Efficacy and Safety of Different Dosages of Anlotinib Combined with PD-1 Monoclonal Antibody in the Treatment of Advanced Non-Small Cell Lung Cancer.

[OBJECTIVE] This study investigates the efficacy and safety of anlotinib in combination with PD-1 monoclonal antibody across different dosing regimens for advanced non-small cell lung cancer (NSCLC). It aims to determine whether a medium dosage provides the best therapeutic outcomes.

[METHODS] A retrospective analysis was conducted on 100 NSCLC patients treated between July 2018 and December 2022. Patients were divided into three groups based on anlotinib dose: low (8 mg/d,  = 38), medium (10 mg/day,  = 34), and high (12 mg/d,  = 28), all receiving 200 mg of PD-1 antibody every 21 days. The primary endpoint was overall survival (OS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), and quality of life (QoL) assessed via the EORTC QLQ-C30 questionnaire.

[RESULTS] Median OS was significantly higher in the medium-dose group (21.3 months) compared to the low-dose group (10.2 months;  = 0.01). The high-dose group achieved a median OS of 18.2 months ( = 0.10 vs. medium). ORRs were 26%, 54%, and 42%, and DCRs were 66%, 82%, and 80% for low, medium, and high groups, respectively. QoL scores in the medium group were significantly improved in physical, emotional, and social domains ( < 0.05). Adverse events of grade ≥3 occurred in 18%, 19%, and 29% of patients in the low, medium, and high-dose groups, respectively. Immune-related side effects, such as thyroid dysfunction, increased with dosage ( = 0.018).

[CONCLUSION] Medium-dose anlotinib combined with PD-1 therapy delivers superior survival and QoL outcomes with manageable toxicity. These results underscore its potential as an optimal treatment strategy for advanced NSCLC.