PD-1/PD-L1 抑制剂联合化疗对比化疗一线治疗晚期非小细胞肺癌疗效及安全性的Meta分析

目的：系统评价PD-1/PD-L1 抑制剂联合化疗对比化疗一线治疗晚期非小细胞肺癌（non-small lung cancer，NSCLC）的疗效及安全性。方法：检索PubMed、Cochrane Library、EMbase、EBSCO循证医学数据库、中国生物医学文献数据库（Chinese Biomedical Literature Database，CBM）、中国知网（Chinese Journal Full-text Database，CNKI）、中文科技期刊全文数据库（VIP）中收录的PD-1/PD-L1 抑制剂联合化疗对比化疗一线治疗晚期NSCLC 的随机对照试验（randomized controlled trials，RCTs），采用RevMan 5.2 软件进行Meta 分析。结果：纳入6 个临床RCTs 共3 238 例晚期NSCLC。Meta 分析结果显示，PD-1/PD-L1 抑制剂联合化疗与化疗相比可显著延长OS（HR=0.86，95%CI=0.79~0.94，P=0.0006）和PFS（HR=0.81，95%CI=0.78~0.84，P<0.00001）；1~5 级血小板计数减少、呕吐、腹泻、甲状腺功能减低或亢进、皮疹、肺炎、结肠炎、肝炎、味觉障碍，3~5 级肝炎的不良反应发生率较化疗组高，差异具有统计学意义（P<0.01 或P<0.05）。结论：PD-1/PD-L1 抑制剂联合化疗较单独化疗一线治疗晚期NSCLC可显著延长患者OS和PFS，但不良反应发生率较化疗高。

Comparison in treatment efficacy and safety between PD-1/PD-L1 inhibitor combined with chemotherapy and chemotherapy alone as first-line treatment for advanced NSCLC: A Meta-analysis

Objective: To systematically evaluate the efficacy and safety of PD-1/PD-L1 inhibitor combined with chemotherapy as comparing with chemotherapy alone for the first-line treatment of advanced NSCLC (non-small lung cancer). Methods: RCTs (randomized controlled trials) on PD-1/PD-L1 inhibitor combined with chemotherapy compared with chemotherapy alone for the first-line treatment of advanced NSCLC were searched in the PubMed, Cochrane Library, EMbase, EBSCO, Chinese Biomedical Literature Database (CBM), Chinese Journal Full-text Database (CNKI), and Chinese Scientific Journal Full-text Database (VIP). RevMan 5.2 software was used for the Meta-analysis. Results: Six RCTs with 3 238 advanced NSCLC patients were included in this study. Meta-analysis showed that the combination therapy group was more effective than the chemotherapy alone group in OS (HR=0.86, 95%CI=0.79~ 0.94, P=0.0006) and PFS (HR=0.81, 95%CI=0.78~0.84, P<0.00001). The incidence of adverse reactions, such as thrombocytopenia of grade 1-5, vomiting, diarrhea, hypothyroidism, hyperthyroidism, rash, pneumonitis, colitis, hepatitis, dysgeusia, hepatitis of grade 3-5 and colitis, in combined treatment group were all higher than those in chemotherapy alone group, the differences were statistically significant (P<0.01 or P<0.05). Conclusions: Compared with chemotherapy alone, PD-1/PD-L1 inhibitor combined with chemotherapy can significantly improve the OS and PFS of patients with advanced NSCLC in the first-line treatment, while the overall incidence of adverse reactions is higher than chemotherapy.