Real‐World Study of Later‐Line Anlotinib in R/M Head and Neck Squamous Cell Carcinoma

ABSTRACT Objectives The option is rare for patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) failed to prior‐line immune checkpoint inhibitors (ICIs) and cetuximab‐based treatment. The efficacy of salvage therapy was unsatisfied. Materials and Methods We collected the clinical data of R/M HNSCC patients progressed from prior‐line immunotherapy and cetuximab therapy, and retrospectively analyzed the efficacy and toxicity of anlotinib‐based therapy in these patients. Results In total, 24 eligible participants were accrued between October 2021 and November 2024. Up to the cutoff time of November 1st, 2024, the objective response rate was 37.5%. Survival analysis revealed the median progression‐free survival and overall survival was 4.27 months (95% CI, 1.53–7.01 months) and 8.67 months (95% CI, 5.62–11.72 months), respectively. For the safety, most common TRAEs with any grades were hypertension, hand–foot syndrome, gastrointestinal response, hemorrhage, hepatic dysfunction, and fatigue. Grade 3 or more TRAEs were observed in 3 (12.5%) patients, and no Grade 5 TRAEs were occurred. Conclusions Our observations indicated that anlotinib‐based therapy had considerable efficacy and well tolerance in R/M HNSCC patients failed to ICIs and cetuximab‐based therapy, and might be acted as a novel and potentially effective option in later‐line treatment of R/M HNSCC.