group (paraesthesia, involuntary movement of the jaw and tongue, and restlessness), compared with none from the OND group. Ondansetron plus dexamethasone is a highly effective and well-tolerated treatment and is significantly superior to metoclopramide plus dexamethasone in the prevention of carboplatin-induced emesis.
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Randomized Controlled Trial Comparative Study Clinical Trial
Comparison of two different doses of ondansetron plus dexamethasone in the prophylaxis of cisplatin-induced emesis.
This study was conducted to evaluate the efficacy of two different doses of ondansetron (8 mg vs. 24 mg) plus dexamethasone in the prevention of cisplatin (CDDP)-induced emesis and nausea (acute and delayed). The persistence of the anti-emetic efficacy during the second cycle of chemotherapy was also assessed. Eighty patients receiving high-dose CDDP (>80 mg/m2) were randomized to have either ondansetron 8 mg plus dexamethasone 20 mg (8 mg group) or ondansetron 24 mg plus dexamethasone 20 mg (24 mg group), given intravenously as a single dose before the CDDP infusion. ⋯ The figures for the delayed nausea were: 12 (48%) and 13 (50%), 2 (15.4%) and 2 (18.2%), respectively. Similar protection against emesis and nausea was recorded during the second cycle of chemotherapy. Both regimens have the same efficacy and thus, taking into account the cost-effectiveness, 8 mg of ondansetron plus dexamethasone in a single intravenous dose should be used for the prevention of high-dose CDDP-induced emesis.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
5-HT3 receptor antagonists in the control of cisplatin-induced delayed emesis.
Two large randomized, double-blind, placebo-controlled studies with an appropriate study design have been conducted to fully evaluate the efficacy of ondansetron in the control of cisplatin-induced delayed emesis. These studies show that ondansetron and particularly ondansetron plus dexamethasone have moderate efficacy in the control of cisplatin-induced delayed emesis and nausea. The benefit of ondansetron, with or without dexamethasone, may be greatest in patients with incomplete control of acute emesis. The efficacy of ondansetron in this setting compared to its greater efficacy during the acute phase of emesis induced by cisplatin and the more prolonged phases of acute emesis induced by cyclophosphamide and carboplatin indicates that non-5-HT3-mediated emetic mechanisms maybe are relatively more important in the delayed phase of emesis following cisplatin.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Ondansetron compared with granisetron in the prophylaxis of cyclophosphamide-induced emesis in out-patients: a multicentre, double-blind, double-dummy, randomised, parallel-group study. Emesis Study Group for Ondansetron and Granisetron in Breast Cancer Patients.
This is the first double-blind clinical trial in a homogenous group of patients to compare the recommended dosing schedules of ondansetron and granisetron in the control of prolonged emesis after cyclophosphamide-containing chemotherapy (48% CMF, 35% EC) for breast cancer. A total of 514 patients were recruited. Of the 488 patients included in the intent-to-treat analyses, 167 were randomised to group A [8 mg ondansetron intravenously (i.v.) + placebo by mouth (p.o.) before chemotherapy + 8 mg ondansetron p.o. twice daily (b.d.) until day 5], 155 to group B (placebo i,.v. + 8 mg ondansetron p.o. before chemotherapy + 8 mg ondansetron p.o. b.d. until day 5) and 166 to group C (3 mg granisetron i.v. + placebo p.o. before chemotherapy + placebo p.o. b.d. until day 5). ⋯ Logistic regression analyses adjusted for prognostic factors also revealed a significant difference (p = 0.011) in favour of the i.v. + ondansetron group compared with the granisetron group when complete plus major response was compared over days 2-5. No significant differences in the safety profiles of the three treatment groups were observed. There were no severe or unexpected drug-related adverse events and as is well established for the serotonin receptor antagonists, mild constipation (mean 8%) and mild headache (mean 8%) were most commonly reported.