The Outcome of Patients Treated with Sunitinib Prior to Planned Nephrectomy in Metastatic Clear Cell Renal Cancer
The Outcome of Patients Treated with Sunitinib Prior to Planned Nephrectomy in Metastatic Clear Cell Renal Cancer
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DOI：
10.1016/j.eururo.2011.05.028
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发表时间：
2011-09-01
期刊：
影响因子：
23.4
通讯作者：
Bex, Axel
中科院分区：
文献类型：
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作者：
Powles, Thomas;Blank, Christian;Bex, Axel
工作背景：细胞减灭性肾切除术在转移性透明细胞肾细胞癌（ccRCC）中的作用是有争议的。目的：确定在计划的肾切除术之前接受舒尼替尼的转移性ccRCC患者的结局。设计、设置和参与者：该研究结合了两项前瞻性2期研究的数据，这些研究评估了前期舒尼替尼（12-16周）肾切除术前在先前未经治疗的转移性肾细胞癌（RCC）患者。围手术期停用舒尼替尼干预：舒尼替尼50 mg，每周6个周期结果和局限性：21名患者（32%）患有纪念斯隆-凯特琳癌症中心（MSKCC）低风险疾病; 45例（68%）有中度风险疾病。19例（29%）未行肾切除术，最常见的原因是疾病进展（n = 12）。队列的PFS为6.3个月（95%置信区间[CI]，5.1-8.5）。17例（36%）患者在治疗中断期间进展，其中13例（76%）在重新开始舒尼替尼治疗后稳定。队列的OS为15.2个月（95% CI，10.3-NA）。中度MSKCC风险组的OS显著长于低风险组（分别为26.0个月[95%CI，13.6-NA]和9.0个月[95%CI，5.8-20.5]; p < 0.01）。在多变量分析中，计划肾切除术前的疾病进展（风险比[HR]：5.34; 95%CI，3.17-13.27）、高Fuhrman分级（HR 3.27; 95%CI，1.38-7.72）和MSKCC诊断时风险低（HR 4.75; 95%CI，2.05-11.02）与生存期短相关（p < 0.01）。然而，在没有随机研究，这是不可能确定这种方法是benefit.Conclusions：前期舒尼替尼之前，计划肾切除术中危疾病与中位生存期>2年，尽管在治疗中断频繁进展。计划手术前转移部位的进展和MSKCC低风险疾病与不良结局相关。(C)2011年欧洲泌尿外科协会。Elsevier B. V.出版，保留所有权利。
Background: The role of cytoreductive nephrectomy in metastatic clear cell renal cell carcinoma (ccRCC) is controversial.Objective: To determine the outcome of patients with metastatic ccRCC who receive sunitinib prior to planned nephrectomy.Design, setting, and participants: The study combined the data from two prospective phase 2 studies that assessed upfront sunitinib (12-16 wk) prior to nephrectomy in previously untreated patients with metastatic renal cell carcinoma (RCC). Sunitinib was discontinued during the perioperative period (median: 29 d).Intervention: Sunitinib 50 mg in six weekly cycles (4 wk on, 2 wk off).Measurements: Progression-free (PFS) and overall survival (OS) using the Kaplan-Meier method.Results and limitations: Twenty-one patients (32%) had Memorial Sloan-Kettering Cancer Centre (MSKCC) poor-risk disease; 45 (68%) had intermediate-risk disease. Nephrectomy was not performed in 19 (29%), most commonly due to disease progression (n = 12). The PFS for the cohort was 6.3 mo (95% confidence interval [CI], 5.1-8.5). Seventeen (36%) patients progressed during the treatment break, 13 (76%) of whom stabilised upon reinitiating of sunitinib. The OS for the cohort was 15.2 mo (95% CI, 10.3-NA). The OS for the intermediate MSKCC risk group was significantly longer than that for the poor-risk group (26.0 mo [95% CI, 13.6-NA] and 9.0 mo [95% CI, 5.8-20.5], respectively; p < 0.01). In multivariate analysis, progression of disease prior to planned nephrectomy (hazard ratio [HR]: 5.34; 95% CI, 3.17-13.27), high Fuhrman grade (HR 3.27; 95% CI, 1.38-7.72), and MSKCC poor risk at diagnosis (HR 4.75; 95% CI, 2.05-11.02) were associated with short survival (p < 0.01). However, in the absence of randomised studies it is not possible to determine if this approach is beneficial.Conclusions: Upfront sunitinib prior to planned nephrectomy in intermediate-risk disease is associated with a median survival of >2 yr despite frequent progression during treatment break. Progression in metastatic sites prior to planned surgery and MSKCC poor-risk disease was associated with a poor outcome. (C) 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved.