Your new experience awaits. Try the new design now and help us make it even better

CLINICAL TRIAL article

Front. Oncol.

Sec. Head and Neck Cancer

Volume 15 - 2025 | doi: 10.3389/fonc.2025.1622676

This article is part of the Research TopicAdvancements in Personalized Medicine for Head and Neck Cancer: Molecular-based Approaches to Treatment and CareView all 5 articles

Efficacy and Safety of Anlotinib in combination with ¹³¹I Therapy in the Treatment of Distant Metastatic Differentiated Thyroid Cancer: A Single-arm, Phase

Provisionally accepted
Yan  LiYan Li1Jianjing  LiuJianjing Liu1,2Qian  SuQian Su2Xueyao  LiuXueyao Liu1Zhen  YangZhen Yang3Zhao  YangZhao Yang2Jie  FuJie Fu2Yan  ZhangYan Zhang1Lina  TongLina Tong1Fang  YangFang Yang1Dong  DaiDong Dai1,2*
  • 1Department of Nuclear Medicine, Tianjin Cancer Hospital Airport Hospital, Tianjin, China
  • 2Department of Molecular Imaging and Nuclear Medicine, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China
  • 3Department of Nuclear Medicine,, Tianjin Cancer Hospital Airport Hospital, Tianjin, China

The final, formatted version of the article will be published soon.

Radioactive iodine (RAI) is the standard treatment for distant metastatic differentiated thyroid cancer (dmDTC). However, many patients fail to achieve satisfactory effects and prognosis. Anlotinib is a highly effective antiangiogenic tyrosine kinase inhibitor (TKI) that has shown promising efficacy in RAIR-DTC patients. This study evaluated the efficacy and safety of anlotinib in combination with 131 I in dmDTC.The key eligible criteria included patients with dmDTC who had at least one measurable metastatic lesion capable of iodine uptake and were planned to receive RAI therapy. Previous treatment with TKI was not permitted. Patients underwent a whole-body iodine scan (Rx-WBS) following iodine administration on days 3-5. When confirmed iodine uptake in metastatic lesions, anlotinib would be given at 12 mg (QD, 2 weeks on/1 week off, Q3W) initially. One combination treatment cycle consisted of 12 weeks of anlotinib and 1 dose of iodine-131. The primary endpoints were the objective response rate (ORR) and changes in thyroglobulin (Tg) levels. The secondary endpoints included disease control rate (DCR), progression-free survival (PFS), and safety.From October 2022 to September 2024, 20 patients (4 males and 16 females) with distant metastatic DTC were enrolled. All patients who had completed at least one cycle of combined treatment were eligible for data analysis. The median follow-up was 13.7 months. 11 patients achieved partial response (PR), 8 patients achieved stable disease (SD), and 1 patient had progressive disease (PD). ORR and DCR were 55.0% [95% Confidence Interval (CI): 31.5%-76.9%] and 94.7% (95% CI: 75.1%-99.9%) respectively. Median PFS was not reached. All patients achieved a biochemical response according to protocol-defined criteria, defined as a ≥25% decrease in Tg levels. Grade 3 or higher treatment-related adverse events (TRAEs) were observed in 10 (50%; most common hypertension) patients. Dose reductions of anlotinib were required in 10 (50%) patients due to AEs, and no patient discontinued treatment because of AEs. No serious adverse events (SAEs) or deaths were reported.This study demonstrates the promising efficacy and safety of combining the TKI with 131 I therapy, suggesting that anlotinib may be a viable option for dmDTC.

Keywords: Anlotinib, 131I therapy, Distant metastatic differentiated thyroid cancer, efficacy, Safety

Received: 04 May 2025; Accepted: 30 Jun 2025.

Copyright: © 2025 Li, Liu, Su, Liu, Yang, Yang, Fu, Zhang, Tong, Yang and Dai. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Dong Dai, Department of Nuclear Medicine, Tianjin Cancer Hospital Airport Hospital, Tianjin, China

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.