Introduction: Combinations of immune-checkpoint inhibitors (ICIs) are the standard of care (SOC) for treatment-naive metastatic renal cell carcinoma (mRCC) patients. In this multicenter study, we evaluated the RW safety and efficacy of cabozantinib plus nivolumab in mRCC patients. Methods: Data were retrospectively collected from twelve cancer centers in Germany, Switzerland, and Austria. Patients with advanced or mRCC were eligible. The investigator-based objective response rate (ORR) and progression free survival (PFS) were calculated from the start of the treatment to progression or death. Descriptive statistics and Kaplan–Meier (KM) plots were utilized where appropriate. Results: In total, 96 eligible patients (66.6% male) with a median age of 66.0 years were included. The most common histology was clear-cell RCC (ccRCC) in 63.4% (n= 61). A prior nephrectomy was performed in 60.4% (n= 58). ECOG 0-1 was 68.8% (n= 66). A partial response was documented in 43.8% of patients (n= 42), a stable disease in 32.3% (n= 31), and a progressive disease in 8.3% (n= 8) as the best overall response. Response data were not evaluable in 13.5% (n= 13). The median follow-up time was 12.7 months (95% CI, 10.0–15.3). The PFS rate at 6 months was 89.8% in the overall population (86.8% for ccRCC; 90.0% for non-ccRCC). Adverse events (AEs) were reported in 82.3% (n= 79) for all grades and 41.7% (n= 40) for grades 3–5. Elevated liver enzymes (34.4%), diarrhea (31.3%), and hand–foot syndrome (29.2%) were the three most frequent AEs of any grade and causality. Discussion/Conclusions: In this real-world cohort of mRCC patients, the application of cabozantinib plus nivolumab was shown to be safe and feasible. Our data support the use of cabozantinib plus nivolumab as a first-line standard therapy in mRCC patients. Major limitations were the retrospective data capture and short follow-up time of our study.
引言：免疫检查点抑制剂（ICI）联合疗法是初治转移性肾细胞癌（mRCC）患者的标准治疗方案。本项多中心研究评估了卡博替尼联合纳武利尤单抗在mRCC患者中的真实世界安全性与疗效。方法：回顾性收集德国、瑞士和奥地利12个癌症中心的数据。纳入标准为晚期或转移性肾细胞癌患者。研究者评估的客观缓解率（ORR）和无进展生存期（PFS）从治疗开始计算至疾病进展或死亡。采用描述性统计和Kaplan-Meier生存曲线进行数据分析。结果：共纳入96例符合条件患者（男性占66.6%），中位年龄66.0岁。最常见病理类型为透明细胞肾细胞癌（ccRCC），占63.4%（n=61）。60.4%（n=58）患者曾接受肾切除术。ECOG评分0-1分者占68.8%（n=66）。最佳总体缓解情况：部分缓解43.8%（n=42），疾病稳定32.3%（n=31），疾病进展8.3%（n=8），13.5%（n=13）患者缓解数据无法评估。中位随访时间12.7个月（95%CI：10.0-15.3）。全人群6个月PFS率为89.8%（ccRCC亚组86.8%；非ccRCC亚组90.0%）。82.3%（n=79）患者报告了各级不良事件（AEs），41.7%（n=40）报告3-5级不良事件。最常见不良事件（任意等级与因果关系）为肝酶升高（34.4%）、腹泻（31.3%）和手足综合征（29.2%）。讨论/结论：在这项mRCC真实世界队列研究中，卡博替尼联合纳武利尤单抗方案显示出安全性和可行性。本研究数据支持将该联合方案作为mRCC患者的一线标准治疗。主要局限性在于回顾性数据收集和随访时间较短。
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