Department of Urology, Kobe University Graduate School of Medicine, Kobe, Japan;
Department of Urology, Kobe University Graduate School of Medicine, Kobe, Japan.
Anticancer Res. 2023 Feb;43(2):841-847. doi: 10.21873/anticanres.16226.
BACKGROUND/AIM: Increasing availability of effective treatment options for metastatic renal cell carcinoma (mRCC) has highlighted the importance of identifying predictors of treatment response. Although PD-L1 expression in renal cancer has been reported as a predictor of treatment response and prognosis, its assessment by immunohistochemistry is invasive and difficult to perform repeatedly. Soluble PD-L1 (sPD-L1) has recently been proposed as a predictive biomarker for several tumour types. Therefore, we evaluated sPD-L1 levels in patients with mRCC treated with nivolumab and investigated its association with treatment response.
We performed a prospective single-arm study in patients with mRCC treated with nivolumab as second line or later therapy. We measured serum sPD-L1 before and during treatment, classified patients based on baseline values (sPDL1 ≥0.23 ng/ml vs. <0.23 ng/ml) and compared outcomes between the two groups.
A total of 43 patients with mRCC were included in this study, with 17 (39.5%) classified as low sPD-L1 and 26 (60.5%) as high sPD-L1. The International Metastatic RCC Database Consortium risk score was significantly poorer in the high sPD-L1 group. The objective response rate was significantly higher (41.2% vs. 7.7%) and overall survival significantly longer (p=0.0323) in the low group compared to the high group. There were no significant differences in progression-free survival between the two groups.
Our study findings indicate that sPD-L1 might be a predictor of treatment response to nivolumab in patients with mRCC.
背景/目的：越来越多的转移性肾细胞癌（mRCC）有效治疗选择的出现凸显了识别治疗反应预测因素的重要性。尽管肾癌细胞中的 PD-L1 表达已被报道为治疗反应和预后的预测因子，但通过免疫组织化学进行评估具有侵袭性且难以重复进行。可溶性 PD-L1（sPD-L1）最近已被提出作为几种肿瘤类型的预测生物标志物。因此，我们评估了接受nivolumab 治疗的 mRCC 患者的 sPD-L1 水平，并研究了其与治疗反应的关联。
我们对接受 nivolumab 二线或以上治疗的 mRCC 患者进行了一项前瞻性单臂研究。我们在治疗前和治疗期间测量了血清 sPD-L1，根据基线值（sPDL1≥0.23ng/ml 与<0.23ng/ml）对患者进行分类，并比较了两组的结果。
这项研究共纳入了 43 例 mRCC 患者，其中 17 例（39.5%）为低 sPD-L1 组，26 例（60.5%）为高 sPD-L1 组。高 sPD-L1 组的国际转移性肾细胞癌数据库联盟风险评分显著较差。低 sPD-L1 组的客观缓解率显著更高（41.2% 与 7.7%），总生存期显著更长（p=0.0323）。两组之间的无进展生存期无显著差异。
我们的研究结果表明，sPD-L1 可能是 mRCC 患者对 nivolumab 治疗反应的预测因子。
