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Ristau BT, Manola J, Haas NB, Heng DY, Messing EM, Wood CG, Kane CJ, DiPaola RS, Uzzo RG
Retroperitoneal Lymphadenectomy in High-Risk Non-Metastatic Renal Cell Carcinoma: An Analysis of the ASSURE (ECOG-ACRIN 2805) Adjuvant Trial
J Urol (2017) In process.
Abstract
PURPOSE: 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 AND METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.
Note
Publication Date: 2017-07-17.
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Last updated on Thursday, November 02, 2017