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Anlotinib in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma: A Randomized, Double-Blind, Multicenter Phase II Trial

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...

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Autores principales: Chi, Yihebali, Zheng, Xiangqian, Zhang, Yuan, Shi, Feng, Cheng, Ying, Guo, Zhuming, Ge, Minghua, Qin, Jianwu, Zhang, Jiewu, Li, Zhendong, Zhou, Xiaohong, Huang, Rui, Chen, Xiaohong, Liu, Hui, Cheng, Ruochuan, Xu, Zhengang, Li, Dapeng, Tang, Pingzhang, Gao, Ming
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Association for Cancer Research 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10570678/
https://www.ncbi.nlm.nih.gov/pubmed/37594724
http://dx.doi.org/10.1158/1078-0432.CCR-22-3406
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author Chi, Yihebali
Zheng, Xiangqian
Zhang, Yuan
Shi, Feng
Cheng, Ying
Guo, Zhuming
Ge, Minghua
Qin, Jianwu
Zhang, Jiewu
Li, Zhendong
Zhou, Xiaohong
Huang, Rui
Chen, Xiaohong
Liu, Hui
Cheng, Ruochuan
Xu, Zhengang
Li, Dapeng
Tang, Pingzhang
Gao, Ming
author_facet Chi, Yihebali
Zheng, Xiangqian
Zhang, Yuan
Shi, Feng
Cheng, Ying
Guo, Zhuming
Ge, Minghua
Qin, Jianwu
Zhang, Jiewu
Li, Zhendong
Zhou, Xiaohong
Huang, Rui
Chen, Xiaohong
Liu, Hui
Cheng, Ruochuan
Xu, Zhengang
Li, Dapeng
Tang, Pingzhang
Gao, Ming
author_sort Chi, Yihebali
collection PubMed
description 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.
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spelling pubmed-105706782023-10-14 Anlotinib in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma: A Randomized, Double-Blind, Multicenter Phase II Trial Chi, Yihebali Zheng, Xiangqian Zhang, Yuan Shi, Feng Cheng, Ying Guo, Zhuming Ge, Minghua Qin, Jianwu Zhang, Jiewu Li, Zhendong Zhou, Xiaohong Huang, Rui Chen, Xiaohong Liu, Hui Cheng, Ruochuan Xu, Zhengang Li, Dapeng Tang, Pingzhang Gao, Ming Clin Cancer Res Clinical Trials: Targeted Therapy 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. American Association for Cancer Research 2023-10-13 2023-08-18 /pmc/articles/PMC10570678/ /pubmed/37594724 http://dx.doi.org/10.1158/1078-0432.CCR-22-3406 Text en ©2023 The Authors; Published by the American Association for Cancer Research https://creativecommons.org/licenses/by-nc-nd/4.0/This open access article is distributed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) license.
spellingShingle Clinical Trials: Targeted Therapy
Chi, Yihebali
Zheng, Xiangqian
Zhang, Yuan
Shi, Feng
Cheng, Ying
Guo, Zhuming
Ge, Minghua
Qin, Jianwu
Zhang, Jiewu
Li, Zhendong
Zhou, Xiaohong
Huang, Rui
Chen, Xiaohong
Liu, Hui
Cheng, Ruochuan
Xu, Zhengang
Li, Dapeng
Tang, Pingzhang
Gao, Ming
Anlotinib in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma: A Randomized, Double-Blind, Multicenter Phase II Trial
title Anlotinib in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma: A Randomized, Double-Blind, Multicenter Phase II Trial
title_full Anlotinib in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma: A Randomized, Double-Blind, Multicenter Phase II Trial
title_fullStr Anlotinib in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma: A Randomized, Double-Blind, Multicenter Phase II Trial
title_full_unstemmed Anlotinib in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma: A Randomized, Double-Blind, Multicenter Phase II Trial
title_short Anlotinib in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma: A Randomized, Double-Blind, Multicenter Phase II Trial
title_sort anlotinib in locally advanced or metastatic radioiodine-refractory differentiated thyroid carcinoma: a randomized, double-blind, multicenter phase ii trial
topic Clinical Trials: Targeted Therapy
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10570678/
https://www.ncbi.nlm.nih.gov/pubmed/37594724
http://dx.doi.org/10.1158/1078-0432.CCR-22-3406
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