ALTERNATIVE REGIMENS FOR UROTHELIAL CANCER

J Clin Oncol. 2009 Sep 28. [Epub ahead of print]

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Randomized Phase II/III Trial Assessing Gemcitabine/Carboplatin and Methotrexate/Carboplatin/Vinblastine in Patients With Advanced Urothelial Cancer "Unfit" for Cisplatin-Based Chemotherapy: Phase II--Results of EORTC Study 30986.

De Santis M, Bellmunt J, Mead G, Kerst JM, Leahy M, Maroto P, Skoneczna I, Marreaud S, de Wit R, Sylvester R.

Kaiser Franz Josef Hospital and Applied Cancer Research-Institution for Translational Research; Central European Anticancer Drug Development Platform; Ludwig Boltzmann-Institute for Applied Cancer Research, Vienna, Austria; Hospital Vall d'Hebrón, Barcelona, Spain; Southampton General Hospital, Southampton; St. James's University Hospital, Leeds, United Kingdom; Netherlands Cancer Institute, Amsterdam; Erasmus University Medical Center, Rotterdam, the Netherlands; University Hospital of San Pablo, Barcelona, Spain; Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw, Poland; and European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.

PURPOSE: There is no standard treatment for patients with advanced urothelial cancer who are ineligible ("unfit") for cisplatin-based chemotherapy (CHT). To compare the activity and safety of two CHT combinations in this patient group, a randomized phase II/III trial was conducted by the EORTC (European Organisation for Research and Treatment of Cancer). We report here the phase II results of the study. PATIENTS AND METHODS: CHT-naïve patients with measurable disease and impaired renal function (30 mL/min <>