PACLITAXEL AND CARBOPLATIN IN PATIENTS WITH METASTATIC UROTHELIAL CANCER - RESULTS OF A PHASE-II TRIAL

The present phase II trial was undertaken to assess the efficacy and t oxicity of a combination of paclitaxel and carboplatin as first-line c hemotherapy in patients with metastatic transitional cell carcinoma of the urothelium. Twenty patients (age range 50-79 years; inclusion cri teria: WHO performance status 0-2, no previous cytotoxic treatment) wi th metastatic transitional cell carcinoma of the urothelium were recru ited and received cytotoxic treatment with paclitaxel at a dosage of 1 75 mg m(-2) administered over a 3-h infusion and carboplatin given at an AUC of 5 mg ml(-1) min (according to creatinine clearance) administ ered 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 (mea n +/- standard deviation; range two to four) treatment cycles. The mea n duration of responses (CR+PR) was 8.5 +/- 5.5 months. After a mean o bservation 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 i n two patients and, finally, severe thrombocytopenia grade 3 in only t hree patients. Non-haematological toxicity consisted of polyneuropathy of WHO grade 1 in 13 patients and grade 2 in five patients. We thus c onclude that a combination of paclitaxel and carboplatin at the given dosage and schedule constitutes an active, well-tolerated first-line c ytotoxic treatment for patients with metastatic urothelial cancer.