Efficacy and safety of anlotinib combined with immunotherapy as first-line treatment in elderly patients with advanced non-small cell lung cancer

Background: As the global population ages, the incidence of lung cancer among elderly patients has shown a significant upward trend. In elderly patients, the treatment options are often limited due to comorbidities and decreased tolerance to aggressive therapies. Anlotinib, a novel multi-target tyrosine kinase inhibitor, has shown promising antitumor activity in various solid tumors. Programmed cell death protein 1 (PD-1) inhibitors have also demonstrated significant efficacy in the treatment of non-small cell lung cancer (NSCLC). This retrospective study aimed to evaluate the efficacy and safety of anlotinib in combination with PD-1 inhibitors as first-line treatment in elderly patients with advanced NSCLC. Methods: We conducted a retrospective cohort study between 2019 and 2023, enrolling 40 patients with advanced NSCLC aged over 65 years. Participants received a combination regimen of anlotinib (8-12 mg/day, administered on a 2/1 cycle schedule) with PD-1 inhibitors. The primary endpoint was progression-free survival (PFS), with secondary endpoints including objective response rate (ORR), disease control rate (DCR), and safety assessment. Results: The median PFS was 15.87 months. The ORR reached 47.5%, and the DCR was 97.5%. Multivariate analysis identified bone metastasis (PFS 18.37 vs. 3.80 months, P<0.001) and pleural metastasis (PFS 18.37 vs. 4.43 months, P=0.02) as independent prognostic factors. Grade >= 3 adverse events (AEs) were observed in only 3 patients, including interstitial pneumonia (n=1) and hand-foot syndrome (n=2). Conclusions: Our findings suggest that the combination of anlotinib and immunotherapy represents a promising first-line therapeutic approach for elderly patients with locally advanced NSCLC, characterized by meaningful clinical efficacy and an acceptable safety profile. Further investigation may be warranted to validate the long-term therapeutic value of this treatment regimen in the elderly population.