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PD-1/PD-L1 抑制剂在复发性或转移性鼻咽癌患者中的疗效和安全性:系统评价和荟萃分析。

The efficacy and safety of PD-1/PD-L1 inhibitors in patients with recurrent or metastatic nasopharyngeal carcinoma: A systematic review and meta-analysis.

机构信息

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.

出版信息

Oral Oncol. 2020 May;104:104640. doi: 10.1016/j.oraloncology.2020.104640. Epub 2020 Mar 14.

DOI:10.1016/j.oraloncology.2020.104640
PMID:32182550
Abstract

OBJECTIVES

There is currently no effective salvage therapeutic modality that improves the survival outcomes of patients with recurrent or metastatic nasopharyngeal carcinoma. However, the programmed cell death protein 1 (PD-1) and its ligand (PD-L1) inhibitors may provide clinical benefit for these advanced patients.

MATERIALS AND METHODS

The databases, including PubMed, Web of Science, EMBASE and Cochrane Library, were systematically searched up to Nov 5, 2019. Data of objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) rate, overall survival (OS) rate, and drug-related adverse events were extracted and pooled meta-analyzed.

RESULTS

From 71 search records, eight studies were included in the systematic review, of which three were eligible for final meta-analysis. In recurrent or metastatic nasopharyngeal carcinoma patients treated with anti-PD-1 therapy, the pooled ORR was 27% (95% confidence interval [CI] 19-36%), DCR was 63% (95% CI 50-75%), 6 months PFS rate was 49% (95% CI 40-58%), 1-year PFS rate was 25% (95% CI 19-32%), 1-year OS rate was 61% (95% CI 49-72%). The pooled incidences of any grade and grade ≥ 3 drug-related adverse events were 94% and 20% respectively.

CONCLUSION

We present the aggregate response rates, survival rates and incidences of drug-related adverse events for recurrent or metastatic nasopharyngeal carcinoma patients receiving PD-1/PD-L1 blockage treatment, which could provide useful information for future design of clinical studies. There is a need for more randomized controlled studies with head-to-head comparison of PD-1/PD-L1 inhibitors and traditional chemotherapeutic strategies to enable better recommendations for optimal advanced nasopharyngeal carcinoma treatment.

摘要

目的

目前尚无有效的挽救性治疗方法能改善复发性或转移性鼻咽癌患者的生存结局。然而,程序性死亡蛋白 1(PD-1)及其配体(PD-L1)抑制剂可能为这些晚期患者带来临床获益。

材料和方法

系统检索了包括 PubMed、Web of Science、EMBASE 和 Cochrane Library 在内的数据库,检索时间截至 2019 年 11 月 5 日。提取并汇总分析客观缓解率(ORR)、疾病控制率(DCR)、无进展生存期(PFS)率、总生存期(OS)率和药物相关不良反应的数据。

结果

从 71 条检索记录中,有 8 项研究纳入系统评价,其中 3 项研究符合最终的荟萃分析纳入标准。在接受抗 PD-1 治疗的复发性或转移性鼻咽癌患者中,汇总的 ORR 为 27%(95%CI 19-36%),DCR 为 63%(95%CI 50-75%),6 个月 PFS 率为 49%(95%CI 40-58%),1 年 PFS 率为 25%(95%CI 19-32%),1 年 OS 率为 61%(95%CI 49-72%)。任何级别和≥3 级药物相关不良反应的发生率分别为 94%和 20%。

结论

我们总结了接受 PD-1/PD-L1 阻断治疗的复发性或转移性鼻咽癌患者的总缓解率、生存率和药物相关不良反应发生率,可为未来的临床研究设计提供有用信息。需要更多的随机对照研究,对头对头比较 PD-1/PD-L1 抑制剂和传统化疗策略,以更好地为最佳晚期鼻咽癌治疗提供建议。

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