一线免疫联合治疗转移性肾细胞癌患者的真实世界短期疗效及治疗方案比较

Real-world short-term outcomes and treatment regimen comparisons in patients with metastatic renal cell carcinoma treated with first-line immune combinations.

作者信息

Kikuta Masato, Naito Sei, Osawa Takahiro, Numakura Kazuyuki, Narisawa Takafumi, Takai Yuki, Yagi Mayu, Sekine Yuya, Tokairin Ojiro, Shinohara Nobuo, Habuchi Tomonori, Tsuchiya Norihiko

机构信息

Department of Urology, Yamagata University School of Medicine, Iida-Nishi 2-2-2, Yamagata, 990-9585, Japan.

Department of Renal and Genitourinary Surgery, Graduate School of Medicine, Hokkaido University, Sapporo, Japan.

出版信息

BMC Cancer. 2025 Jan 22;25(1):117. doi: 10.1186/s12885-025-13504-6.

BACKGROUND

Immune-combinations have recently become the standard first-line treatment for patients with metastatic renal cell carcinoma (mRCC). This study evaluated the applicability of the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk model in predicting outcomes for patients treated with either immune-oncologic drug doublet (IO-IO) or immune-oncologic drug tyrosine kinase inhibitor combinations (IO-TKI). A secondary objective to compare the effectiveness of IO-IO versus IO-TKI within the IMDC risk groups over a short follow-up period.

METHODS

A retrospective analysis was conducted on 172 patients with mRCC treated with first-line immunotherapy combinations. Progression free survival (PFS), time to treatment failure 2 (TTF2), and overall survival (OS) were compared between IMDC risk categories. Model fit was assessed using the c-index. The inverse probability of treatment weighting (IPTW) method was used to adjust and compare outcomes between IO-IO and IO-TKI, except for IMDC favorable risk patients due to the small number of IO-IO cases.

RESULTS

The IMDC risk model demonstrated a c-index of 0.684 (OS) for entire cohort, 0.600 (PFS), 0.596 (TTF2), and 0.624 (OS) for IO-IO, and 0.667 (PFS), 0.702 (TTF2), and 0.751 (OS) for IO-TKI. In the IMDC intermediate and poor risk groups after IPTW adjustment, PFS (HR 0.72), TTF2 (HR 0.67), and OS (HR 0.74) did not significantly differ between IO-IO and IO-TKI. Specifically, in the IMDC intermediate risk group, PFS (HR 0.79), TTF2 (HR 0.69), and OS (HR 0.65) were longer in IO-TKI, though the differences were not statistically significant. In the IMDC poor risk group, PFS (HR 0.76), TTF2 (HR 0.77), and OS (HR 1.03) were comparable.

CONCLUSIONS

The impact of IMDC risk model on survival was modest in IO-IO, while remained statistically substantial in IO-TKI. Survival outcomes did not significantly differ between IO-IO and IO-TKI during the short follow-up period.

背景

免疫联合疗法最近已成为转移性肾细胞癌（mRCC）患者的标准一线治疗方法。本研究评估了国际转移性肾细胞癌数据库联盟（IMDC）风险模型在预测接受免疫肿瘤药物双联疗法（IO-IO）或免疫肿瘤药物与酪氨酸激酶抑制剂联合疗法（IO-TKI）治疗的患者预后方面的适用性。第二个目标是在短随访期内比较IMDC风险组中IO-IO与IO-TKI的有效性。

方法

对172例接受一线免疫治疗联合方案的mRCC患者进行回顾性分析。比较了IMDC风险类别之间的无进展生存期（PFS）、治疗失败时间2（TTF2）和总生存期（OS）。使用c指数评估模型拟合度。除IMDC低风险患者外，由于IO-IO病例数量较少，采用治疗权重逆概率（IPTW）方法调整并比较IO-IO和IO-TKI之间的结局。

结果

IMDC风险模型在整个队列中的c指数为0.684（OS），IO-IO为0.600（PFS）、0.596（TTF2）和0.624（OS），IO-TKI为0.667（PFS）、0.702（TTF2）和0.751（OS）。在IPTW调整后的IMDC中危和高危风险组中，IO-IO和IO-TKI之间的PFS（HR 0.72）、TTF2（HR 0.67）和OS（HR 0.74）无显著差异。具体而言，在IMDC中危风险组中，IO-TKI的PFS（HR 0.79）、TTF2（HR 0.69）和OS（HR 0.65）更长，尽管差异无统计学意义。在IMDC高危风险组中，PFS（HR 0.76）、TTF2（HR 0.77）和OS（HR 1.03）相当。