The potential role for neoadjuvant therapy in renal cell carcinoma.

Surgical resection remains the standard of care for clini- cally localized renal cell carcinoma (RCC). Nearly 1 in 4 patients will have a recurrence after surgery performed with curative intent, and stand to benefit from additional therapy. Currently, no proven adjuvant or neoadjuvant therapies are available. A number of phase 3 adjuvant therapy trials are ongoing that are evaluating small-molecule drugs approved for metastatic RCC. The outcomes of these trials may provide insights for designing future phase 3 neoadjuvant therapy trials. Several phase 2 neoadjuvant trials for RCC have recently been completed or are ongoing. These trials have established the safety and response rates associated with several agents, and will pave the way for future phase 3 trials of neoadjuvant therapy for RCC. Neoadjuvant therapies may be useful for decreasing the risk of recurrence after surgery, maximiz- ing nephron sparing, and evaluating molecular effects of targeted therapies in human tumors.