Ishikawa Gaku, Tamura Keita, Tsuchiya Yoshihiro, Watanabe Shunsuke, Ayana Takemura, Asuka Sano, Watanabe Kyohei, Watanabe Hiromitsu, Matsushita Yuto, Motoyama Daisuke, Otsuka Atsushi, Inamoto Teruo
Department of Urology, Hamamatsu University School of Medicine, Hamamatsu, Japan;
Department of Urology, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Anticancer Res. 2025 Jan;45(1):379-386. doi: 10.21873/anticanres.17426.
BACKGROUND/AIM: Immuno-oncology (IO) improves the prognosis of advanced renal cell carcinoma (RCC). Since research has so far been limited to clinical trials, we herein focused on the effects of IO-tyrosine kinase inhibitor (TKI) combination therapy in real-world clinical settings.
We conducted a retrospective study on 125 patients with advanced RCC who received IO-TKI combination therapy or TKI monotherapy. Oncological outcomes were assessed by progression-free survival (PFS) and overall survival (OS), and prognostic factors for PFS and OS were investigated. We then evaluated PFS and OS based on the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC).
The IO-TKI group showed significantly longer median PFS (18.6 months vs. 10.1 months, p=0.008) and OS (not reached vs. 34.2 months, p=0.041) than the TKI group. A multivariate analysis identified the Karnofsky performance risk score, first-line therapy (IO-TKI combination therapy or TKI monotherapy), and high C-reactive protein levels as poor prognostic factors for both PFS and OS. PFS did not significantly differ in IMDC favorable-risk patients between the groups but was significantly longer in IMDC intermediate- and poor-risk patients in the IO-TKI group than in the TKI group. OS did not significantly differ in IMDC favorable- and intermediate-risk patients between the groups but was significantly longer in IMDC poor-risk patients in the IO-TKI group.
We demonstrated the advantage of IO-TKI combination therapy compared to TKI monotherapy in real-world clinical settings. However, in IMDC favorable patients PFS and OS did not significantly differ to TKI monotherapy. This may indicate the need for caution when selecting treatment options for IMDC favorable-risk patients.
背景/目的:免疫肿瘤学(IO)改善了晚期肾细胞癌(RCC)的预后。由于迄今为止的研究仅限于临床试验,我们在此关注IO-酪氨酸激酶抑制剂(TKI)联合治疗在真实世界临床环境中的效果。
我们对125例接受IO-TKI联合治疗或TKI单药治疗的晚期RCC患者进行了一项回顾性研究。通过无进展生存期(PFS)和总生存期(OS)评估肿瘤学结局,并研究PFS和OS的预后因素。然后我们基于国际转移性肾细胞癌数据库联盟(IMDC)评估了PFS和OS。
IO-TKI组的中位PFS(18.6个月对10.1个月,p = 0.008)和OS(未达到对34.2个月,p = 0.041)显著长于TKI组。多变量分析确定卡诺夫斯基表现风险评分、一线治疗(IO-TKI联合治疗或TKI单药治疗)以及高C反应蛋白水平是PFS和OS的不良预后因素。两组间IMDC低危患者的PFS无显著差异,但IO-TKI组IMDC中危和高危患者的PFS显著长于TKI组。两组间IMDC低危和中危患者的OS无显著差异,但IO-TKI组IMDC高危患者的OS显著更长。
我们证明了在真实世界临床环境中IO-TKI联合治疗相比于TKI单药治疗的优势。然而,在IMDC低危患者中,PFS和OS与TKI单药治疗无显著差异。这可能表明在为IMDC低危患者选择治疗方案时需要谨慎。