MIAMI – Everolimus continued to add clinical benefit in the second-line setting after treatment with sunitinib and other first-line therapy in patients with metastatic renal cell carcinoma (mRCC), a study presented at the 14th International Kidney Cancer Symposium (IKCS) has shown.1

In the pivotal RECORD-1 trial, everolimus was superior to placebo in patients with mRCC previously treated with sunitinib, sorafenib, or both. For the phase 2 RECORD-4 trial, researchers sought to evaluate everolimus as second-line therapy in patients with mRCC who had received prior first-line therapy with cytokines, sunitinib, or anti-vascular endothelial growth factor (VEGF) therapy other than sunitinib.

Researchers enrolled 134 patients with clear cell mRCC who had previously undergone total or partial nephrectomy and had received sunitinib, other anti-VEGF therapy (eg, sorafenib, bevacizumab, pazopanib), or cytokines.

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Results showed that median overall progression-free survival was 7.8 months (95% CI, 5.7 – 11.0). Among those who had received prior sunitinib, median progression-free survival was 5.7 months (95% CI, 3.7 – 11.3) compared with 7.8 months (95% CI, 5.7 – 11.0) months among those who had received other prior anti-VEGF therapies. Patients who had received prior cytokine therapy had a median progression-free survival was 12.9 months (95% CI, 2.6 – NE).

“Progression-free survival benefit with second-line everolimus was observed in patients treated with first-line sunitinib and with various other first-line anti-VEGF therapies,” Thomas Cosgriff, MD, of the Crescent City Research Consortium in Marrero, LA, said during the poster presentation.

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Researchers found an overall response rate of 7.5% (95% CI, 3.6 – 13.3), with most patients achieving stable disease as best overall response.

In regard to safety, 56% of patients experienced grade 3 or 4 adverse events, which was consistent with previous safety results in studies evaluating everolimus.

“The results from RECORD-4 reinforce the clinical benefit of everolimus in the second-line setting after sunitinib and other first-line therapies,” Dr. Cosgriff concluded.


  1. Cosgriff T, Alyasova A, Ye D, et al. RECORD-4: a multicenter phase 2 trial of second-line everolimus (EVE) in patients with metastatic renal cell carcinoma (mRCC) [accepted abstract]. BJU Int. 2015. doi: 10.1111/bju.13365.