University of Southern California, Los Angeles, CA, USA.
UT Southwestern Medical Center, Dallas, TX, USA.
Eur Urol Oncol. 2023 Dec;6(6):604-610. doi: 10.1016/j.euo.2023.03.003. Epub 2023 Mar 31.
Immune checkpoint inhibitors (ICIs) are now a mainstay of metastatic renal cell carcinoma (RCC) management with five current Food and Drug Administration-approved regimens. However, data regarding nephrectomy outcomes following an ICI are limited.
To evaluate the safety and outcomes of nephrectomy following an ICI.
DESIGN, SETTING, AND PARTICIPANTS: A retrospective review was performed of patients with primary locally advanced or metastatic RCC undergoing nephrectomy following an ICI in five US academic centers between January 2011 and September 2021.
Clinical data, perioperative outcomes, and 90-d complications/readmissions were recorded and evaluated by univariate and logistic regression models. Recurrence-free and overall survival probabilities were estimated by the Kaplan-Meier method.
A total of 113 patients with a median (interquartile range) age of 63 (56-69) yr were included. The main ICI regimens were nivolumab ± ipilimumab (n = 85) and pembrolizumab ± axitinib (n = 24). Risk groups included 95% intermediate- and 5% poor-risk patients. Surgical procedures were 109 radical and four partial nephrectomies, including 60 open, 38 robotic, and 14 laparoscopic with five (10%) conversions. Two intraoperative complications were reported (bowel and pancreatic injury). The median operative time, estimated blood loss, and hospital stay were 3 h, 250 ml, and 3 d, respectively. A complete pathologic response (ypT0N0) was noted in six (5%) patients. The 90-d complication rate was 24%, with 12 (11%) patients requiring readmission. On a multivariable analysis, two or more risk factors (odds ratio [OR] 2.91, 95% confidence interval [CI]: 1.09, 7.42) and pathologic T stage ≥T3 (OR 4.21, 95% CI: 1.13-15.8) were independently associated with a higher 90-d complication rate. The 3-yr estimated overall survival and recurrence-free survival rates were 82% and 47%, respectively. Limitations include the retrospective nature and heterogeneous cohort in terms of clinicopathologic characteristics and ICI regimens received.
Nephrectomy following ICI therapy is feasible and a potential consolidative therapy option in select patients. Further research in the neoadjuvant setting is also warranted.
This study evaluates the outcomes of kidney surgery following immune checkpoint inhibitor therapy (mainly nivolumab and ipilimumab or pembrolizumab and axitinib) for patients with advanced kidney cancer. We utilized data from five academic centers across the USA and found that surgery in this setting did not have more complications or returns to the hospital than similar surgeries, indicating that it is a safe and feasible procedure at this time.
免疫检查点抑制剂（ICI）现已成为转移性肾细胞癌（RCC）管理的主要方法，目前有五种获得美国食品和药物管理局批准的方案。然而，关于 ICI 后肾切除术结果的数据有限。
评估 ICI 后肾切除术的安全性和结果。
设计、地点和参与者：对 2011 年 1 月至 2021 年 9 月期间，美国五家学术中心的接受 ICI 治疗的局部晚期或转移性原发性 RCC 患者进行了回顾性研究，这些患者在接受 ICI 后接受了肾切除术。
记录并通过单变量和逻辑回归模型评估临床数据、围手术期结果和 90 天并发症/再入院情况。通过 Kaplan-Meier 方法估计无复发生存率和总生存率。
共纳入 113 例中位（四分位间距）年龄为 63（56-69）岁的患者。主要的 ICI 方案为纳武单抗±伊匹单抗（n=85）和帕博利珠单抗±阿昔替尼（n=24）。风险组包括 95%的中危和 5%的高危患者。手术方式为 109 例根治性和 4 例部分肾切除术，其中 60 例为开放性手术，38 例为机器人手术，14 例为腹腔镜手术，5 例（10%）转为开放性手术。报告了 2 例术中并发症（肠和胰腺损伤）。中位手术时间、估计失血量和住院时间分别为 3 小时、250 毫升和 3 天。6 例（5%）患者出现完全病理缓解（ypT0N0）。90 天并发症发生率为 24%，12 例（11%）患者需要再次入院。多变量分析显示，两个或更多危险因素（比值比[OR]2.91，95%置信区间[CI]：1.09，7.42）和病理 T 分期≥T3（OR 4.21，95%CI：1.13-15.8）与更高的 90 天并发症发生率独立相关。3 年估计总生存率和无复发生存率分别为 82%和 47%。局限性包括回顾性研究性质以及接受的临床病理特征和 ICI 方案的异质性队列。
ICI 治疗后肾切除术是可行的，对于某些患者来说是一种潜在的巩固性治疗选择。在新辅助治疗环境中也需要进一步研究。
本研究评估了免疫检查点抑制剂（ICI）治疗晚期肾癌患者后进行肾脏手术的结果（主要是纳武单抗和伊匹单抗或帕博利珠单抗和阿昔替尼）。我们利用了来自美国五家学术中心的数据，发现与类似手术相比，该环境中的手术并没有更多的并发症或再次住院，这表明目前该手术是安全可行的。
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