According to a new study published in the journal Annals of Oncology, researchers in Australia have found that an alternating regimen of sunitinib and everolimus lacked clinical activity, despite being feasible and safe, in the treatment of patients with advanced renal cell carcinoma.

For the single-arm, two-stage, multicenter, phase 2 study, researchers enrolled 55 patients with favorable or intermediate risk advanced renal cell carcinoma and gave them 12-week cycles of sunitinib 50mg daily for 4 weeks on, 2 weeks off, alternating with everolimus 10mg daily for 5 weeks on, 1 week off, until disease progression or unacceptable toxicity.

Results showed a 6-month progression-free survival rate of 53% (95% CI: 40-66) and a tumor response rate of 13% (95% CI: 2-22).

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All patients who experienced a response achieved a partial response. After a median follow-up of 20 months, the median progression-free survival was 8 months (95% CI: 5-10) and the median overall survival was 17 months (95% CI: 12 to undefined). In regard to safety, all adverse events were consistent with previous studies for each agent.

The findings suggest that the current approach of continuing anti-VEGF therapy until disease progression or unacceptable toxicity before changing treatment should be continued in clinical practice.


  1. Davis ID, et al. EVERSUN: a phase 2 trial of alternating sunitinib and everolimus as first line therapy for advanced renal cell carcinoma. Ann Oncol. February 20, 2015. [Epub ahead of print]. doi: 10.1093/annonc/mdv078