Department of Molecular Medicine, Aarhus University Hospital, Aarhus, Denmark.
Department of Oncology, Southern Denmark University Hospital, Esbjerg, Denmark.
BMC Cancer. 2024 Feb 24;24(1):260. doi: 10.1186/s12885-024-11987-3.
Primary tumor removal by cytoreductive nephrectomy in synchronous metastatic renal cell carcinoma patients has been investigated in the context of various treatment regimens. Two randomized controlled trials investigated the role and timing of cytoreductive nephrectomy in the era of targeted therapy and demonstrated that upfront nephrectomy should no longer be performed when patients require systemic therapy. Superiority of checkpoint immunotherapy agents has led to a paradigm change from targeted therapies to immunotherapy-based first-line treatment in patients with primary metastatic disease; thus, deferred cytoreductive nephrectomy needs to be verified in the immunotherapy setting. Furthermore, a need exists for personalizing treatment choices for the individual patient to avoid unnecessary overtreatment.
METHODS/DESIGN: To explore the impact of cytoreductive nephrectomy in this patient group receiving checkpoint immunotherapy, we initiated a randomized, controlled trial comparing deferred cytoreductive nephrectomy with no surgery. The trial integrates a comprehensive translational research program with specimen sampling for biomarker analysis.
The trial aims to show that deferred cytoreductive nephrectomy improves overall survival in patients with synchronous metastatic renal cell carcinoma, and furthermore, to identify relevant biomarkers for personalized renal cancer management.
ClinicalTrials.gov NCT03977571 June 6, 2019.
在各种治疗方案的背景下，已经研究了通过细胞减灭性肾切除术去除同步转移性肾细胞癌患者的原发肿瘤。两项随机对照试验研究了细胞减灭性肾切除术在靶向治疗时代的作用和时机，结果表明，当患者需要系统治疗时，不应再进行 upfront 肾切除术。检查点免疫治疗药物的优越性导致了从靶向治疗到免疫治疗一线治疗的范式转变，对于原发性转移性疾病患者；因此，需要在免疫治疗环境中验证延迟细胞减灭性肾切除术。此外，需要根据个体患者的情况制定治疗选择，以避免不必要的过度治疗。
方法/设计：为了探讨细胞减灭性肾切除术在接受检查点免疫治疗的这组患者中的影响，我们发起了一项随机对照试验，比较了延迟细胞减灭性肾切除术与无手术的效果。该试验整合了一个全面的转化研究计划，包括标本取样进行生物标志物分析。
该试验旨在表明延迟细胞减灭性肾切除术可改善同步转移性肾细胞癌患者的总生存期，此外，还确定了与个性化肾癌管理相关的生物标志物。
ClinicalTrials.gov NCT03977571 2019 年 6 月 6 日。
