[A real-world study on anlotinib-targeted neoadjuvant therapy for locally advanced thyroid cancer]

Objective: To assess the real-world data of thyroid cancer patients with neoadjuvant treatment of anlotinib, and to evaluate the clinical efficacy, safety and correlation with molecular characteristics. Methods: Patients with locally advanced thyroid cancer were treated with neoadjuvant therapy with 10 mg anlotinib from April 2021 to June 2025. Statistical analysis was performed on patient demographics, molecular characteristics, changes in target lesions before and after targeted therapy, treatment-related adverse events, imaging CT values, and surgical rates. Results: A total of 24 patients were enrolled, including 21 of papillary carcinoma, 2 of high-grade differentiated thyroid cancer, and 1 of follicular carcinoma with medullary carcinoma. Eighteen were treatment-naïve patients, and 6 were relapsed patients after treatment. Fifty percent of patients were in the T4b stage. Of 24 patients, 17 underwent genetic testing, and mutations were detected in 15 patients, including 8 with mutations in two genes and 2 with mutations in three genes. Six patients had an ECOG performance status of 0 score, 8 patients with 1 score, and 10 patients with 2 scores. There were 6 patients of partial response, 18 of stable disease, and no progressive disease patients. The objective response rate was 25% and the disease control rate was 100%. The CT value of imaging was significantly reduced after targeted therapy (t=2.589, P=0.017). Among of the 24 patients, 16 (66.67%) underwent surgery. The surgical conversion rate in T4b stage patients was 75%(9/12). The average medication cycle was 5.91 cycles. The main treatment-related adverse events were hypertension (6/24), proteinuria (3/24), and palmar-plantar erythrodysesthesia syndrome (5/24). Adverse events were grade Ⅰ-Ⅱ, and no Ⅲ-Ⅳ grade adverse events occurred. The average follow-up time was 24.79 months. Conclusion: Anlotinib can be used as a preoperative neoadjuvant treatment for patients with locally advanced thyroid cancer, and the initial dose of 10 mg can ensure both efficacy and safety.