The progression-free survival benefit of second-line everolimus after first-line sunitinib or other anti-vascular endothelial growth factor (VEGF) therapies in patients with metastatic renal cell carcinoma (mRCC) was confirmed, according to results of the RECORD-4 trial published in the journal Annals of Oncology has shown.1

Because the RECORD-1 trial demonstrated clinical benefit of everolimus in patients with mRCC previously treated with sunitinib, sorafenib, or both, as well as prior treatment with cytokines, bevacizumab, and chemotherapy, researchers sought to evaluate everolimus in a purely second-line setting.

For the study, researchers enrolled 134 patients with clear cell mRCC who had received first-line therapy with sunitinib, other anti-VEGF agents, or cytokines. Of those, 58 patients had received sunitinib, 23 received sorafenib, 16 received bevacizumab, 13 pazopanib, and 14 had received cytokines.

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Fifty-two percent of patients were of favorable Memorial Sloan Kettering Cancer Center (MSKCC) risk while 37% were of intermediate MSKCC risk. All patients received everolimus 10 mg orally daily until disease progression or unacceptable toxicity.

Results showed that the overall median progression-free survival was 7.8 months (95% CI, 3.7 – 11.3). For patients who had received previous sunitinib, the median progression-free survival was 5.7 months (95% CI, 3.7 – 11.3), vs 7.8 months (95% CI, 5.7 – 11.0) among patients who had received other previous anti-VEGF therapy, and 12.9 months (95% CI, 2.6 – not estimable) with previous cytokines.

Median overall survival was 23.8 months (95% CI, 13.7 – not estimable), 17.2 months (95% CI, 11.9 – not estimable), and not estimable (95% CI, 15.9 – not estimable), respectively.

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In terms of response, 67% of all patients achieved stable disease as their best response.

A total of 56% of patients experienced a grade 3 or adverse event. Researchers found that the safety profile of everolimus was consistent with previous findings.


  1. Motzer RJ, Alyasova A, Ye D, et al. Phase 2 trial of second-line everolimus in patients with metastatic renal cell carcinoma (RECORD-4) [published online ahead of print December 17, 2015]. Ann Oncol. doi: 10.1093/annonc/mdv612.