The Efficacy and Safety of Anlotinib in Neoadjuvant Treatment of Locally Advanced Thyroid Cancer: A Single-Arm Phase II Clinical Trial

• DOI: 10.1089/thy.2021.0307
• Publication Date: 2021-10-06T07:28:37Z
• Authors: Nai-si Huang; Wen-jun Wei; Jun Xiang; Jia-ying Chen; Qing Guan; Zhong-wu Lu; Ben Ma; Guo-hua Sun; Yu-long Wang; Qing-hai Ji; Yu Wang
• Keywords: Medullary Thyroid Cancer; Clinical endpoint; Neoadjuvant Therapy

Background: Surgery is the primary treatment for locally advanced thyroid cancer. For some cases, R0/R1 resection could not be achieved at initial diagnosis and neoadjuvant would an option. Anlotinib a multitarget tyrosine kinase inhibitor, which demonstrated antitumor activity in radioiodine-refractory differentiated cancer medullary We aimed to evaluate efficacy safety of anlotinib setting. Methods: This single-arm phase II study investigated (12 mg orally daily, 2 weeks on/1 week off) 2-6 cycles patients with The key eligibility criteria included age 14-80 years old; that benefit from surgery, least one measurable lesion. Operable received surgery after treatment. endpoint was objective response rate (ORR). Results: A total 13 were enrolled average 3.5 ORR 76.9% (95% confidence interval: 46.2-95.0%). intent-to-treat population 61.5% per-protocol 72.7%. median time 61.5 days, disease control 18 92.3%. No had blood transfusion or tracheotomy. Most adverse events (AEs) grade 1 tended discontinue when ceased. Common AEs all grades hypertension (76.9%), hypertriglyceridemia (69.2%), proteinuria (53.8%), thyrotropin increase cholesterol elevation hand-foot syndrome (38.5%). Conclusions: majority resection. consistent known AE profile. These results suggest represents new option Clinical Trial Registration Number: NCT04309136.