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This retrospective study investigated the impact of adding anlotinib, a tyrosine kinase inhibitor, to radiotherapy and immunotherapy in 203 patients with stage IIIB-IV driver gene-negative NSCLC. The addition of anlotinib improved median progression-free survival (PFS) from 6.0 to 10.0 months, with a trend toward improved overall survival that did not reach statistical significance. The triple therapy also demonstrated a higher objective response rate (ORR) but increased toxicity.
Adding anlotinib to radiotherapy and immunotherapy for advanced NSCLC improves progression-free survival, but the increased toxicity and lack of overall survival benefit warrant careful consideration.
Background Radiotherapy paired with immune checkpoint inhibitors (ICIs) has benefited patients with driver gene-negative NSCLC, although treatment resistance remains an obstacle. Anlotinib, a broad-spectrum tyrosine kinase inhibitor, has potential to reinforce immunotherapy by modifying the tumor environment. This study investigates whether incorporating anlotinib can amplify the efficacy of combined treatment protocols. Methods A total of 203 individuals diagnosed with stage IIIB-IV NSCLC were retrospectively assessed. Treatment occurred at the First Affiliated Hospital of Bengbu Medical University between 2021 and 2023. Patients were grouped into those receiving radiotherapy and immunotherapy (n=123) and those receiving anlotinib in addition (n=80). Clinical outcomes assessed included PFS, OS, response metrics, and treatment-related side effects. Results Over a median follow-up of 26 months, the group receiving anlotinib showed enhanced median PFS (10.0 months vs 6.0 months, P = 0.043 HR: 0.708, 95% CI: 0.496-1.009). However, there was no statistically significant difference in overall survival (OS) between the two groups (median OS: 20.0 vs. 18.0 months; P = 0.344, HR:0.848 95% CI:0.597-1.205). the RT+IO+A regimen demonstrated a 10% higher ORR than the RT+IO regimen (45.0% vs. 35.0%), while the DCR was similar between the two groups (88.8% vs. 91.1%). Toxic effects were manageable but more frequent in the triple-therapy group. Conclusion The triple regimen improved disease stabilization but did not yield OS benefits. Due to the increased toxicity associated with the addition of anlotinib, Future research is required to weigh advantages against added toxicity.