Department of Urology, University Hospital Tuebingen, Eberhard-Karls-University Tuebingen, Hoppe-Seyler Street 3, 72076, Tuebingen, Germany.
J Cancer Res Clin Oncol. 2023 Jul;149(7):3249-3258. doi: 10.1007/s00432-022-04173-0. Epub 2022 Jul 30.
Immune-based (IO)-combinations are the backbone in the systemic therapy of metastatic renal cell carcinoma (mRCC). Despite phase III clinical trial data, real world data are of special importance to reflect clinical practice.
This retrospective study included 201 mRCC patients receiving first-line systemic therapy from January 2006. Clinicopathological and treatment-related data were recorded. Progression-free (PFS) and overall survival (OS) were analyzed using descriptive statistics and Kaplan-Meier analysis.
Over the years, IO-based therapies have increased significantly. The collective comprises 76 patients with first-line IO-based therapy (IO-IO:55, TKI-IO:21) and 125 patients with TKI-monotherapy. PFS was significantly improved with TKI-IO combinations if compared to both TKI-monotherapy (23.9 vs. 10.3 months, HR 0.48, p = 0.034) and IO-IO combination (23.9 vs. 6.1 months, HR 0.37, p = 0.012). OS for TKI-IO treated patients was longer compared to TKI-monotherapy (HR 0.37, p = 0.050) at median follow-up of 24.1 versus 29.9 months. In a subanalysis of nivolumab treated patients, starting from second-line (n = 40), PFS was 5.5 months. The addition of nivolumab either in second-or later lines improved OS compared to repeated TKI- or mTOR-therapies alone (6.13 vs. 2.61 years, HR 0.46, p = 0.003).
Both first-line IO-based combinations and nivolumab after first-line TKI-monotherapy prolong OS in a real-world setting.
免疫治疗（IO）联合治疗是转移性肾细胞癌（mRCC）系统治疗的基础。尽管有 III 期临床试验数据，但真实世界的数据对于反映临床实践尤为重要。
本回顾性研究纳入了 201 例自 2006 年 1 月起接受一线系统治疗的 mRCC 患者。记录了临床病理和治疗相关数据。采用描述性统计和 Kaplan-Meier 分析评估无进展生存期（PFS）和总生存期（OS）。
多年来，IO 为基础的治疗方法显著增加。其中包含 76 例一线 IO 联合治疗患者（IO-IO：55 例，TKI-IO：21 例）和 125 例 TKI 单药治疗患者。与 TKI 单药治疗相比，TKI-IO 联合治疗的 PFS 显著改善（23.9 个月比 10.3 个月，HR 0.48，p=0.034）和 IO-IO 联合治疗（23.9 个月比 6.1 个月，HR 0.37，p=0.012）。TKI-IO 治疗患者的 OS 较 TKI 单药治疗更长（HR 0.37，p=0.050），中位随访时间为 24.1 个月和 29.9 个月。在纳武单抗二线治疗患者的亚分析中（n=40），PFS 为 5.5 个月。纳武单抗二线或以上治疗的加入，与重复 TKI 或 mTOR 治疗相比，OS 得到改善（6.13 年比 2.61 年，HR 0.46，p=0.003）。
在真实世界环境中，一线 IO 联合治疗和一线 TKI 单药治疗后应用纳武单抗均能延长 OS。
