目的:对于转移性/复发性鼻咽癌(NPC)患者,程序性细胞死亡蛋白1(PD-1)是一个有争议的选择.这项荟萃分析旨在研究PD-1抑制剂在转移性/复发性鼻咽癌患者中的疗效和安全性。方法:电子数据库,如PubMed,Embase,科克伦图书馆,和WebofScience进行手动搜索,直到2022年7月1日,Stata15.0用于分析数据。结果:共纳入10项研究,其中三项是有数据的随机对照试验,七个是单臂研究。对于随机对照试验(RCT)研究,ORR[OR=1.11,95%CI(.49,2.52);p=.812],OS[1年OR=1.26,95%CI(.76,2.08);p=.367],[2年OR=1.04,95%CI(.39,2.71);p=.928]转移性/复发性鼻咽癌患者与PD-1抑制剂治疗和常规化疗一致。然而,PD-1抑制剂的1年PFS高于常规化疗[OR=2.16,95%CI(1.26,3.70);p=.005]。对于单臂研究,PD-1抑制剂治疗后,复发/转移性鼻咽癌患者的ORR达到[ES=37%,95CI(17%-56%)],1年OS[ES=61%,95%CI(46%-76%)],2年[ES=16%,95%CI(6%-26%)],和1年PFS[ES=16%,95%CI(12%-20%)]。结论:PD-1抑制剂单药治疗鼻咽癌转移/复发患者的疗效与常规化疗无明显差异;由于纳入研究的局限性,需要进一步的III期随机对照试验来证实我们的结论.系统审查注册:https://www。crd.约克。AC.uk/prospro/display_record.php?ID=CRD42022342400;标识符:CRD42022342400。
Objective: For metastatic/recurrent nasopharyngeal carcinoma (NPC) patients, a programmed cell death protein 1 (PD-1) is a controversial option. This meta-analysis aimed to investigate the efficacy and safety of PD-1 inhibitors in patients with metastatic/recurrent NPC. Methods: Electronic databases such as PubMed, Embase, Cochrane library, and Web of Science were manually searched until 1 July 2022, and Stata 15.0 was used to analyze the data. Result: A total of 10 studies were included, of which three were randomized controlled trials with data, and seven were single-arm studies. For randomized controlled trial (RCT) study, ORR [OR = 1.11, 95% CI (.49, 2.52); p = .812], OS [1-year OR = 1.26, 95% CI (.76, 2.08); p = .367], [2-year OR = 1.04, 95% CI (.39, 2.71); p = .928] in patients with metastatic/recurrent NPC were consistent with PD-1 inhibitor therapy and conventional chemotherapy. However, PD-1 inhibitor had higher 1-year PFS than conventional chemotherapy [OR = 2.16, 95% CI (1.26, 3.70); p = .005]. For single-arm studies, after PD-1 inhibitor therapy, the ORR of patients with recurrent/metastatic NPC reached [ES = 37%, 95 CI (17%-56%)], 1-year OS [ES = 61%, 95% CI (46%-76%)], 2-year [ES = 16%, 95% CI (6%-26%)], and 1-year PFS [ES = 16%,95% CI (12%-20%)]. Conclusion: The efficacy of PD-1 inhibitor monotherapy in patients with metastatic/recurrent nasopharyngeal carcinoma was not significantly different from that of conventional chemotherapy; however, due to the limitations of the included studies, further phase III RCTs are required to corroborate our conclusion. Systematic
Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022342400; Identifier: CRD42022342400.