Efficacy and Safety of PD-1/PD-L1 Inhibitor Versus Chemotherapy in First-line Treatment of Advanced Non-small Cell Lung Cancer: A Meta-analysis
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摘要:目的
系统评价PD-1/PD-L1抑制剂对比化疗一线治疗晚期非小细胞肺癌的疗效及安全性。
方法通过Web of science等国内外数据库，ASCO会议摘要及杂志筛选文献，进行Meta分析。
结果纳入7项RCT研究，4 101例患者，荟萃分析显示抑制剂联合化疗对比化疗可显著延长患者的PFS（HR=0.59, 95%CI: 0.50~0.70, P < 0.00001）、OS（HR=0.65, 95%CI: 0.46~0.92, P=0.02）及ORR（RR=1.72, 95%CI: 1.13~2.62, P=0.01）。亚组分析显示，抑制剂联合化疗可显著延长PFS及OS，且PD-L1表达程度越高，疗效获益越显著。而单药抑制剂对比化疗在延长晚期NSCLC患者的PFS（HR=0.87, 95%CI: 0.57~1.31, P=0.50）、OS（HR=0.82, 95%CI: 0.65~1.03, P=0.09）及提高ORR（RR=1.12, 95%CI: 0.55~2.28, P=0.76）方面两组差异无统计学意义。与化疗相比，单药抑制剂一线治疗PD-L1高表达的晚期NSCLC患者可显著延长OS，但在延长PFS方面未见明显优势。与化疗组相比，抑制剂联合化疗组3~4级不良反应发生率无明显改善（HR=1.09，95%CI: 0.99~1.20, P=0.09），而单药PD-1/PD-L1抑制剂组3~4级不良反应发生率低（RR=0.43, 95%CI: 0.36~0.52, P < 0.00001）。
结论PD-1/PD-L1抑制剂联合化疗一线治疗晚期NSCLC患者疗效优于化疗方案；PD-L1高表达者单药PD-1/PD-L1抑制剂可作为一线治疗的优先选择，且具有良好的安全性。
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关键词:
- PD-1/PD-L1抑制剂 /
- 化疗 /
- 一线治疗 /
- 晚期非小细胞肺癌 /
- Meta分析
Abstract:ObjectiveTo review the effectiveness and safety of PD-1/PD-L1 inhibitor versus chemotherapy in the first-line treatment of advanced non-small cell lung cancer.
MethodsRelevant literatures were searched through Web of Science database, ASCO meeting abstract, journals, etc. for meta-analysis.
ResultsTotally 7 RCTs including 4101 patients were analyzed. The meta-analysis showed that compared with chemotherapy, PD-1/PD-L1 inhibitor combined with chemotherapy significantly prolonged PFS (HR=0.59, 95%CI: 0.59-0.70, P < 0.00001), OS (HR=0.65, 95%CI: 0.65-0.92, P=0.02) and ORR(RR=1.72, 95%CI: 1.13-2.62, P=0.01). Subgroup analysis showed PD-1/PD-L1 inhibitor combined with chemotherapy could significantly prolong PFS and OS, compared with chemotherapy. The higher PD-L1 expression was, the more significant the curative effect was. There was no statistical significance in prolonging PFS (HR=0.87, 95%CI: 0.57-1.31, P=0.50), OS (HR=0.82, 95%CI: 0.65-1.03, P=0.09) or increasing ORR (RR=1.12, 95%CI: 0.55-2.28, P=0.76) between single-agent PD-1/PD-L1 inhibitor and chemotherapy. Compared with chemotherapy, single-agent PD-1/PD-L1 inhibitor in the first-line treatment could significantly prolong the OS of advanced NSCLC patients with high PD-L1 expression. Grade 3-4 treatment-related adverse effect was not statistically significant different between PD-1/PD-L1 inhibitor combined with chemotherapy group and chemotherapy group (HR=1.09, 95%CI: 0.99-1.20, P=0.09), while that in single-agent PD-1/PD-L1 inhibitor group was lower (RR=0.43, 95%CI: 0.36-0.52, P < 0.00001).
ConclusionCompared with chemotherapy, PD-1/PD-L1 inhibitor combined with chemotherapy in the first-line treatment on advanced NSCLC patients is more effective; single-agent PD-1/PD-L1 inhibitor should be used as the first-line treatment preferentially on advanced NSCLC patient with high PD-L1 expression.
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作者贡献魏 瑜： 文献筛选、数据分析、论文撰写张 莉： 文献筛选、论文指控及审核
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图 3 试验组与对照组相比对无进展生存期(PFS)的Meta分析
Figure 3 Meta-analysis results of PFS between experimental and control group
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图 4 试验组与对照组相比对总生存期(OS)的Meta分析
Figure 4 Meta-analysis results of OS between experimental and control groups
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图 5 试验组与对照组相比对客观有效率(ORR)的Meta分析
Figure 5 Meta-analysis results of ORR between experimental and control groups
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图 6 试验组与对照组相比对3~4级不良反应的Meta分析
Figure 6 Meta-analysis results of grade 3-4 toxicities between experimental and control groups
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图 7 试验组对比对照组总生存期的漏斗图
Figure 7 Begg's funnel plot of OS between experimental and control groups
表 2 PD-1/PD-L1抑制剂联合化疗组和单药PD-1/PD-L1抑制剂组在不同PD-L1表达程度PFS的亚组分析
Table 2 Subgroup analysis of PFS of advanced NSCLC patients with different PD-L1 expression in PD-1/PD-L1 inhibitor combined with chemotherapy group and singleagent PD-1/PD-L1 inhibitor group
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表 3 PD-1/PD-L1抑制剂联合化疗组和单药PD-1/PD-L1抑制剂组在不同PD-L1表达程度总生存期(OS)的亚组分析
Table 3 Subgroup analysis of OS of advanced NSCLC patients with different PD-L1 expression in PD-1/PD-L1 inhibitor combined chemotherapy group and single-agent PD-1/PD-L1 inhibitor group
下载: 导出CSV
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