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Findings seen in clear cell renal cell carcinoma patients at very high disease risk after nephrectomy from EVEREST trial

For patients with clear cell renal cell carcinoma (RCC) at very high risk for recurrence, adjuvant everolimus is associated with significantly improved recurrence-free survival, according to a study presented at the annual meeting of the European Society for Medical Oncology, held from Oct. 20 to 24 in Madrid.

Primo N. Lara, M.D., from the University of California Davis Comprehensive Cancer Center in Sacramento, and colleagues reported the results of an analysis of patients with clear cell RCC with very high-risk disease after nephrectomy from the EVEREST phase 3 trial. A total of 699 patients were eligible: 348 were assigned to everolimus and 351 to placebo.

The researchers found that 47 and 64 percent of patients assigned to everolimus and placebo, respectively, completed all treatment as planned. Grade 3+ adverse events were more frequent with everolimus than with placebo (42 versus 8 percent). Significant recurrence-free survival improvement was seen with adjuvant everolimus in intention-to-treat and per-protocol cohorts (hazard ratio, 0.80 for both cohorts).

“The focus on patients with clear cell RCC at very high risk for recurrence allows researchers to better interpret the results of EVEREST in the context of the modestly positive S-TRAC and KN546 trials,” Lara said in a statement.

Several authors disclosed ties to biopharmaceutical companies, including Novartis, which manufactures everolimus.


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