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Apatinib vs Placebo in Patients With Locally Advanced or Metastatic, Radioactive Iodine-Refractory Differentiated Thyroid Cancer The REALITY Randomized Clinical Trial

文献类型：期刊论文

作者Lin, Yansong2,3,4; Qin, Shukui5; Li, Zhiyong1; Yang, Hui21; Fu, Wei22; Li, Shaohua23; Chen, Wenxin24; Gao, Zairong25; Miao, Weibing6; Xu, Huiqin7
刊名JAMA ONCOLOGY
出版日期2021-12-16
ISSN号2374-2437
DOI10.1001/jamaoncol.2021.6268
通讯作者Lin, Yansong(linyansong1968@163.com) ; Qin, Shukui(qinsk@csco.org.cn)
英文摘要IMPORTANCE Patients with radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC) have a poor prognosis and limited treatment options. OBJECTIVE To assess the efficacy and safety of apatinib, a highly selective vascular endothelial growth factor (VEGFR-2) inhibitor, in patients with progressive locally advanced or metastatic RAIR-DTC. DESIGN, SETTING, AND PARTICIPANTS This randomized, double-blind, placebo-controlled, phase 3 trial (Efficacy of Apatinib in Radioactive Iodine-refractory Differentiated Thyroid Cancer [REALITY]) was conducted in 92 patients with progressive locally advanced or metastatic RAIR-DTC between February 17, 2017, and March 2, 2020, at 21 sites within China, and the data cutoff date for this analysis was March 25, 2020. INTERVENTIONS Patients were randomly assigned (1:1) to apatinib, 500 mg/d, or placebo. Patients who developed progression while receiving placebo were allowed to cross over to apatinib. MAIN OUTCOMES AND MEASURES The primary end point was investigator-assessed progression-free survival (PFS). Secondary end points included overall survival, objective response rate (ORR), disease control rate (DCR), duration of response, time to objective response, and safety. Intention-to-treat analyses were performed to evaluate efficacy. RESULTS Of the 92 patients included in the trial, 56 were women (60.9%); mean (SD) age at baseline was 55.7 (10.6) years. Patients were randomized to the apatinib (n = 46) or placebo (n = 46) group. The median follow-up duration was 18.1 (IQR, 12.7-22.2) months. The median PFS was 22.2 (95% CI, 10.91-not reached) months for apatinib vs 4.5 (95% CI, 1.94-9.17) months for placebo (hazard ratio, 0.26; 95% CI, 0.14-0.47; P < .001). The confirmed ORR was 54.3% (95% CI, 39.0%-69.1%) and the DCR was 95.7% (95% CI, 85.2%-99.5%) in the apatinib group vs an ORR of 2.2% (95% CI, 0.1%-11.5%) and DCR of 58.7% (95% CI, 43.2%-73.0%) in the placebo group. The median overall survival was not reached for apatinib (95% CI, 26.25-not reached) and was 29.9 months (95% CI, 18.96-not reached) for placebo (hazard ratio, 0.42; 95% CI, 0.18-0.97; P = .04). The most common grade 3 or higher-level treatment-related adverse events in the apatinib group were hypertension (16 [34.8%]), hand-foot syndrome (8 [17.4%]), proteinuria (7 [15.2%]), and diarrhea (7 [15.2%])-none of which occurred in the placebo group. CONCLUSIONS AND RELEVANCE The REALITY trial met its primary end point of PFS at the prespecified interim analysis. Apatinib showed significant clinical benefits in both prolonged PFS and overall survival with a manageable safety profile in patients with progressive locally advanced or metastatic RAIR-DTC.
WOS关键词DOUBLE-BLIND ; DISTANT METASTASES ; TYROSINE KINASE ; CARCINOMA ; LENVATINIB ; CABOZANTINIB ; MULTICENTER ; MANAGEMENT ; SORAFENIB ; INHIBITOR
资助项目National Natural Science Foundation of China[81771875] ; Project on Inter-Governmental International Scientific and Technological Innovation Cooperation in the National Key Projects of Research and Development Plan[2019YFE0106400] ; Jiangsu Hengrui Pharmaceuticals Co Ltd
WOS研究方向Oncology
语种英语
出版者AMER MEDICAL ASSOC
WOS记录号WOS:000731127300003
资助机构National Natural Science Foundation of China ; Project on Inter-Governmental International Scientific and Technological Innovation Cooperation in the National Key Projects of Research and Development Plan ; Jiangsu Hengrui Pharmaceuticals Co Ltd
源URL[http://ir.hfcas.ac.cn:8080/handle/334002/126958]  
专题中国科学院合肥物质科学研究院
通讯作者Lin, Yansong; Qin, Shukui
作者单位1.Xuzhou Med Univ, Dept Nucl Med, Affiliated Hosp, Xuzhou, Jiangsu, Peoples R China
2.Peking Union Med Coll Hosp, Dept Nucl Med, Beijing, Peoples R China
3.Beijing Key Lab Mol Targeted Diag & Therapy Nucl, Beijing, Peoples R China
4.Chinese Acad Med Sci & Peking Union Med Coll, Peking Union Med Coll Hosp, State Key Lab Complex Severe & Rare Dis, Beijing, Peoples R China
5.Nanjing Chinese Med Univ, Canc Ctr Bayi Hosp, Dept Med Oncol, Nanjing, Peoples R China
6.Fujian Med Univ, Dept Nucl Med, Fujian Prov Key Lab Precis Med Canc, Affiliated Hosp 1, Fuzhou, Peoples R China
7.Anhui Med Univ, Dept Nucl Med, Affiliated Hosp 1, Hefei, Peoples R China
8.Nanchang Univ, Dept Nucl Med, Affiliated Hosp 1, Nanchang, Jiangxi, Peoples R China
9.Hebei Med Univ, Dept Nucl Med, Hosp 4, Shijiazhuang, Hebei, Peoples R China
10.Jiangsu Inst Nucl Med, Dept Endocrinol, JiangYuan Hosp, Wuxi, Jiangsu, Peoples R China
推荐引用方式
GB/T 7714		 Lin, Yansong,Qin, Shukui,Li, Zhiyong,et al. Apatinib vs Placebo in Patients With Locally Advanced or Metastatic, Radioactive Iodine-Refractory Differentiated Thyroid Cancer The REALITY Randomized Clinical Trial[J]. JAMA ONCOLOGY,2021.
APA Lin, Yansong.,Qin, Shukui.,Li, Zhiyong.,Yang, Hui.,Fu, Wei.,...&Hou, Zhiguo.(2021).Apatinib vs Placebo in Patients With Locally Advanced or Metastatic, Radioactive Iodine-Refractory Differentiated Thyroid Cancer The REALITY Randomized Clinical Trial.JAMA ONCOLOGY.
MLA Lin, Yansong,et al."Apatinib vs Placebo in Patients With Locally Advanced or Metastatic, Radioactive Iodine-Refractory Differentiated Thyroid Cancer The REALITY Randomized Clinical Trial".JAMA ONCOLOGY (2021).

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来源：合肥物质科学研究院

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