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Phase II Study of Pemetrexed for Second-Line Treatment of Transitional Cell Cancer of the Urothelium

Christopher J. Sweeney, Bruce J. Roth, Fairooz F. Kabbinavar, David J. Vaughn, Michael Arning, Rafael E. Curiel, Coleman K. Obasaju, Yanping Wang, Steven J. Nicol, Donald S. Kaufman

From the From Hoosier Oncology Group, Indianapolis, IN; Vanderbilt University Medical Center, Nashville, TN; University of California Los Angeles Medical Center, Los Angeles, CA; University of Pennsylvania, Philadelphia, PA; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN; and the Massachusetts General Hospital, Boston, MA

Address reprint requests to Donald S. Kaufman, MD, Massachusetts General Hospital, 55 Fruit St, Boston, MA 02114; e-mail: dskaufman{at}partners.org

PURPOSE: To assess the antitumor activity and toxicity of pemetrexed as second-line chemotherapy in patients with locally advanced or metastatic transitional cell carcinoma (TCC) of the urothelium.

PATIENTS AND METHODS: Eligible patients had a performance status of 0 or 1, adequate organ function, previous treatment with one prior chemotherapy regimen for locally advanced or metastatic TCC of the urothelium or relapsed within 1 year of adjuvant or neoadjuvant treatment. Patients received pemetrexed 500 mg/m² intravenously on day 1 every 21 days, with vitamin B₁₂, folic acid, and dexamethasone prophylaxis.

RESULTS: Forty-seven patients were enrolled and included in the intent-to-treat efficacy analysis. Responses: 3 (6.4%) complete responses and 10 (21.3%) partial responses produced an overall response rate of 27.7%. Ten patients (21.3%) had stable disease and 22 patients (46.8%) progressed. The median time to progressive disease was 2.9 months (95% CI, 1.7 months to 4.6 months) and median overall survival was 9.6 months (95% CI, 5.1 months to 14.6 months). Median duration of response was 5.0 months (95% CI, 3.9 months to 13.8 months). Of the 47 patients assessable for safety, grade 3 or 4 hematologic events were thrombocytopenia (8.5%; 0.0%), neutropenia (4.3%; 4.3%) and anemia (2.1%; 2.1%), respectively. Nonlaboratory toxicities included grade 4 stomatitis/pharyngitis, sepsis syndrome (one patient each), and grade 3 fatigue (three patients) and diarrhea (two patients).

CONCLUSION: Single-agent pemetrexed is safe and active as second-line treatment of patients with advanced TCC of the urothelium. Additional evaluation in the first- or second-line setting in TCC of the urothelium is warranted.

Supported by a grant from Eli Lilly Oncology, Indianapolis, IN.

Presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology in Chicago, IL, May 31-June 3, 2003, and the 21st Annual Chemotherapy Foundation Symposium New York, NY, November 12-15, 2003.

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

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