PD-1/PD-L1抑制剂对接受手术、放疗或化疗后晚期食管癌患者的疗效和安全性的Meta分析

Meta Analysis of the Efficacy and Safety of PD-1/PD-L1 Inhibitors in Patients with Advanced Esophageal Cancer after Surgery, Radiotherapy, or Chemotherapy

摘要: 目的：系统评价PD-1/PD-L1抑制剂对接受手术、放疗或化疗后食管癌患者的疗效和安全性。方法：计算机对PubMed、EMbase、Web of Science、The Cochrane Library、Clinical Trials等多个数据库进行了搜索与筛选工作，以寻找关于手术、放疗或化疗后晚期食管癌患者免疫治疗的相关研究(2018年1月~2022年12月)，应用RevMan5.3软件进行Meta分析。纳入标准为临床II期或III期的双盲随机对照试验(Randomized controlled trials, RCTs)。结果：共纳入9项研究，共5558例晚期食管癌患者。通过数据分析研究发现，免疫抑制剂组和对照组12个月的总体生存率(overall survival, OS) (OR = 1.32, 95% CI: 1.00~1.73, P ≤ 0.05；异质性：I² = 76%，P < 0.01)、无进展生存期(progression-free survival, PFS) (OR = 1.62, 95% CI: 1.15~2.28, P < 0.01；异质性：I² = 76%，P < 0.01)、客观缓解率(objective response rate, ORR) (RR = 1.98, 95% CI: 1.69~2.32, P < 0.01；异质性：I² = 18%，P = 0.28)和毒副反应发生率(OR = 0.36, 95% CI: 0.24~0.54, P < 0.01；异质性：I² = 91%，P < 0.01)具有统计学意义。结论：应用PD-1/PD-L1抑制剂对接受手术、放化疗的晚期食管癌患者能有效提高食管癌患者的总体生存水平，且安全性高。

Abstract: Object: Systematically evaluate the efficacy and safety of PD-1/PD-L1 inhibitors in patients with esophageal cancer after surgery, radiotherapy, or chemotherapy. Method: The computer searched and screened multiple databases such as PubMed, EMbase, Web of Science, The Cochrane Library, Clinical Trials, etc. to search for relevant research on immunotherapy for advanced esophageal can-cer patients after surgery, radiotherapy, or chemotherapy (January 2018 to December 2022), ap-plying RevMan5.3 software for meta-analysis. The inclusion criteria were double blind randomized controlled trials for clinical phase II or III (Randomized controlled trials, RCTs). Results: A total of 9 studies were included, with a total of 5558 patients with advanced esophageal cancer. Through data analysis, it was found that the overall survival rates of the immunosuppressive group and the con-trol group at 12 months (overall survival, OS) (OR = 1.32, 95% CI: 1.00~1.73, P ≤ 0.05; heterogene-ity: I² = 76%, P < 0.01), progression-free survival (OR = 1.62, 95% CI: 1.15~2.28, P < 0.01; hetero-geneity: I² = 76%, P < 0.01), objective response rate (RR = 1.98, 95% CI: 1.69~2.32, P < 0.01; het-erogeneity: I² = 18%, P = 0.28) and the incidence of toxic side effects (OR = 0.36, 95% CI: 0.24~0.54, P < 0.01; heterogeneity: I² = 91%, P < 0.01) have statistically significant. Conclusion: The applica-tion of PD-1/PD-L1 inhibitors can effectively improve the overall survival level of advanced esopha-geal cancer patients undergoing surgery, radiotherapy, and chemotherapy, with high safety.