Oncology
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The efficacy and tolerability of the new selective aromatase inhibitor, anastrozole (Arimidex), was compared with megestrol acetate in the treatment of advanced breast cancer in postmenopausal women. In two independent prospective randomised trials, patients who progressed after prior tamoxifen therapy received anastrozole 1 or 10 mg once daily, or megestrol acetate, 40 mg q.i.d. The two studies were designed to allow the data to be combined to increase the statistical power of the analyses. ⋯ All three treatments were generally well tolerated, but significantly more patients on megestrol acetate gained weight, and the weight gain in this group continued up to at least 9 months of follow-up. At a 12-month update of tolerability, of the commonly observed adverse events, a greater than 2-fold difference between treatment arms was observed for hypertension, weight gain, dyspnoea, vaginal haemorrhage, sweating and diarrhoea (all higher on megestrol acetate except for diarrhoea). Anastrozole is effective and well tolerated and on the basis of these data, 1 mg once daily is the recommended clinical dose in postmenopausal women with advanced breast cancer.
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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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Treatment results of advanced soft tissue sarcomas are still suboptimal. To evaluate the clinical effects of a combination therapy (FADIP) with Adriamycin (ADM), ifosfamide (IFO), cisplatin (DDP) plus continuous infusion of 5-fluorouracil (FU) as a synergistic factor for alkylating agents, a phase II study was initiated in patients with advanced soft tissue sarcomas of different histological subtypes. Fifty-six previously untreated patients with advanced soft tissue sarcomas of different histological subtypes (24 females, 31 males, median age 51.3 years, median Karnofsky performance status 80%) were included in this study. ⋯ FADIP produces comparable response rates to other standard treatment regimens in soft tissue sarcomas. Prolonged duration of response and median survival may be due to the use of continuous infusion of FU as a synergistic factor to alkylating agents. Granulocyte colony-stimulating factor is effective in reducing the otherwise observed high rate of WHO grade III/IV hematological toxicity with severe neutropenia.
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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.