Double-blind, randomized, phase 2 trial of maintenance sunitinib versus placebo after response to chemotherapy in patients with advanced urothelial carcinoma

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Grivas P.D., Daignault S., Tagawa S.T., Nanus D.M., Stadler W.M., Dreicer R., Kohli M., Petrylak D.P., Vaughn D.J., Bylow K.A., Wong S.G., Sottnik J.L., Keller E.T., Al-Hawary M., Smith D.C., Hussain M.

Cancer 2014 120:5 (692-701)

BACKGROUND Angiogenesis contributes to the progression of urothelial carcinoma (UC). In the current study, the authors investigated the role of maintenance sunitinib in patients with advanced UC. METHODS Patients with locally recurrent/metastatic UC and adequate organ function who achieved stable disease or a partial or complete response after 4 to 6 chemotherapy cycles were randomized to sunitinib at a dose of 50 mg/day (28 days on and 14 days off) or placebo. The primary endpoint was the 6-month progression rate. Secondary endpoints were safety, survival, change in serum vascular endothelial growth factor (VEGF)/soluble VEGF receptor-2 (sVEGFR2), and the activity of sunitinib in patients who developed disease progression while receiving placebo. A total of 38 eligible patients per treatment arm were required to select better therapy with 90% probability (? =.05) … (ver más)


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