Multicenter phase 3 trial of adjuvant everolimus after surgery for renal cell carcinoma

Patients undergoing resection of renal cell carcinoma (RCC) are at risk of disease relapse. The multicenter phase 3 EVEREST trial, at 398 centers in the USA, evaluated adjuvant everolimus after nephrectomy for RCC. The 5- year recurrence-free survival rate was 67% with everolimus versus 63% with placebo (sHR 0.85; p=0.051), a difference that did not meet the prespecified p value for significance of 0.044. Recurrence-free survival was longer with everolimus than with placebo in the very-high-risk group (HR 0.79; p=0.022) but not in the intermediate-risk-group (HR 0.99; p=0.96). Grade 3 or higher adverse events occurred in 46% of the patients who received everolimus and 11% of the patients who received placebo.