Santoni Matteo, Aurilio Gaetano, Massari Francesco, Grande Enrique, Matrana Marc R, Rizzo Mimma, De Giorgi Ugo, Incorvaia Lorena, Martignetti Angelo, Molina-Cerrillo Javier, Zabalza Ignacio Ortego, Mollica Veronica, Rizzo Alessandro, Battelli Nicola, Porta Camillo
Oncology Unit, Macerata Hospital, Macerata, Italy.
Medical Oncology Division of Urogenital and Head and Neck Tumours, IEO, European Institute of Oncology IRCCS, Milan, Italy.
Clin Genitourin Cancer. 2022 Jun;20(3):285-295. doi: 10.1016/j.clgc.2022.02.003. Epub 2022 Feb 19.
Tyrosine-kinase inhibitors (TKIs) still represent a first-line option for selected patients with metastatic Renal Cell Carcinoma (mRCC). We aimed to compare the real-world efficacy of nivolumab or cabozantinib as second-line therapy in specific mRCC subpopulations.
We retrospectively collected data from 11 centers from Italy, Spain and US. Overall Survival (OS) and Progression-Free Survival (PFS) were analyzed using Kaplan-Meier curves. Cox proportional models were used at univariate and multivariate analyses.
We collected data from 343 patients with mRCC, 123 (36%) treated with cabozantinib and 220 (64%) with nivolumab. The median OS resulted longer, but not statistically significant, with nivolumab in patients aged >70 years (21.4 vs. 15.4 months, P = .746), treated with first-line pazopanib (26.8 vs. 11.6 months, P = .450), or with good (47.0 vs. 15.5 months, P = .285) or intermediate-risk criteria (14.4 vs. 11.0 months, P = .357), while it was longer, but even not statistically significant, for cabozantinib in patients who received previous sunitinib (25.7 vs. 21.7 months, P = .638) or with bone metastases (28.4 vs. 24.4 months, P = .871). The median PFS was significantly longer with cabozantinib in patients with clear cell histology (7.8 vs. 5.4 months, P = .026) and in patients with good risk features (12.3 vs. 5.7 months, P = .022).
Nivolumab and cabozantinib resulted active in mRCC patients, showing distinct results when stratified into clinico-pathological features.
酪氨酸激酶抑制剂（TKIs）仍是部分转移性肾细胞癌（mRCC）患者的一线治疗选择。我们旨在比较纳武单抗或卡博替尼作为特定mRCC亚群二线治疗的真实疗效。
我们回顾性收集了来自意大利、西班牙和美国11个中心的数据。采用Kaplan-Meier曲线分析总生存期（OS）和无进展生存期（PFS）。单因素和多因素分析使用Cox比例模型。
我们收集了343例mRCC患者的数据，其中123例（36%）接受卡博替尼治疗，220例（64%）接受纳武单抗治疗。在年龄>70岁的患者中，纳武单抗组的中位OS更长，但无统计学意义（21.4个月对15.4个月，P = 0.746）；一线使用帕唑帕尼治疗的患者中，纳武单抗组的中位OS更长，但无统计学意义（26.8个月对11.6个月，P = 0.450）；风险良好（47.0个月对15.5个月，P = 0.285）或中危标准的患者中，纳武单抗组的中位OS更长，但无统计学意义（14.4个月对11.0个月，P = 0.357）。而在接受过舒尼替尼治疗的患者中，卡博替尼组的中位OS更长，但无统计学意义（25.7个月对21.7个月，P = 0.638）；有骨转移的患者中，卡博替尼组的中位OS更长，但无统计学意义（28.4个月对24.4个月，P = 0.871）。在透明细胞组织学的患者中，卡博替尼组的中位PFS显著更长（7.8个月对5.4个月，P = 0.026）；在风险良好的患者中，卡博替尼组的中位PFS显著更长（12.3个月对5.7个月，P = 0.022）。
纳武单抗和卡博替尼在mRCC患者中均有活性，根据临床病理特征分层时显示出不同的结果。
