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Weekly Paclitaxel and Gemcitabine in Advanced Transitional-Cell Carcinoma of the Urothelium: A Phase II Hoosier Oncology Group Study

From the Division of Hematology/Oncology and Biostatistics, Indiana University School of Medicine; the Hoosier Oncology Group and Walter Cancer Institute, Indianapolis; Michiana Hematology and Oncology, South Bend; and Oncology Hematology Associates of Southwest Indiana, Evansville, IN

Address reprint requests to Christopher J. Sweeney, MBBS, Indiana University, 535 Barnhill Dr, Rm 473, Indianapolis, IN 46202; e-mail: chsweene{at}iupui.edu

PURPOSE: To evaluate the efficacy and toxicity of weekly paclitaxel and gemcitabine in patients with advanced transitional-cell carcinoma (TCC) of the urothelial tract.

PATIENTS AND METHODS: Patients with advanced unresectable TCC were enrolled onto this multicenter, community-based, phase II trial. Initially, patients were treated with paclitaxel 110 mg/m² and gemcitabine 1,000 mg/m² by intravenous infusion on days 1, 8, and 15 every 28 days. Patients who had an objective response or stable disease continued treatment for a maximum of six courses. Paclitaxel was decreased to 90 mg/m² and gemcitabine was decreased to 800 mg/m² for the last 12 patients because of a concerning incidence of pulmonary toxicity in the first 24 patients.

RESULTS: Thirty-six patients were enrolled between September 1998 and March 2003. Twenty-four patients received the higher doses of paclitaxel and gemcitabine, and 12 patients received the lower doses. Twenty-five (69.4%) of 36 patients had major responses to treatment, including 15 patients (41.7%) with complete responses. With a median follow-up time of 38.7 months, the median survival time was 15.8 months. Grade 3 and 4 toxicities included granulocytopenia (36.1%), thrombocytopenia (8.3%), and neuropathy (16.7%). Five patients (13.9%) had grades 3 to 5 pulmonary toxicity, and one patient had grade 2 pulmonary toxicity.

CONCLUSION: Weekly paclitaxel and gemcitabine is an active regimen in the treatment of patients with advanced TCC. However, because of the high incidence of pulmonary toxicity associated with this schedule of paclitaxel and gemcitabine, we recommend against the use of this regimen in this patient population.

Supported by grant No. B9E-MC-X185 from Eli Lilly and Co, Indianapolis, IN.

Presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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