Sunitinib may improve disease-free survival (DFS) compared with placebo among patients with locoregional renal cell carcinoma (RCC) at high risk of recurrence post-nephrectomy, according to a study published in European Urology.1

For the phase 3 S-TRAC study, researchers randomly assigned 615 patients to receive adjuvant sunitinib or placebo. Eligible patients had non-metastatic RCC defined as T3 or T4, no nodal involvement, no previous systemic therapy prior to nephrectomy, and no evidence of residual disease. Seventy-one percent of patients in the sunitinib arm received 6 or more cycles; 56% completed the treatment.

Primary results of the trial showed that adjuvant sunitinib significantly prolonged DFS for the overall study population. For this analysis, researchers evaluated DFS, overall survival (OS), and recurrence patterns among subgroups.

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Patients in all subgroups who received adjuvant sunitinib had a DFS benefit compared with placebo, including patients who were at a higher risk of recurrence (hazard ratio [HR], 0.74; 95% CI, 0.55-0.99; P = .04), had a neutrophil-to-lymphocyte ratio of 3 or less (HR, 0.72; 95% CI, 0.54-0.95; P = .02), and had a Fuhrman grade of 3 or 4 (HR, 0.73; 95% CI, 0.55-0.98; P = .04).

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Of the 615 study patients, 97 and 122 in the sunitinib and placebo arms relapsed, respectively, with distant metastases most common in the lungs, lymph nodes, and liver.

At the median follow-up of 6.6 years and 6.7 years in the sunitinib and placebo arms, respectively, median overall survival (OS) was not reached (HR, 0.92; 95% CI, 0.66-1.28; P = .6).

The authors concluded that “[t]he DFS benefit with adjuvant sunitinib in patients with locoregional RCC at high risk of tumor recurrence after nephrectomy as demonstrated in the primary analysis for S-TRAC was supported by subgroup analysis.”


  1. Motzer RJ, Ravaud A, Patard JJ, et al. Adjuvant sunitinib for high-risk renal cell carcinoma after nephrectomy: subgroup analyses and updated overall survival results. Euro Urol. 2017 Sep 28. doi: 10.1016/j.eururo.2017.09.008 [Epub ahead of print]