Everolimus after surgery improves outcomes in high-risk kidney cancer patients

In a study of patients with high-risk renal cell carcinoma, those who took the drug everolimus daily for up to one year after surgery lived longer without their disease returning than those who did not take everolimus. Improvement was seen primarily in patients with very high-risk disease, while patients with intermediate high-risk disease saw no improvement in recurrence-free survival.

The results from the EVEREST study, were presented at the 2022 annual meeting of the American Society of Clinical Oncology (ASCO).

The EVEREST trial enrolled patients who had been diagnosed with intermediate high-risk or very high-risk renal cell carcinoma and who had had their cancer surgically removed by a partial or radical nephrectomy. The study randomized 1,545 of these patients to a year of either everolimus (a 10 mg pill daily) or a placebo, starting within 12 weeks of their surgery.

EVEREST patients with very high-risk disease who took the drug saw a 21% improvement in recurrence-free survival, whereas recurrence-free survival was essentially unchanged for those in the intermediate high-risk group.

Adverse events such as oral mucositis led many patients to discontinue treatment. While, on the everolimus arm, 37 % of patients stopped treatment because of adverse events they were experiencing. In fact, only 45% of patients on the everolimus arm completed all 54 weeks of study treatment, versus 69 % on the placebo arm.

Researchers noted that inspite of more drop outs, they still observed favorable results for everolimus, which brings into question the duration of adjuvant therapy that is actually needed.