Efficacy and Safety of Sintilimab in Combination With Anlotinib and Chemoradiotherapy as First-Line Treatment for Driver Gene-Negative Oligometastatic Non-small Cell Lung Cancer: A Real-World Cohort Study.

OBJECTIVE: This study aimed to evaluate the efficacy and safety of sintilimab combined with anlotinib and chemoradiotherapy as first-line treatment for driver gene-negative oligometastatic non-small cell lung cancer (NSCLC). METHODS: This retrospective study included patients with driver gene-negative oligometastatic NSCLC (single organ, ≤2 lesions) treated at the Affiliated Zhangjiagang Hospital of Soochow University (7/2021-12/2023). All patients received 4 cycles of sintilimab plus albumin-bound paclitaxel/carboplatin and achieved partial response or stable disease. Subsequently, patients received concurrent radical radiotherapy with or without anlotinib, or continued the original regimen. Progression-free survival (PFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR), and adverse events were analyzed. RESULTS: A total of 88 patients were included: 27 in the sintilimab plus chemotherapy (SC) group, 32 in the sintilimab plus chemoradiotherapy (SCR) group, and 29 in the anlotinib plus sintilimab and chemoradiotherapy (ASCR) group. The radiotherapy group (SCR + ASCR) showed significantly longer median PFS and OS than the non-radiotherapy group (SC) (7.7 vs. 16.5 months, P < 0.001; 20.1 vs. 31.8 months, P = 0.004). The ASCR group had significantly higher 12-month PFS, 18-month OS, and 24-month OS rates than the SCR group (P = 0.005, 0.014, and 0.046, respectively). ORR and DCR were significantly lower in the non-radiotherapy group (P < 0.001 and P = 0.007). Treatment-related adverse events were manageable. CONCLUSION: In driver gene-negative oligometastatic NSCLC patients benefiting from first-line sintilimab plus chemotherapy, adding concurrent radical radiotherapy significantly improved survival with acceptable toxicity. The addition of anlotinib further enhanced long-term outcomes. These findings are preliminary and require prospective validation.