Adjuvant treatment for renal cell carcinoma: do we finally have a major breakthrough?

Clinical parameters can be used to identify patients at greatest risk for recurrence following nephrectomy for clinically localized renal cell carcinoma (RCC). Molecular tools are being developed to improve risk stratification. An increasing list of available treatments for metastatic RCC continues to provide hope that an effective adjuvant therapy will be identified for patients with high-risk, clinically localized disease. In a phase 3 adjuvant therapy trial (S-TRAC), sunitinib increased median disease-free survival in patients with clear cell RCC who were at very high risk. This is the first positive phase 3 adjuvant therapy trial using a targeted therapy. However, a much larger phase 3 trial comparing sunitinib, sorafenib, and placebo (ASSURE) was negative. Careful review of recent adjuvant therapy trials reveals insights about who may benefit from adjuvant therapy and provides lessons for future trial design.