高危非转移性肾细胞癌的腹膜后淋巴结清扫术：ASSURE（ECOG-ACRIN 2805）辅助试验分析
Retroperitoneal Lymphadenectomy for High Risk, Nonmetastatic Renal Cell Carcinoma: An Analysis of the ASSURE (ECOG-ACRIN 2805) Adjuvant Trial.
作者信息
Ristau Benjamin T, Manola Judi, Haas Naomi B, Heng Daniel Y C, Messing Edward M, Wood Christopher G, Kane Christopher J, DiPaola Robert S, Uzzo Robert G
机构信息
Fox Chase Cancer Center, Temple Health, Philadelphia, Pennsylvania.
ECOG-ACRIN Biostatistics Center, Dana-Farber Cancer Institute, Boston, Massachusetts.
出版信息
J Urol. 2018 Jan;199(1):53-59. doi: 10.1016/j.juro.2017.07.042. Epub 2017 Jul 18.
PURPOSE
Lymphadenectomy is a well established practice for many urological malignancies but its role in renal cell carcinoma is less clear. Our primary objective was to determine whether lymphadenectomy impacted survival in patients with fully resected, high risk renal cell carcinoma.
MATERIALS AND METHODS
Patients with fully resected, high risk, nonmetastatic renal cell carcinoma were randomized to adjuvant sorafenib, sunitinib or placebo in the ASSURE (Adjuvant Sorafenib and Sunitinib for Unfavorable Renal Carcinoma) trial. Lymphadenectomy was performed for cN+ disease or at surgeon discretion. Patients treated with lymphadenectomy were compared to patients in the trial who did not undergo lymphadenectomy. The primary outcome was overall survival associated with lymphadenectomy. Secondary outcomes were disease free survival, factors associated with performing lymphadenectomy and surgical complications.
RESULTS
Of the 1,943 patients in ASSURE 701 (36.1%) underwent lymphadenectomy, including all resectable patients with cN+ and 30.1% of those with cN0 disease. A median of 3 lymph nodes (IQR 1-8) were removed and the rate of pN+ disease in the lymphadenectomy group was 23.4%. There was no overall survival benefit for lymphadenectomy relative to no lymphadenectomy (HR 1.14, 95% CI 0.93-1.39, p = 0.20). In patients with pN+ disease who underwent lymphadenectomy no improvement in overall or disease-free survival was observed for adjuvant therapy relative to placebo. Lymphadenectomy did not confer an increased risk of surgical complications (14.2% vs 13.4%, p = 0.63).
CONCLUSIONS
The benefit of lymphadenectomy in patients undergoing surgery for high risk renal cell carcinoma remains uncertain. Future strategies to answer this question should include a prospective trial in which patients with high risk renal cell carcinoma are randomized to specific lymphadenectomy templates.
目的
淋巴结清扫术是许多泌尿系统恶性肿瘤的既定治疗方法，但其在肾细胞癌中的作用尚不清楚。我们的主要目的是确定淋巴结清扫术是否会影响完全切除的高危肾细胞癌患者的生存率。
材料与方法
在ASSURE（辅助索拉非尼和舒尼替尼治疗高危肾癌）试验中，将完全切除的高危、非转移性肾细胞癌患者随机分为接受辅助索拉非尼、舒尼替尼或安慰剂治疗。对于cN+疾病或由外科医生酌情决定进行淋巴结清扫术。将接受淋巴结清扫术治疗的患者与试验中未接受淋巴结清扫术的患者进行比较。主要结局是与淋巴结清扫术相关的总生存期。次要结局是无病生存期、与进行淋巴结清扫术相关的因素以及手术并发症。
结果
在ASSURE试验的1943例患者中，701例（36.1%）接受了淋巴结清扫术，包括所有可切除的cN+患者以及30.1%的cN0疾病患者。中位切除3个淋巴结（四分位间距1-8），淋巴结清扫术组的pN+疾病发生率为23.4%。与未进行淋巴结清扫术相比，淋巴结清扫术对总生存期无益处（风险比1.14，95%置信区间为0.93-1.39，p = 0.20）。在接受淋巴结清扫术的pN+疾病患者中，相对于安慰剂，辅助治疗在总生存期或无病生存期方面未观察到改善。淋巴结清扫术并未增加手术并发症的风险（14.2%对13.4%，p = 0.63）。
结论
淋巴结清扫术对高危肾细胞癌手术患者的益处仍不确定。未来回答这个问题的策略应包括一项前瞻性试验，将高危肾细胞癌患者随机分配到特定的淋巴结清扫模板中。
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