Adjuvant therapy in renal cell carcinoma: Where are we?

This review summarises available data and describes planned clinical trials designed to evaluate the potential of targeted agents as adjuvant therapy for renal cell carcinoma (RCC). Advanced RCC is refractory to standard cytotoxic chemotherapy, and clinical trials of adjuvant cytokine therapy in this therapeutic setting have not yet demonstrated clear evidence of clinical benefit. However, molecularly targeted therapies may offer a new approach for adjuvant therapy of this disease. Sorafenib (Nexavar (R) Bayer Healthcare, West Haven, CT, USA) and sunitinib (Sutent (R)) Pfizer Inc, New York, NY, USA) are candidates for adjuvant therapy, because they are efficacious in the treatment of metastatic RCC and have side-effect profiles that can usually be well managed during long-term administration. The clinical benefit and tolerability of these agents as adjuvant therapies are being investigated in three ongoing phase 3 trials: ASSURE (adjuvant sorafenib or sunitinib in unfavourable renal cell carcinoma; Eastern Cooperative Oncology Group 2805), STAR (sunitinib trial in adjuvant renal cancer) and SORCE (a phase 3, randomised, double-blind, controlled study comparing sorafenib with placebo in patients with resected primary renal cell carcinoma at high or intermediate risk of relapse). The results of these studies will address important clinical and translational questions, the answers to which may help define future treatment strategies and guide treatments towards the most appropriate patients. (c) 2007 European Association of Urology. Published by Elsevier B.V. All rights reserved.