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双联与单药维持治疗非小细胞肺癌的疗效比较:一项荟萃分析。

Doublet vs Single-Agent Maintenance Therapy in the Treatment of Non-Small-Cell Lung Cancer: A Meta-Analysis.

机构信息

Department of Respiration Medicine, Tai'an Central Hospital, Tai'an.

Department of Respiration Medicine, Yankuang Group General Hospital, Jining, China.

出版信息

Drug Des Devel Ther. 2020 Jun 3;14:2179-2185. doi: 10.2147/DDDT.S161542. eCollection 2020.

Abstract

BACKGROUND

Several published meta-analyses have confirmed that single-agent maintenance therapy in advanced non-small-cell lung cancer (NSCLC) can prolong time to disease progression and potentially increase overall survival (OS) in comparison to placebo. However, whether doublet maintenance therapy can improve the survival of advanced NSCLC remains undetermined.

METHODS

We searched several databases for relevant trials. Prospective randomized controlled trials comparing doublet vs single-agent maintenance therapy in NSCLC patients were included for analysis. Outcomes of interest were OS, progression-free survival (PFS), and incidence of grade 3/4 toxicities.

RESULTS

A total of 1,950 advanced-NSCLC patients from six trials were included for analysis. Our results showed that doublet maintenance therapy in NSCLC patients significantly improved PFS (HR 0.74, 95% CI 0.59-0.93; =0.010), but not for OS (HR 0.95, 95% CI 0.85-1.07; =0.40) in comparison with single-agent maintenance therapy. Subgroup analysis by maintenance regimen showed that pemetrexed plus bevacizumab maintenance therapy significantly improved PFS, but not OS. In addition, there was no significant risk difference between doublet and single-agent maintenance therapy in terms of grade 3/4 hematologic and nonhematologic toxicities.

CONCLUSION

Our study suggests that doublet maintenance therapy in advanced-NSCLC patients demonstrates PFS benefits, but not OS benefits, in comparison with single-agent maintenance therapy. Future trials are suggested to assess the long-term clinical benefit of doublet maintenance treatment in NSCLC patients and its impact on health-related quality of life.

摘要

背景

几项已发表的荟萃分析证实,与安慰剂相比,在晚期非小细胞肺癌(NSCLC)中使用单药维持治疗可以延长疾病进展时间,并可能延长总生存期(OS)。然而,双药维持治疗是否能改善晚期 NSCLC 的生存状况仍不确定。

方法

我们在多个数据库中搜索了相关试验。纳入比较 NSCLC 患者双药与单药维持治疗的前瞻性随机对照试验进行分析。主要观察终点为 OS、无进展生存期(PFS)和 3/4 级毒性发生率。

结果

共有来自六项试验的 1950 名晚期 NSCLC 患者纳入分析。结果表明,与单药维持治疗相比,双药维持治疗可显著改善 NSCLC 患者的 PFS(HR 0.74,95%CI 0.59-0.93;=0.010),但对 OS 无显著影响(HR 0.95,95%CI 0.85-1.07;=0.40)。维持方案的亚组分析显示,培美曲塞联合贝伐珠单抗维持治疗可显著改善 PFS,但对 OS 无影响。此外,双药与单药维持治疗在 3/4 级血液学和非血液学毒性方面的风险差异无统计学意义。

结论

本研究表明,与单药维持治疗相比,双药维持治疗可使晚期 NSCLC 患者获益于 PFS,但对 OS 无获益。未来的试验应评估双药维持治疗在 NSCLC 患者中的长期临床获益及其对健康相关生活质量的影响。

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