To study the effects on adjuvant therapy in patients with sarcomatoid RCC enrolled in the randomized phase 3 clinical trial E2805.
The original trial (E2805) is a randomized, double-blinded phase 3 clinical trial comparing outcomes in 1,943 patients with RCC accrued between 2006 and 2010, and treated with up to 1 year of adjuvant placebo, sunitinib, or sorafenib. The current study analyses the cohort of patients with sRCC that participated in E2805.
171 patients (8.8%) had sarcomatoid features. 52 patients received sunitinib, 58 received sorafenib, and 61 received placebo. Most patients were pT3-4 (71.1%, 63.7%, 70.5%, respectively) and 17.3%, 19.0%, 27.9% had pathologically positive lymph nodes. 59.6%, 62.1%, and 62.3% of the patients were UCLA UISS very-high risk. Forty-nine percent of patients with subsequent development of metastatic disease recurred in the lung, followed by 30% in the lymph nodes, and 13% in the liver. There was a high local recurrence rate in the renal bed (16%, 29%, and 18%, respectively). Five-year DFS rates were 33.6%, 36.0%, and 27.8%, for sunitinib, sorafenib and placebo, respectively; [HR (95% CI) 0.74(0.45-1.20) for sunitinib versus placebo, and HR 0.82(0.53-1.28) for sorafenib versus placebo].
Adjuvant therapy with sunitinib or sorafenib did not show an improvement of DFS or OS in patients with RCC with sarcomatoid features.

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