Objective  To systematically review the efficacy and safety of the tislelizumab combined with anlotinib regimen for advanced non-small-cell lung cancer (NSCLC) patients.

Methods  PubMed, Embase, Cochrane Library, Web of Science, CNKI, WanFang Data databases were electronically searched to collect clinical studies on the combination of trastuzumab and anlotinib in the treatment of advanced NSCLC patients from inception to August 10, 2024. Two reviewers independently screened literature, extracted data and assessed the risk of bias of the included studies. Meta-analysis was then performed by using RevMan 5.4.1 software.

Results  A total of 6 articles of 468 patients were included, involving 4 randomized controlled trials and 2 prospective cohort studies. Meta-analysis showed that the tislelizumab combined with anlotinib group had higher ORR [OR=2.53, 95%CI (1.62, 3.93), P<0.001] and DCR [OR=4.45. 95%CI (2.43, 8.15), P<0.001] than the anlotinib group. The CYFRA21-1 level in the combination group was significantly lower than that in the anlotinib group [SMD=-1.07, 95%CI (-1.63, -0.51), P<0.001]. For safety, there were no significant differences in the incidence of adverse reaction of leukopenia [OR=0.91, 95%CI (0.39, 2.14), P=0.83], liver/kidney dysfunction [OR=1.16, 95%CI (0.39, 3.44) P=0.78]. The descriptive analysis results indicated that there was no statistically significant difference in CEA levels between the two groups before treatment in each study (P>0.05), and the CEA levels in the combination therapy group were lower than those in the anlotinib group after treatment (P<0.05).

Conclusion  Compared to anlotinib alone, tislelizumab combined with anlotinib improves ORR, DCR, and reduces tumor markers in NSCLC patients, with comparable incidence of adverse reactions. Due to the limited quality and quantity of the included studies, more high quality studies are needed to verify the above conclusion.

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