Three‐Year Follow‐Up of the Phase II Trial for Resectable Non‐Small‐Cell Lung Cancer Treated With Perioperative Sintilimab and Neoadjuvant Anlotinib Plus Chemotherapy: TD ‐ NeoFOUR Trial

BACKGROUND: Lung cancer is a leading cause of cancer-related deaths. Perioperative therapies, including neoadjuvant chemo-immunotherapy, have improved outcomes, but combining them with antiangiogenic drugs may offer further benefits. This study evaluated the 3-year efficacy and safety of neoadjuvant sintilimab, anlotinib, and chemotherapy in resectable NSCLC patients from the TD-NeoFOUR trial. METHODS: The study included 45 patients who received neoadjuvant treatment with anlotinib, sintilimab, and platinum-based chemotherapy. The primary endpoint was overall survival (OS), and the secondary endpoint was event-free survival (EFS). The Kaplan-Meier method was used to estimate survival curves, and the log-rank test was used to compare survival rates between subgroups. RESULTS: As of November 11, 2024, all 45 patients had been followed up for a median of 35.7 months. The estimated 3-year EFS rate was 84.3%, and the estimated 3-year OS rate was 86.7%. Subgroup analysis showed that patients achieving pathological complete response (pCR) and major pathological response (MPR) had significantly higher 3-year EFS and OS rates compared to patients with non-pCR and non-MPR. No new treatment-related adverse events (TRAEs) occurred during the 3-year follow-up, indicating the long-term safety of the treatment regimen. CONCLUSIONS: The combination of neoadjuvant chemo-immunotherapy and antiangiogenic drugs significantly improved long-term survival outcomes in patients with resectable NSCLC. This treatment regimen is a promising option for improving prognosis in this patient population.