Abstract
OBJECTIVE: The maintenance treatment with anlotinib can improve the efficacy in advanced non-small cell lung cancer (NSCLC) patients, but the appropriate patient population are still undefined. This study aimed to evaluate the efficacy and safety of adding anlotinib treatment in advanced NSCLC patients who achieved disease stabilization after two cycles of first-line chemotherapy combined with immunotherapy (CIO). MATERIALS AND METHODS: We retrospectively reviewed clinical data of patients with advanced NSCLC who received anlotinib treatment after achieving stable disease (SD) following two cycles of first-line CIO in our hospital. The primary endpoints were progression-free survival (PFS) and overall survival (OS), and the secondary endpoints included objective response rate (ORR), disease control rate (DCR), and Adverse Events (AEs). RESULTS: A total of 38 patients were included in this study. The median age was 65 years (range, 47-77), with 73.68% male and 26.32% female. The median PFS and OS were 6.5 months and 12.0 months, respectively. The ORR and DCR were 34.21% and 68.42%, respectively. Subgroup analysis results showed that patients who experienced hypertension, proteinuria, and hand-foot syndrome during treatment had better efficacy. Mechanistic analysis further suggested that this regimen may enhance the anti-tumor immunity by depleting Tregs, thereby exerting a synergistic effect. Importantly, the overall AEs of this regimen were manageable, supporting the suitability of this treatment modality. CONCLUSION: Adaptive use of Anlotinib could be a safe and effective option in advanced NSCLC patients who achieved SD after two cycles of first-line CIO. This regimen is expected to become an important option for precision and personalized treatment of NSCLC. However, due to the limitations of retrospective nature, its clinical value needs to be further confirmed by prospective studies.