Roviello Giandomenico, Corona Silvia Paola, Nesi Gabriella, Mini Enrico
Department of Health Sciences, University of Florence, viale Pieraccini, 6, 50139, Italy.
Department of Medical, Surgical and Health Sciences, University of Trieste, Italy.
Ther Adv Med Oncol. 2019 Aug 5;11:1758835919861905. doi: 10.1177/1758835919861905. eCollection 2019.
The aim of this study was to perform a literature-based meta-analysis to assess the efficacy of the novel immune checkpoint inhibitors (ICIs) in first-line metastatic renal cell carcinoma (RCC), focusing on the predictive role of PD-L1 expression.
The primary outcome was overall survival, and secondary outcomes were progression-free survival (PFS) and objective response. We planned a subgroup analysis for overall survival according to PD-L1 status.
Five studies were included in the analysis for a total of 4063 cases. Overall survival was greater in PD-L1 positive tumours (HR = 0.49, 95% CI: 0.36-0.67; < 0.001). The pooled analysis of the unselected cases showed a statistically significative improvement in PFS with the use of ICIs (HR = 0.85, 95% CI: 0.72-0.99; = 0.04) and we found a greater PFS benefit (HR = 0.65, 95% CI: 0.57-0.74; < 0.001) in patients with PD-L1 positive tumours.
This study supports the efficacy of ICIs and, although a significant clinical benefit has been reported in PD-L1 negative patients, a greater efficacy of ICIs was observed in PD-L1 positive patients. More prospective randomized studies are needed to clarify the role of PDL-1 status in metastatic RCC treated with ICIs.
本研究旨在进行一项基于文献的荟萃分析,以评估新型免疫检查点抑制剂(ICI)在一线转移性肾细胞癌(RCC)中的疗效,重点关注PD-L1表达的预测作用。
主要结局为总生存期,次要结局为无进展生存期(PFS)和客观缓解率。我们计划根据PD-L1状态对总生存期进行亚组分析。
分析纳入了5项研究,共4063例病例。PD-L1阳性肿瘤的总生存期更长(HR = 0.49,95% CI:0.36 - 0.67;P < 0.001)。对未选择病例的汇总分析显示,使用ICI可使PFS有统计学意义的改善(HR = 0.85,95% CI:0.72 - 0.99;P = 0.04),并且我们发现PD-L1阳性肿瘤患者的PFS获益更大(HR = 0.65,95% CI:0.57 - 0.74;P < 0.001)。
本研究支持ICI的疗效,尽管在PD-L1阴性患者中也报告了显著的临床获益,但在PD-L1阳性患者中观察到ICI的疗效更佳。需要更多前瞻性随机研究来阐明PDL-1状态在接受ICI治疗的转移性RCC中的作用。