Central Laboratory, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, China.
Medicine (Baltimore). 2021 Jan 29;100(4):e24339. doi: 10.1097/MD.0000000000024339.
In recent years, a number of clinical trials for antibody drugs targeting programmed cell death protein 1 (PD1)/programmed cell death 1 ligand 1 (PD-L1) have been carried out on recurrent or metastatic head and neck squamous cell carcinoma (R/M SCCHN) and reported promising prospects. To further evaluate and understand the effects and risk of anti-PD1/PD-L1 monotherapy vs standard of care (SoC) in R/M SCCHN, we conducted this meta-analysis of published randomized controlled trials.
The potential eligible trials were searched from Cochrane library and Pubmed and Embase databases. Randomized controlled trials evaluating the effects and risk of anti-PD1/PD-L1 monotherapy vs SoC in platinum refractory R/M SCCHN were selected. The outcomes, including objective response rate, disease control rate, progression-free survival, overall survival, and treatment-related adverse events, were extracted and pooled.
1345 patients with R/M SCCHN from three randomized controlled trials were enrolled in this analysis. Compared with SoC, anti-PD1/PD-L1 monotherapy could provide statistically significant overall survival benefit, hazard ratio (95% confidence interval ) = 0.79 [0.70-0.90]. However, we observed no significant difference between 2 treatments in progression-free survival (hazard ratio [95% confidence interval] = 0.96 [0.85-1.09]). Furthermore, anti-PD1/PD-L1 monotherapy caused less treatment-related adverse events than standard of care.
Anti-PD1/PD-L1 monotherapy could indeed reduce the risk of death in R/M SCCHN patients, and provide higher safety vs SoC. Expression level of PD-L1 may be a useful biomarker for selecting patients with better response to anti-PD1/PD-L1 monotherapy.
近年来，针对复发性或转移性头颈部鳞状细胞癌（R/M SCCHN）的程序性细胞死亡蛋白 1（PD1）/程序性细胞死亡配体 1（PD-L1）抗体药物的临床试验不断开展，并取得了有前景的结果。为了进一步评估和了解抗 PD1/PD-L1 单药治疗与标准治疗（SoC）在 R/M SCCHN 中的疗效和风险，我们对已发表的随机对照试验进行了这项荟萃分析。
从 Cochrane 图书馆和 Pubmed、Embase 数据库中检索可能的合格试验。选择评估抗 PD1/PD-L1 单药治疗与铂类难治性 R/M SCCHN 中 SoC 的疗效和风险的随机对照试验。提取并汇总了客观缓解率、疾病控制率、无进展生存期、总生存期和治疗相关不良事件等结局。
本分析纳入了三项随机对照试验中的 1345 例 R/M SCCHN 患者。与 SoC 相比，抗 PD1/PD-L1 单药治疗可提供具有统计学意义的总生存期获益，风险比（95%置信区间）=0.79 [0.70-0.90]。然而，我们观察到两种治疗方法在无进展生存期方面无显著差异（风险比[95%置信区间] = 0.96 [0.85-1.09]）。此外，抗 PD1/PD-L1 单药治疗比标准治疗导致的治疗相关不良事件更少。
抗 PD1/PD-L1 单药治疗确实可以降低 R/M SCCHN 患者的死亡风险，并与 SoC 相比提供更高的安全性。PD-L1 的表达水平可能是预测对抗 PD1/PD-L1 单药治疗反应更好的患者的有用生物标志物。
