MIAMI – Final overall survival results of the RECORD-3 trial are consistent with initial results and further support the standard sequence of sunitinib followed by everolimus at the time of disease progression in patients with metastatic renal cell carcinoma (mRCC), a study presented at the 14th International Kidney Cancer Symposium 2015 (IKCS) has shown.

“Standard treatment options for patients with mRCC are anti-VEGF agents and mTOR inhibitors,” Jennifer J. Knox, of Princess Margaret Cancer Center in Toronto, Canada, said during the poster presentation. “Current treatment guidelines for patients with mRCC recommend a first-line VEGF inhibitor, including the EGFR TKI sunitinib, followed by an agent such as the mTOR inhibitor everolimus at progression.”

For the multicenter, phase 2 RECORD-3 trial, researchers enrolled 471 patients with clear non-clear cell mRCC who had not received prior systemic therapy. Participants were randomly assigned 1:1 to receive first-line everolimus 10 mg/day or sunitinib 50 mg/day in a 4 weeks on, 2 weeks off schedule until first occurrence of disease progression. Patients then crossed over and received the alternate drug until second occurrence of disease progression.

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Initial results showed that everolimus followed by sunitinib was not noninferior to sunitinib followed by everolimus in terms of progression-free survival.

Final results showed that median progression-free survival was 21.7 months (95% CI, 15.1 – 26.7) for everolimus followed by sunitinib and 22.2 months (95% CI, 16.0 – 29.8) for sunitinib followed by everolimus (HR, 1.2; 95% CI, 0.9 – 1.6). Median overall survival was 22.4 months (95% CI, 18.6 – 33.3) and 29.5 months (95% CI, 22.8 – 33.1) for the everolimus-sunitinib and sunitinib-everolimus groups, respectively (HR, 1.1; 95% CI, 0.9 – 1.4).

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“Median overall survival was similar between treatment arms for patients with predominantly clear cell RCC and predominantly non-clear cell mRCC,” Dr. Knox noted.

In regard to safety, 62% of patients who received everolimus followed by sunitinib experienced grade 3 or 4 adverse events compared with 71% in the sunitinib followed by everolimus treatment arm.


  1. Knox JJ, Barrios CH, Kim TM, et al. Final overall survival analysis for the RECORD-3 study of first-line everolimus followed by sunitinib versus first-line sunitinib followed by everolimus in metastatic RCC (mRCC) [abstract]. BJU Int. 2015. doi: 10.1111/bju.13365.