抗 PD-1/PD-L1 单药治疗与复发性或转移性头颈部鳞状细胞癌患者标准治疗的比较：一项随机对照试验的荟萃分析。
Anti-PD1/PD-L1 monotherapy vs standard of care in patients with recurrent or metastatic head and neck squamous cell carcinoma: A meta-analysis of randomized controlled trials.
机构信息
Central Laboratory, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, China.
出版信息
Medicine (Baltimore). 2021 Jan 29;100(4):e24339. doi: 10.1097/MD.0000000000024339.
BACKGROUND
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.
METHOD
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.
RESULTS
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.
CONCLUSION
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.
背景
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。
方法
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。
结果
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。
结论
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。
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