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.
BJU international. 2021 Sep 04 [Epub ahead of print]
Jose A Karam, Maneka Puligandla, Keith T Flaherty, Robert G Uzzo, Surena F Matin, Michael R Pins, Christopher G Wood, Christopher Kane, Michael A S Jewett, Se Eun Kim, Janice P Dutcher, Robert S DiPaola
The University of Texas MD Anderson Cancer Center, Houston, TX, USA., Dana Farber Cancer Institute - ECOG-ACRIN Biostatistics Center, Boston, MA, USA., Massachusetts General Hospital Cancer Center, Boston, MA, USA., Fox Chase Cancer Center, Philadelphia, PA, USA., Advocate Lutheran General Hospital, Park Ridge, IL, USA., University of California at San Diego, La Jolla, CA, USA., University of Toronto, Toronto, ON, Canada., Cancer Research Foundation Inc, of New York, Chappaqua., University of Kentucky College of Medicine, Lexington, KY, USA.