Adjuvant treatment with sorafenib or sunitinib demonstrated no survival benefit in patients with resected local renal cell carcinoma at high risk for disease recurrence, a study published in the journal The Lancet has shown.1

Sorafenib and sunitinib, 2 vascular endothelial growth factor (VEGF) kinase inhibitors, are frequently used treatment in patients with advanced RCC. Researchers sought to evaluate whether either of these agents would be beneficial in the adjuvant setting.

For the double-blind, placebo-controlled, phase 3 trial, researchers enrolled 226 patients with high-grade T1b or greater and completely resected nonmetastatic RCC. Patients were randomly assigned 1:1:1 to receive sunitinib 50 mg orally daily for 4 weeks of each 6-week cycle, sorafenib 400 mg orally twice daily throughout each cycle, or placebo, for 54 weeks.

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Results showed no significant differences in disease-free survival between the 3 treatment arms. Median disease-free survival was 5.8 years with sunitinib (HR, 1.02; 97.5% CI: 0.85-1.23; P=.8083), 6.1 years with sorafenib (HR, 0.97; 97.5% CI: 0.80-1.17; P=.7184), and 6.6 years with placebo.

In regard to safety, the most frequently reported grade 3 or worse adverse events with sunitinib were fatigue (17%), hypertension (17%), and hand-foot syndrome (15%). The common grade 3 or worse adverse events with sorafenib included hand-foot syndrome, hypertension, and rash.

Of note, 44% of the 438 patients initially enrolled in the sunitinib group and 45% of the 441 patients in the sorafenib group discontinued treatment due to toxicity. This results in reduced starting doses for future participants. Doses were then individually titrated up to the original doses.

“These results provide a strong rationale against the use of these drugs for high-risk kidney cancer in the adjuvant setting and suggest that the biology of cancer recurrence might be independent of angiogenesis,” the authors conclude.


1. Haas NB, Manola J, Uzzo RG, et al. Adjuvant sunitinib or sorafenib for high-risk, non-metastatic renal-cell carcinoma (ECOG-ACRIN E2805): a double-blind, placebo-controlled, randomised, phase 3 trial [published online ahead of print March 8, 2016]. Lancet. doi:10.1016/S0140-6736(16)00559-6.