Chemoradiotherapy with or Without Anlotinib for Postoperative Lymph Node Recurrence of Esophageal Squamous Cell Carcinoma: A Real-World Observational Study.

Purpose: Anlotinib, a tyrosine kinase inhibitor, has shown encouraging anti-tumor activity in esophageal squamous cell carcinoma (ESCC). This study present real-world data on the efficacy and safety of chemoradiotherapy (CRT) plus anlotinib versus CRT alone in patients with lymph node recurrence of ESCC after radical resection. Patients and Methods: Patients with lymph node recurrence of ESCC who received CRT with or without anlotinib between January 2017 and December 2019 were retrospectively analyzed. Treatment response, overall survival (OS), progression free survival (PFS) and treatment-related toxicities were compared between groups. Propensity score matching (PSM) analysis was used to balance baseline covariates. Results: A total of 291 ESCC patients with lymph node recurrence received CRT plus anlotinib (n = 76) or CRT alone (n = 215). After PSM, 68 well-balanced patients in each group were included. The partial response rate (58.8% vs 41.2%, p = 0.04) and objective response rate (86.7% vs 61.8%, p = 0.001) were significantly higher in the CRT plus anlotinib group than in the CRT group. Patients in the CRT plus anlotinib group had significantly longer OS (3-year OS, 42.7% vs 23.5%, p = 0.008) and PFS (12-month PFS, 47.1% vs 32.4%, p = 0.026) than those in the CRT group. Multivariate survival analysis revealed that the treatment group (p = 0.007) was an independent predictor of OS. No significant differences were observed in grade 3-4 treatment-related adverse events between the two groups (39.5% vs 30.7%, p = 0.162). Conclusion: Compared with CRT alone, the addition of anlotinib to CRT was safe and provided survival benefits in ESCC patients with lymph node recurrence after radical resection.