免疫检查点抑制剂在复发性或转移性头颈部鳞状细胞癌中的疗效和安全性：一项随机临床试验的系统评价和荟萃分析。

Efficacy and safety of immune checkpoint inhibitors in recurrent or metastatic head and neck squamous cell carcinoma: A systematic review and meta-analysis of randomized clinical trials.

机构信息

Cancer Center, Beijing Tongren Hospital, Capital Medical University, Beijing, China.

出版信息

Cancer Med. 2023 Oct;12(20):20277-20286. doi: 10.1002/cam4.6564. Epub 2023 Oct 10.

BACKGROUND

Immune checkpoint inhibitors (ICIs) showed antitumor activity for recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). However, the results from different studies were controversial.

METHODS

Online databases were searched for randomized clinical trials (RCTs) evaluating ICIs for R/M HNSCC. The characteristics of the studies and the results of overall survival (OS), progression-free survival (PFS), objective response rate (ORR), treatment-related adverse events (TRAEs) were extracted.

RESULTS

A total of 4936 patients from eight studies were included. Anti-PD1/PDL1 monotherapy significantly improved OS in total population (hazard ratio, HR, 0.87, 95% CI, 0.79-0.95, p = 0.003) and PD-L1 high expression patients (HR, 0.71, 95% CI, 0.55-0.90, p = 0.006) with significant lower incidence of any grade TRAEs (odds ratio, OR, 0.16, 95% CI, 0.07-0.37, p < 0.00001) and Grades 3-5 TRAEs (OR, 0.18, 95% CI, 0.10-0.33, p < 0.0001) compared with standard of care (SOC); however, the pooled results of PFS and ORR were not significant different. PD1/PDL1 inhibitors plus CTLA4 inhibitors did not improve OS, PFS, ORR compared with SOC or ICIs monotherapy; however, the incidence of Grades 3-5 TRAEs was significant higher compared with ICIs monotherapy (OR, 1.80, 95% CI, 1.34-2.41, p = 0.0001).

CONCLUSIONS

Anti-PD1/PDL1 monotherapy could improve OS for R/M HNSCC with significant lower incidence of TRAEs compared with SOC. PD1/PDL1 inhibitors plus CTLA4 inhibitors showed no more benefit compared with both SOC and ICIs monotherapy, but the incidence of Grades 3-5 TRAEs was significant higher compared with ICIs monotherapy.

背景

免疫检查点抑制剂（ICIs）在复发性或转移性头颈部鳞状细胞癌（R/M HNSCC）中显示出抗肿瘤活性。然而，不同研究的结果存在争议。

方法

在线数据库中搜索了评估 R/M HNSCC 中 ICIs 的随机临床试验（RCTs）。提取研究的特征以及总生存期（OS）、无进展生存期（PFS）、客观缓解率（ORR）、治疗相关不良事件（TRAEs）的结果。

结果

共有来自八项研究的 4936 名患者被纳入。抗 PD1/PDL1 单药治疗在总人群中显著改善了 OS（风险比 HR，0.87，95%置信区间 0.79-0.95，p=0.003）和 PD-L1 高表达患者（HR，0.71，95%置信区间 0.55-0.90，p=0.006），TRAEs 任何等级（比值比 OR，0.16，95%置信区间 0.07-0.37，p<0.00001）和 3-5 级 TRAEs（OR，0.18，95%置信区间 0.10-0.33，p<0.0001）的发生率显著降低与标准治疗（SOC）相比；然而，PFS 和 ORR 的汇总结果没有显著差异。PD1/PDL1 抑制剂联合 CTLA4 抑制剂与 SOC 或 ICIs 单药治疗相比，并未改善 OS、PFS、ORR；然而，与 ICIs 单药治疗相比，3-5 级 TRAEs 的发生率显著升高（OR，1.80，95%置信区间 1.34-2.41，p=0.0001）。