Preliminary experience with paclitaxel in advanced bladder cancer.

In a phase II Eastern Cooperative Oncology Group trial, single-agent paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) was administered to 26 patients with advanced urothelial cancer who had not received prior systemic chemotherapy. Paclitaxel was given at a dose of 250 mg/m2 by 24-hour continuous infusion along with prophylactic granulocyte colony-stimulating factor. Despite a 23% incidence of grade 3 or 4 neutropenia, only two patients developed febrile neutropenia; other hematologic toxicity was mild and not dose limiting. Nonhematologic toxicity included grade 3 neurologic toxicity in three patients, grade 3 mucositis in three patients, and grade 4 diarrhea in one patient. Eleven of 26 (42%) patients had an objective response (seven clinical complete responses, four partial responses), two had stable disease as their best response, and 13 patients progressed while on therapy. Preliminary response data suggest significant single-agent activity for paclitaxel in transitional cell carcinoma of the bladder. Future studies will evaluate paclitaxel-containing combination regimens as first-line therapy for advanced disease and define the role of paclitaxel in salvage therapy following conventional chemotherapy.