Lymphadenectomy (LND) is a well-established practice in many urologic malignancies; however, its role in renal cell carcinoma (RCC) is less clear. Our primary objective was to determine whether LND impacted survival in patients with fully resected high-risk RCC.
Patients with fully resected high-risk, non-metastatic RCC were randomized to adjuvant sorafenib, sunitinib, or placebo in the Adjuvant Sorafenib and Sunitinib for Unfavorable Renal Carcinoma (ASSURE) trial. LND was performed for cN+ disease or at surgeon discretion. LND patients were compared to patients in the trial who did not undergo LND. The primary outcome was overall survival (OS) associated with LND. Secondary outcomes were disease free survival (DFS), factors associated with performing LND, and surgical complications.
701 (36.1%) patients from ASSURE (n=1943) underwent LND, including all resectable patients with cN+ and 30.1% of those with cN0 disease. The median number of lymph nodes removed was 3 (IQR 1-8); the rate of pN+ disease in the LND group was 23.4%. There was no OS benefit for LND relative to no LND (HR 1.14; 95% CI 0.93-1.39, p = 0.20). In pN+ patients who underwent LND, no improvement in OS/DFS was observed with adjuvant therapy relative to placebo. LND did not confer increased risk for surgical complications (14.2% vs. 13.4%, p = 0.63).
The benefit of LND in patients undergoing surgery for high-risk RCC remains uncertain. Future strategies for answering this question should include a prospective trial randomizing patients with high-risk RCC to specific LND templates.
The Journal of urology. 2017 Jul 17 [Epub ahead of print]
Benjamin T Ristau, Judi Manola, Naomi B Haas, Daniel Y C Heng, Edward M Messing, Christopher G Wood, Christopher J Kane, Robert S DiPaola, Robert G Uzzo
Fox Chase Cancer Center, Temple Health, Philadelphia, PA, USA. Electronic address: ., Dana-Farber Cancer Institute - ECOG-ACRIN Biostatistics Center, Boston, MA, USA., Abramson Cancer Center of The University of Pennsylvania, Philadelphia, PA, USA., Tom Baker Cancer Center, University of Calgary, Calgary, Alberta, Canada., Department of Urology, University of Rochester, Rochester, NY, USA., The University of Texas MD Anderson Cancer Center, Houston, TX, USA., Moores Cancer Center, University of California, San Diego, La Jolla, CA, USA., University of Kentucky College of Medicine, Lexington, KY, USA (current location); Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, USA (former location)., Fox Chase Cancer Center, Temple Health, Philadelphia, PA, USA.