SIGNIFICANT ACTIVITY OF PACLITAXEL IN ADVANCED TRANSITIONAL-CELL CARCINOMA OF THE UROTHELIUM - A PHASE-II TRIAL OF THE EASTERN-COOPERATIVE-ONCOLOGY-GROUP

Purpose: To assess the efficacy and toxicity of single-agent paclitaxe l as first-line chemotherapy in patients with locally advanced or mel astatic transitional-cell carcinoma of the urothelium. Patients end Me thods: Twenty-six eligible patients were enrolled onto this cooperativ e group study and treated with paclitaxel at a dosage of 250 mg/m(2) b y 24-hour continuous infusion every 21 days until progression or patie nt intolerance. All patients received recombinant human granulocyte co lony-stimulating factor (rhG-CSF) at 5 mu g/kg/d for at least 10 days during each cycle. Results: Eleven of 26 patients (42%; 95% confidence interval [CI], 23% to 63%) demonstrated an objective response, with s even achieving a complete clinical response (CR) (27%; 95% CI, 12% to 48%) and four (15%) a partial response (PR). The median duration of re sponse in the 11 responders is 7+ months (range, 4 to 17), with five r esponders (four CRs, one PR) remaining progression-free at 5, 6, 10, 1 2, and 16 months from the start of therapy. The estimated median survi val duration for all patients is 8.4 months. Hematologic toxicity cons isted of anemia (12% grade 3) and granulocytopenia (4% grade 3, 19% gr ade 4), with two patients developing granulocytopenic fevers. Nonhemat ologic toxicity included grade 3 mucositis in 11%, grade 3 neuropathy in 11%, and grade 4 diarrhea in 4%. Conclusion: Single-agent paclitaxe l at this dosage and schedule is one of the most active single agents in previously untreated patients with advanced urothelial carcinoma, a nd is well tolerated by this patient population when given with hemato poetic growth factor support. (C) 1994 by American Society of Clinical Oncology.