Background This pooled analysis of patient-level data from trials evaluated the clinical outcomes of patients with metastatic renal cell carcinoma (mRCC) with or without cytoreductive nephrectomy (CN) prior to a combination of immune checkpoint inhibitor (ICI) and anti-angiogenic therapy. Methods Five trials of ICI plus anti-angiogenic therapy were pooled. Only patients with stage 4 at initial diagnosis were included to ensure that nephrectomy was done for cytoreductive purposes and not to previously treat an earlier stage of disease. Effect of CN prior to ICI on outcomes was evaluated using the Kaplan-Meier method and a Cox proportional hazards regression model, adjusted for age, sex, risk group, performance status, and presence of sarcomatoid differentiation. Results A total of 981 patients were included. The estimated median progression-free survival with and without nephrectomy was 15 and 11 months, respectively, and the adjusted hazard ratio (HR) was 0.71 (95% CI: 0.59 to 0.85). The estimated median overall survival with and without nephrectomy was 46 and 28 months, respectively, and the adjusted HR was 0.63 (95% CI: 0.51 to 0.77). Objective response was 60% of patients with vs 46% of patients without CN. Conclusions Patients with mRCC with CN prior to ICI plus anti-angiogenic therapy had improved outcomes compared to patients without CN. Selection factors for CN may be prognostic and could not be fully controlled for in this retrospective analysis. Prospective determination of and stratification by prior CN may be considered when designing clinical trials to assess impact of this factor on prognosis.

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免疫检查点抑制剂时代的减瘤肾切除术：美国 FDA 汇总分析

背景 这项对来自试验的患者水平数据的汇总分析评估了在免疫检查点抑制剂 (ICI) 和抗血管生成联合治疗之前接受或不接受肿瘤细胞减灭术 (CN) 的转移性肾细胞癌 (mRCC) 患者的临床结果。方法 汇总了五项 ICI 加抗血管生成治疗的试验。仅纳入初次诊断时处于 4 期的患者，以确保进行肾切除术是为了细胞减灭术，而不是为了预先治疗疾病的早期阶段。使用 Kaplan-Meier 方法和 Cox 比例风险回归模型评估 ICI 之前 CN 对结果的影响，并根据年龄、性别、风险组、体能状态和肉瘤样分化的存在进行调整。结果共纳入981例患者。接受或不接受肾切除术的估计中位无进展生存期分别为 15 个月和 11 个月，调整后的风险比 (HR) 为 0.71（95% CI：0.59 至 0.85）。有和没有肾切除术的估计中位总生存期分别为 46 个月和 28 个月，调整后的 HR 为 0.63（95% CI：0.51 至 0.77）。患有 CN 的患者的客观缓解率为 60%，而无 CN 的患者的客观缓解率为 46%。结论 与无 CN 的患者相比，在 ICI 联合抗血管生成治疗之前患有 CN 的 mRCC 患者的预后有所改善。CN 的选择因素可能具有预后意义，并且在本回顾性分析中无法完全控制。在设计临床试验以评估该因素对预后的影响时，可以考虑根据先前的 CN 进行前瞻性确定和分层。