Objective

To assess the efficacy and toxicity of anlotinib for the treatment of refractory advanced non-small-cell lung cancer (NSCLC).

Methods

We systematically searched databases for randomized controlled trials on anlotinib treatment for patients with advanced NSCLC published until November 6, 2020. Articles were assessed and data were extracted independently by two investigators. Further, we analyzed hazard ratios (HRs) for progression-free and overall survival (PFS and OS, respectively). In addition, we analyzed risk ratio (RR) for overall response and disease control rates (ORR and DCR, respectively) and the odds ratio (OR) for the main adverse events (AEs) using RevMan 5.3 software.

Results

This analysis included 594 patients from three clinical studies. The pooled HRs for PFS and OS were 0.27 (95% confidence interval (CI): 0.22–0.33, P < 0.001) and 0.68 (95% CI: 0.56–0.83, P < 0.001), respectively, indicating that anlotinib administration significantly improved PFS and OS in patients with advanced NSCLC. The pooled RRs for ORR and DCR were 11.62 (95% CI: 2.75–49.14, P < 0.001) and 2.30 (95% CI: 1.91–2.77, P < 0.001), respectively, indicating that anlotinib administration in patients with advanced NSCLC improved ORR and DCR. The pooled OR for AEs of grade 3 or higher was 2.94 (95% CI: 1.99–4.35, P < 0.001), indicating that AEs of grade 3 or higher were more prevalent in the anlotinib group than in the placebo group.

Conclusion

Anlotinib, an effective choice of third- or later line therapy for patients with refractory advanced NSCLC, provides clinical benefits in terms of PFS, OS, ORR, and DCR. AEs associated with anlotinib were tolerable.

中文翻译：

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安洛替尼治疗难治性晚期非小细胞肺癌的系统评价和荟萃分析

目的

评估安洛替尼治疗难治性晚期非小细胞肺癌（NSCLC）的疗效和毒性。

方法

我们系统地搜索了数据库，以研究在2020年11月6日之前发布的晚期NSCLC患者接受anlotinib治疗的随机对照试验。文章由两名研究人员独立评估和提取数据。此外，我们分析了无进展生存期和总生存期（分别为PFS和OS）的危险比（HRs）。此外，我们使用RevMan 5.3软件分析了总体响应和疾病控制率（分别为ORR和DCR）的风险比（RR）和主要不良事件（AE）的优势比（OR）。

结果

该分析包括来自三项临床研究的594例患者。PFS和OS的合并HR分别为0.27（95％置信区间（CI）：0.22-0.33，P <0.001）和0.68（95％CI：0.56-0.83，P <0.001），表明安洛替尼给药明显改善晚期NSCLC患者的PFS和OS。ORR和DCR的合并RRs分别为11.62（95％CI：2.75–49.14，P <0.001）和2.30（95％CI：1.91–2.77，P <0.001），表明晚期NSCLC患者服用anlotinib改善了ORR和DCR。3级或更高级别AE的合并OR为2.94（95％CI：1.99–4.35，P <0.001），表明安洛替尼组3级或更高AE的发生率高于安慰剂组。

结论

Anlotinib是难治性晚期NSCLC患者的三线或以上三线治疗的有效选择，在PFS，OS，ORR和DCR方面具有临床益处。与阿洛替尼相关的不良事件是可以耐受的。