Related Experiment Video
Updated: Jul 19, 2025
Establishment and Characterization of Patient-Derived Xenograft Models of Anaplastic Thyroid Carcinoma and Head and Neck Squamous Cell Carcinoma
Published on: June 2, 2023
Anlotinib in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma: A Randomized,
Yihebali Chi1, Xiangqian Zheng2, Yuan Zhang3
1Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Purpose:
Alhough antiangiogenic agents are the bedrock of treatment for radioiodine-refractory differentiated thyroid carcinoma (RAIR-DTC), novel antiangiogenic agents with optimized features like greater target-binding affinities and more favorable pharmacokinetics profile are needed. This phase II randomized, double-blind, placebo-controlled trial investigated the efficacy and safety of anlotinib, a multikinase inhibitor, for RAIR-DTC.
Patients And Methods:
Patients (ages between 18 and 70 years) with pathologically confirmed locally advanced or metastatic RAIR-DTC were enrolled and randomly received 12 mg anlotinib once daily or placebo on day 1 to 14 every 3 weeks. Patients on placebo were allowed to receive open-label anlotinib after disease progression. The primary endpoint was progression-free survival (PFS). The secondary endpoints included overall survival (OS) and safety.
Results:
Between September 2015 and August 2018, 76 and 37 patients randomly received anlotinib and placebo, respectively. Patients receiving anlotinib had a significantly longer median PFS [40.5 months, 95% confidence interval (CI), 28.3-not estimable (NE) versus placebo 8.4 months, 95% CI, 5.6-13.8; HR = 0.21, 95% CI, 0.12-0.37, P < 0.001], meeting the primary endpoint. OS was still immature, with a trend of benefit with anlotinib (HR = 0.57, 95% CI, 0.29-1.12). All patients in the anlotinib group experienced adverse events (AE); 8 (10.5%) discontinued treatment due to AEs.
Conclusions:
Anlotinib demonstrated promising efficacy and favorable tolerance in the treatment of locally advanced or metastatic RAIR-DTC, supporting further research to establish its role in the treatment of this serious disease.
Insights
Anlotinib significantly improved progression-free survival in patients with radioiodine-refractory differentiated thyroid carcinoma (RAIR-DTC). This multikinase inhibitor showed promising efficacy and favorable safety, warranting further investigation for advanced RAIR-DTC.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Radioiodine-refractory differentiated thyroid carcinoma (RAIR-DTC) requires novel antiangiogenic agents.
- Existing treatments need optimization for greater target-binding and improved pharmacokinetics.
Purpose of the Study:
- To investigate the efficacy and safety of anlotinib, a multikinase inhibitor, in patients with RAIR-DTC.
- To evaluate anlotinib's potential as a novel antiangiogenic therapy for advanced RAIR-DTC.
Main Methods:
- Phase II, randomized, double-blind, placebo-controlled trial.
- 12 mg anlotinib daily (14 days/3 weeks) or placebo in locally advanced/metastatic RAIR-DTC patients (18-70 years).
- Primary endpoint: Progression-Free Survival (PFS); Secondary endpoints: Overall Survival (OS) and safety.
Main Results:
- Anlotinib significantly prolonged median PFS (40.5 months vs. 8.4 months; HR=0.21, P<0.001).
- A trend of overall survival benefit was observed with anlotinib (HR=0.57).
- All anlotinib patients experienced adverse events; 10.5% discontinued due to AEs.
Conclusions:
- Anlotinib demonstrates promising efficacy and favorable tolerance in treating advanced RAIR-DTC.
- Further research is supported to establish anlotinib's role in RAIR-DTC treatment.
- Anlotinib represents a potential new therapeutic option for this challenging disease.
