Renal cancer is expected to affect approximately 60,000 people in the United States each year.  It accounts for up to 3% of all adult cancers and is the seventh most common cancer in men and eighth most common cancer in women.  Renal cell carcinoma (RCC) comprises nearly 90% of these cases and has an overall five-year survival rate of 70%. In patients with Stage IV metastatic disease (mRCC), five-year survival rates are lowest at only about 20%. A growing need for improved management of this disease has led to the investigation of different treatment strategies utilizing systemic targeted therapies.1

According to a recently published population-based analysis using Surveillance, Epidemiology, and End Results (SEER), the incidence of renal cancer has more than doubled from 1976 to 2006. Moreover, the rate of increase has been various among different age groups, genders, and ethnic backgrounds. The increase in annual incidence rates was highest among young patients (20 to 39 years of age) and rose from 4.5% to 5.2%, while patients 79 years of age and older experienced decreased incidence rates from 6.7% to 0.8%.  The proportion of patients getting diagnosed at 65 years of age or younger has decreased by nearly 10% from 1991 to 2006. This is believed to be the combined result of early detection through cross-sectional imaging and earlier exposure to environmental risk factors such as obesity, unhealthy diet, and hypertension. The incidence rates in female patients as well as nonwhite patients also increased.  The implications of these findings point to an immediate and growing need for the development of targeted therapies and treatment regimens that can prolong life while minimizing toxicity.2   

Currently, RCC patients with localized disease (Stage I through III) are primarily treated with surgical resection, partial nephrectomy, or radical nephrectomy. No systemic therapies have been shown to reduce the risk of recurrence, and the benefit of adjuvant therapy has not been established. For patients with Stage IV mRCC, primary treatment consists of cytoreductive nephrectomy, and possible surgical resection of local and distant metastases followed by systemic therapy. The NCCN (National Comprehensive Cancer Network®) Kidney Cancer Panel recommends cytokine therapy with IL-2 as first-line treatment, however, long-lasting complete response or partial remissions have only been observed in a small subset of patients. The use of IL-2 is associated with significant toxicities including capillary-leak syndrome and serious infection, and is limited to patients with good performance status and few medical co-morbidities.1,3

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