In the magnesium group, 30% of the subjects reached a normal PC(20) compared with 10% in the placebo group. We conclude that intravenous magnesium sulfate significantly improved bronchial hyperreactivity and may serve as an adjunct to standard treatment.
Summary The present phase 11 trial was undertaken to assess the efficacy and toxicity of a combination of paclitaxel and carboplatin as firstline chemotherapy in patients with metastatic transitional cell carcinoma of the urothelium. Twenty patients (age range 50-79 years; inclusion criteria: WHO performance status 0-2. no previous cytotoxic treatment) with metastatic transitional cell carcinoma of the urothelium were recruited and received cytotoxic treatment with paclitaxel at a dosage of 175 mg m-2 administered over a 3-h infusion and carboplatin given at an AUC of 5 mg ml-min (according to creatinine clearance) administered every 21 days. A total of 65% of patients achieved remissions (CR+PR), with CR occurring in 40% of patients. A further 15% of patients experienced stable disease. Remissions occurred after 2.4 ± 0.8 (mean ± standard deviation; range two to four) treatment cycles. The mean duration of responses (CR+PR) was 8.5 ± 5.5 months. After a mean observation period of 11.4 ± 4.8 months, 16 patients (80%) are alive. Toxicity included alopecia of WHO grade 3 in all patients, leucopenia of WHO grades 1 and 2 in ten patients, grade 3 in eight and grade 4 in two patients and, finally, severe thrombocytopenia grade 3 in only three patients. Non-haematological toxicity consisted of polyneuropathy of WHO grade 1 in 13 patients and grade 2 in five patients. We thus conclude that a combination of paclitaxel and carboplatin at the given dosage and schedule constitutes an active, well-tolerated first-line cytotoxic treatment for patients with metastatic urothelial cancer.
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