Efficacy and safety analysis of anlotinib combined with PD-1 inhibitors in advanced non-small cell lung cancer: a retrospective cohort study

BACKGROUND: Programmed cell death 1 (PD-1) inhibitors are beneficial for patients with advanced lung cancer. However, the population who will benefit from PD-1 inhibitors is limited, and their efficacy needs to be further improved. Antiangiogenic agents may regulate tumor microenvironment to improve immunotherapy efficacy. This real-world study sought to investigate the efficacy and safety of anlotinib combined with PD-1 inhibitors in the treatment of advanced non-small cell lung cancer (NSCLC). METHODS: In total, 42 advanced NSCLC patients were included in this retrospective study. All the patients received anlotinib combined with PD-1 inhibitors from May 2020 to November 2022. The progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs) of the patients were evaluated. RESULTS: The patients had an overall median PFS of 5.721 months [95% confidence interval (CI): 1.365–10.076]. The median PFS and ORRs of the male patients compared to the female patients were 10.553 vs. 4.340 months, and 36.4% vs. 0.0%, respectively (P=0.010 and 0.041). The DCRs for the first-, second-, and third-line therapies were 100%, 83.3%, and 64.3%, respectively (P=0.096). In relation to the pathological types, the ORRs of the sarcoma, squamous, and adenocarcinoma patients were 100.0%, 33.3%, and 18.5%, respectively (P=0.025). The DCRs of patients with the tumor protein 53 (TP53) mutation, other status, and epidermal growth factor receptor (EGFR) mutations were 100.0%, 81.5%, and 40.0%, respectively (P=0.020). All-grade AEs occurred in 52.38% of the patients. The grade 3 AEs were hypertension (7.14%), pneumonia (2.38%), and oral mucositis (2.38%). In total, 3 patients discontinued treatment due to anemia, oral mucositis, and pneumonia, respectively. CONCLUSIONS: Anlotinib combined with PD-1 inhibitors has potentially good efficacy and a tolerated safety profile in the treatment of advanced NSCLC patients.