一线治疗方案在晚期肾细胞癌中的疗效及风险因素影响的真实世界比较

Real-world comparison of the efficacy of first-line therapies and the influence of risk factors in advanced renal cell carcinoma.

作者信息

Haack Maximilian, Neuberger Stephanie, Boerner Jan Hendrik, Ziewers Stefanie, Duwe Gregor, Dotzauer Robert, Haferkamp Axel, Mager Rene

机构信息

Department of Urology and Pediatric Urology, Johannes Gutenberg University Medical Center, Langenbeckstraße 1, 55131, Mainz, Rhineland-Palatinate, Germany.

出版信息

Discov Oncol. 2025 Mar 19;16(1):359. doi: 10.1007/s12672-025-02131-z.

Abstract

INTRODUCTION

Systemic therapy for advanced renal cell carcinoma (aRCC) has become increasingly diverse. In the 1st-line setting, various combination therapies are available, with little comparative data on the efficacy of the therapies. The aim of this study was to compare the current 1st-line combination therapies under real-life conditions and to investigate risk factors in the patient population.

METHODS

Patients with aRCC who started 1st-line IO/IO or IO/TKI combination  therapy between 03/2019 and 10/2023 were included. The primary endpoints were progression-free survival (PFS) and overall survival (OS). Secondary endpoints were time on treatment (ToT), duration of response (DoR), subsequent therapies, the evaluation of risk factors and their influence on PFS and OS. Survival data were analysed using Kaplan-Meier estimates with log-rank tests, risk factors for PFS and OS using Cox regression analysis.

RESULTS

A total of 59 patients, mainly men (79.7%) with a median age of 64.8 years were included. The median follow-up was 21 months. The comparison of IO/IO vs. IO/TKI demonstrated a median PFS of 6 (2.08-9.92) vs. 14 (9.06-18.94) months (47 events; HR IO/TKI vs. IO/IO: 0.53 (0.29-0.99); p = 0.039) and a median OS of 20 (15.07-24.94) vs. 33 (21.68-44.32) months (32 deaths; HR IO/TKI vs. IO/IO: 0.74 (0.36-1.51); p = 0.403). Off all risk factors analysed only synchronous metastases proved to be of independent predictive value for PFS (HR 2.38; 95% CI 1.11-5.11; p = 0.026) and OS (HR 3.47; 95% CI 1.15-10.44; p = 0.027).

CONCLUSION

An IO/TKI therapy showed a significantly improved PFS in the real-world setting compared to an IO/IO combination. In terms of OS, the improved treatment response of the IO/TKI group did not prevail.

摘要

引言

晚期肾细胞癌(aRCC)的全身治疗方法日益多样化。在一线治疗中,有多种联合治疗方案可供选择,但关于这些治疗方案疗效的比较数据较少。本研究的目的是在实际临床环境中比较当前的一线联合治疗方案,并调查患者群体中的危险因素。

方法

纳入2019年3月至2023年10月期间开始接受一线免疫治疗(IO)/IO或IO/酪氨酸激酶抑制剂(TKI)联合治疗的aRCC患者。主要终点为无进展生存期(PFS)和总生存期(OS)。次要终点为治疗时间(ToT)、缓解持续时间(DoR)、后续治疗、危险因素评估及其对PFS和OS的影响。生存数据采用Kaplan-Meier估计法和对数秩检验进行分析,PFS和OS的危险因素采用Cox回归分析。

结果

共纳入59例患者,主要为男性(79.7%),中位年龄64.8岁。中位随访时间为21个月。IO/IO与IO/TKI的比较显示,中位PFS分别为6(2.08 - 9.92)个月和14(9.06 - 18.94)个月(47例事件;IO/TKI与IO/IO相比的风险比(HR):0.53(0.29 - 0.99);p = 0.039),中位OS分别为20(15.07 - 24.94)个月和33(21.68 - 44.32)个月(32例死亡;IO/TKI与IO/IO相比的HR:0.74(0.36 - 1.51);p = 0.403)。在所有分析的危险因素中,只有同时性转移被证明对PFS(HR 2.38;95%置信区间1.11 - 5.11;p = 0.026)和OS(HR 3.47;95%置信区间1.15 - 10.44;p = 0.027)具有独立的预测价值。

结论

在实际临床环境中,与IO/IO联合治疗相比,IO/TKI治疗的PFS有显著改善。在OS方面,IO/TKI组改善的治疗反应并不显著。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4f0/11923313/e6c679916111/12672_2025_2131_Fig1_HTML.jpg

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