Paclitaxel and gemcitabine chemotherapy for advanced transitional-cell carcinoma of the urothelial tract: A phase II trial of the Minnie Pearl CancerResearch Network

Purpose: To evaluate the toxicity and efficacy of combination chemotherapy with paclitaxel and gemcitabine in patients with advanced transitional-cell carcinoma of the urothelial tract. Patients and Methods: Fifty-four patients with advanced unresectable urothe lial carcinoma entered this multi-centered, community-based, phase II trial between May 1997 and December 1999. All patients were treated with paclita xel 200 mg/m(2) by 1-hour intravenous (IV) infusion on day 1 and gemcitabin e 1,000 mg/m(2) IV an days 1, 8, and 15; courses were repeated every 21 day s. Patients who had objective response or stable disease continued treatmen t for six courses. Results: Twenty-nine of 54 patients (54%; 95% confidence interval, 40% to 6 7%) had major responses to treatment, including 7% complete responses. With a median follow-up of 24 months, 16 patients (30%) remain alive and nine ( 17%) are progression-free, The median survival for the entire group was 14. 4 months; 1- and 2-year actuarial survival rates were 57% and 25%, respecti vely. Seven (47%) of 15 patients previously treated with platinum-based che motherapy responded to paclitaxel/gemcitabine. Grade 3/4 toxicity was prima rily hematologic, including leukopenia (46%), thrombocytopenia (13%), and a nemia (28%). Ten patients (19%) required hospitalization for neutropenia an d fever, and one patient had treatment-related septic death. Conclusion: The combination of paclitaxel and gemcitabine is active and wel l tolerated in the first- or second-line treatment of patients with advance d transitional-cell carcinoma of the urothelial tract. Response rate and du ration compare favorably with those produced by other active, first-line re gimens. This regimen should be further evaluated in phase II and III studie s, as well as in patients with compromised renal function. J Clin Oncol 19: 3018-3014, (C) 2001 by American Society of Clinical Oncology.