Adjuvant Treatment for High-Risk Clear Cell Renal Cancer
In an updated analysis of the phase III ASSURE trial reported in JAMA Oncology, Naomi B. Haas, MD, of Abramson Cancer Center, University of Pennsylvania, and colleagues, found no disease-free or overall survival benefit to adjuvant sunitinib or sorafenib in a high-risk subset of patients with clear cell renal cell carcinoma histology and pT3, pT4, or node-positive disease. ASSURE is reportedly the largest adjuvant study of vascular endothelial growth factor (VEGF) tyrosine kinase inhibitors to date in this setting, and another recent trial showed a disease-free survival benefit with sunitinib in a similar patient population, prompting this secondary analysis.
A total of 1,069 high-risk patients were evaluated. Patients were randomized to receive 1 year of daily sunitinib at 50 mg (n=358), 1 year of daily sorafenib at 800 mg (n=355), or equivalent placebo (n=356). Five-year disease-free survival rates were 47.7% with sunitinib, 49.9% with sorafenib, and 50.0% with placebo. Five-year overall survival rates were 75.2% with sunitinib, 80.2% with sorafenib, and 76.5% with placebo.
“Neither prognostic category of the tumor nor the dose intensity of therapy altered the lack of difference in disease-free survival or overall survival in this population of patients with high-risk clear cell renal cell carcinoma,” the investigators reported.