研究动态
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免疫检查点抑制剂治疗后的肾切除手术围手术期并发症和肿瘤学结果:一个多中心协作研究。

Perioperative Complications and Oncologic Outcomes of Nephrectomy Following Immune Checkpoint Inhibitor Therapy: A Multicenter Collaborative Study.

发表日期:2023 Mar 31
作者: Wesley Yip, Alireza Ghoreifi, Thomas Gerald, Randall Lee, Jeffrey Howard, Aeen Asghar, Abhinav Khanna, Jie Cai, Manju Aron, Inderbir Gill, R Houston Thompson, Robert Uzzo, Vitaly Margulis, Nirmish Singla, Hooman Djaladat
来源: EUROPEAN UROLOGY ONCOLOGY

摘要:

免疫检查点抑制剂(ICIs)是转移性肾细胞癌(RCC)治疗的主要手段,目前有5种被美国食品和药物管理局批准的方案。然而,有关接受ICIs后肾切除的数据仍较有限。本研究的目的是评估接受ICIs后肾切除的安全性和效果。我们对在美国5个学术中心接受ICIs后进行原发性局部晚期或转移性RCC肾切除的患者进行了回顾性研究,时间跨度从2011年1月至2021年9月。采集并采用单变量和逻辑回归模型进行评估的临床数据、围手术期结果和90天并发症/再入院情况。采用Kaplan-Meier方法估计无复发和总体存活率。本研究共纳入了113名患者,中位(四分位)年龄为63(56-69)岁。主要ICIs方案包括尼伏单抗±伊匹单抗(n = 85)和帕博利珠单抗±阿希替尼(n = 24)。95%中等危险和5%差危险的患者居多。手术方式包括109例根治性肾切除和4例部分肾切除,其中包括60例开放式手术、38例机器人手术和14例腹腔镜手术,其中5例(10%)需要转换手术方式。手术中报告了2例并发症(肠道和胰腺损伤)。手术时间、估计失血量和住院时间的中位数分别为3个小时、250毫升和3天。6(5%)名患者观察到完全病理学反应(ypT0N0)。90天的并发症率为24%,其中12例(11%)患者需要重新入院。在多变量分析中,2个或多个风险因素(比值比[OR] 2.91,95%置信区间[CI]:1.09、7.42)和病理分期-T≥T3(OR 4.21,95%CI:1.13-15.8)与更高的90天并发症率独立相关。3年总体生存率和无复发生存率的估计率分别为82%和47%。研究限制包括回顾性的特质和临床病理学特征和接受ICIs治疗的异质性群体。换言之,接受ICIs疗法后进行肾切除是可行的,并且在选择患者中是一种潜在的巩固治疗方案。此外,我们也需要在新辅助治疗方面开展更多研究。本研究评估了免疫检查点抑制剂疗法(主要是尼伏单抗和伊匹单抗,或帕博利珠单抗和阿希替尼)后肾脏手术的结果,针对转移性肾癌患者。我们利用美国的五个学术中心的数据,发现在这种情况下,手术并没有比类似手术更多的并发症或返回医院的情况发生,这表明在目前这个时期,手术是安全可行的。版权所有©2023 European Association of Urology。由Elsevier B.V.出版。保留所有权利。
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.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.Copyright © 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.