Abstract
Purpose This study is aimed at investigating the clinical safety and effectiveness of anlotinib combined with immune checkpoint inhibitors (ICIs) in the treatment of non-small-cell lung cancer (NSCLC). Methods We selected 68 NSCLC patients treated at the Tumor Hospital Affiliated to Nantong University from October 2019 to January 2022. Patients receiving ICI monotherapy were included in the control group (n = 36), whereas patients receiving anlotinib combined with ICIs were enrolled in the study group (n = 32). The survival, adverse reactions (AEs), and short-term clinical effectiveness of the two groups were observed. The tumor markers (vascular endothelial growth factor (VEGF), carcino-embryonic antigen (CEA), and squamous cell carcinoma antigen (SCC-AG)) and T lymphocyte subsets (CD3+, CD4+, CD8+, and CD4+/CD8+) were determined before and after treatment. Results Compared with the control group, the disease-control rate (DCR) and objective response rate (ORR) in the study group were substantially higher than that of the control group (62.50 vs. 36.11, 81.25 vs. 55.56; P < 0.05). The serum levels of VEGF, CEA, and SCC-AG in the two groups were considerably lower after two cycles of treatment (P < 0.05), and the serum levels of VEGF, CEA, and SCC-AG in the study group were significantly lower than those in the control group (P < 0.05). Following therapy, CD8+ in both groups decreased dramatically (P < 0.05), whereas CD3+, CD4+, and CD4+/CD8+ were significantly increased, but there was no statistical difference between the two groups (P > 0.05). The incidence of gastrointestinal, respiratory, cardiovascular, and immune-related adverse events did not significantly differ between the two groups (P > 0.05). The median progression-free survival (PFS) in the control and study groups for the first-line treatment patients was 7.2 and 9.8 months, respectively, whereas for the second-line treatment patients, it was 4.2 and 6.4 months, respectively. The mean PFS of study group was substantially longer than that of the control group regardless of the first- or second-line treatment. According to Cox analysis, the number of drug lines and TNM stage was independent risk variables impacting the prognosis of patients in this study. Conclusion The combination of anlotinib with ICIs was more effective than either agent alone in the first- and second-line treatment of patients with advanced NSCLC. This treatment regimen did not interfere with immunological recovery or increase side effects.
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