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Acceptance of sunitinib (Sutent) as standard front-line therapy for patients with low- and intermediate-risk advanced clear-cell renal cell carcinoma (RCC) is based on data from several phase II trials as well as results of a phase III study that demonstrated superior efficacy of sunitinib over interferon α (J Clin Oncol 2009; 27:3584). However, patients with relatively poor prognoses did not meet inclusion criteria for these studies.
To better understand the toxicity and efficacy of sunitinib in “real world” RCC patients, an international group of investigators conducted an industry-funded, expanded-access study involving patients with advanced RCC regardless of histology. The primary objective was to provide sunitinib to patients with adeq…