OBJECTIVE

To investigate the clinical effectiveness of combining Anlotinib (ANB) and programmed death-1 receptor (PD-1) inhibitors in treating advanced non-small-cell lung carcinoma (aNSCLC) patients.

METHODS

The study included 400 aNSCLC patients treated at Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine between January 2021 and June 2024. The control group (192 cases) received PD-1 inhibitor therapy, while the observation group (208 cases) received ANB + PD-1 inhibitor therapy. Comparative analyses were conducted between the two groups regarding clinical effectiveness, safety (nausea and vomiting, hand-foot syndrome, fatigue, decreased appetite, and anemia), coagulation function (thrombin time [TT], activated partial thromboplastin time [APTT], and fibrinogen [FIB]), serum biochemical indices (vascular endothelial growth factor [VEGF] and matrix metalloproteinase-2 [MMP-2]); immune function (immunoglobulin G/A/M (IgG/IgA/IgM)), serum tumor markers (carcinoembryonic antigen [CEA], carbohydrate antigen 125 [CA125], and cytokeratin 19 fragment antigen [CYFRA21-1]), sleep quality (Pittsburgh Sleep Quality Index [PSQI]), and short-term prognosis (Karnofsky Performance Status Scale [KPS]). Binary logistic regression was used to identify risk factors affecting clinical effectiveness and short-term prognosis.

RESULTS

The observation group showed significantly higher objective response and disease control rates compared to the control group (P < 0.001). Treatment modality was identified as a risk factor for clinical effectiveness (P < 0.001). Adverse reaction incidence was comparable between the groups (all P > 0.05), except for grade III-IV hand-foot syndrome and decreased appetite. TT showed no significant differences within or between groups (P > 0.05), but APTT and FIB increased significantly after treatment in the observation group, surpassing the control group (all P < 0.05). VEGF and MMP-2 levels decreased significantly after treatment in the observation group, with values lower than in the control group (P < 0.05). IgG, IgA, and IgM levels were markedly higher in the observation group after treatment, with improved PSQI and KPS scores compared to the control group (all P < 0.05). Serum tumor markers (CEA, CA125, CYFRA21-1) also decreased significantly in the observation group (all P < 0.05). VEGF was identified as a risk factor for short-term prognosis (P = 0.047).

CONCLUSION

The combination of ANB and PD-1 inhibitors demonstrates significant effectiveness in aNSCLC patients, improving coagulation function, serum biochemical indices, immune function, sleep quality, and short-term prognosis without markedly increasing adverse reactions.