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Anlotinib in Locally Advanced or Metastatic Medullary Thyroid Carcinoma: A Randomized, Double-Blind Phase IIB Trial

文献类型：期刊论文

作者Li, Dapeng2,3,4; Chi, Yihebali5; Chen, Xiaohong6; Ge, Minghua7,8,9,10; Zhang, Yuan11; Guo, Zhuming12; Wang, Jun13; Chen, Jie14; Zhang, Jiewu15; Cheng, Ying16
刊名CLINICAL CANCER RESEARCH
出版日期2021-07-01
卷号27
ISSN号1078-0432
DOI10.1158/1078-0432.CCR-20-2950
通讯作者Tang, Pingzhang(13683183575@163.com) ; Gao, Ming(gaoming68@aliyun.com)
英文摘要Purpose: Medullary thyroid cancer (MTC) accounts for about 2% of all thyroid cancer, but has a relatively poor prognosis compared with differentiated thyroid cancer. Anlotinib is a novel multitarget tyrosine kinase inhibitor targeting VEGFR, PDGFR, FGFR, and c-Kit. This multicenter, randomized, double-blind, placebo-controlled phase IIB study (ALTER 01031 and NCT02586350) was conducted to investigate the efficacy and safety of anlotinib in MTC. Patients and Methods: Patients with histopathologically confirmed, unresectable locally advanced or metastatic MTC were enrolled and randomly assigned in a 2:1 ratio to receive anlotinib (12 mg once daily from day 1 to 14 every 3 weeks) or placebo. Patients in placebo group were allowed to receive open-label anlotinib after disease progression. The primary endpoint was progression-free survival (PFS); secondary endpoints included objective response rate (ORR), disease control rate (DCR), and overall survival (OS). Results: Ninety-one patients were enrolled. At data cutoff date, the median PFS was significantly prolonged in the anlotinib group than in the placebo group (20.7 months vs. 11.1 months, P = 0.029; HR, 0.53; 95% confidence interval, 0.30-0.95). The ORR of anlotinib treatment was 48.4%. The incidence of treatment-related adverse events (TRAE) was 100% and 89.7% in the anlotinib and placebo groups, respectively. The most common TRAEs of all grades in the anlotinib group were palmar-plantar erythrodysesthesia syndrome (62.9%), protein uria (61.3%), and hypertriglyceridemia (48.4%). Conclusions: Anlotinib demonstrates its efficacy and safety in this phase IIB trial for the treatment of MTC and may become a new choice for this rare disease, especially for Chinese patients.
WOS关键词GROWTH-FACTOR ; VANDETANIB ; CANCER ; CABOZANTINIB ; SURVIVAL ; EFFICACY
资助项目Chia Tai TianQing Pharmaceutical Group Co., Ltd.
WOS研究方向Oncology
语种英语
WOS记录号WOS:000670550600011
出版者AMER ASSOC CANCER RESEARCH
资助机构Chia Tai TianQing Pharmaceutical Group Co., Ltd.
源URL[http://ir.hfcas.ac.cn:8080/handle/334002/123544]  
专题中国科学院合肥物质科学研究院
通讯作者Tang, Pingzhang; Gao, Ming
作者单位1.Zhengzhou Univ, Thyroid & Head & Neck Surg, Affiliated Canc Hosp, Zhengzhou, Peoples R China
2.Tianjin Med Univ Canc Inst & Hosp, Natl Clin Res Ctr Canc, Dept Thyroid & Neck Oncol, West Huan Hu Rd, Tianjin 300060, Peoples R China
3.Tianjins Clin Res Ctr Canc, West Huan Hu Rd, Tianjin 300060, Peoples R China
4.Key Lab Canc Prevent & Therapy, West Huan Hu Rd, Tianjin 300060, Peoples R China
5.Chinese Acad Med Sci & Peking Union Med Coll, Natl Canc Ctr, Dept Med Oncol, Natl Clin Res Ctr Canc,Canc Hosp, Beijing, Peoples R China
6.Capital Med Univ, Beijing Tongren Hosp, Beijing Inst Otolaryngol,Minist Educ, Dept Otolaryngol Head & Neck Surg,Key Lab Otolary, Beijing, Peoples R China
7.Chinese Acad Sci, Inst Canc & Basic Med ICBM, Head & Neck Surg, Hangzhou, Peoples R China
8.Univ Chinese Acad Sci, Canc Hosp, Zhejiang Canc Hosp, Hangzhou, Peoples R China
9.Zhejiang Prov Peoples Hosp, Head & Neck Surg, Hangzhou, Peoples R China
10.Hangzhou Med Coll, Peoples Hosp, Hangzhou, Peoples R China
推荐引用方式
GB/T 7714		 Li, Dapeng,Chi, Yihebali,Chen, Xiaohong,et al. Anlotinib in Locally Advanced or Metastatic Medullary Thyroid Carcinoma: A Randomized, Double-Blind Phase IIB Trial[J]. CLINICAL CANCER RESEARCH,2021,27.
APA Li, Dapeng.,Chi, Yihebali.,Chen, Xiaohong.,Ge, Minghua.,Zhang, Yuan.,...&Gao, Ming.(2021).Anlotinib in Locally Advanced or Metastatic Medullary Thyroid Carcinoma: A Randomized, Double-Blind Phase IIB Trial.CLINICAL CANCER RESEARCH,27.
MLA Li, Dapeng,et al."Anlotinib in Locally Advanced or Metastatic Medullary Thyroid Carcinoma: A Randomized, Double-Blind Phase IIB Trial".CLINICAL CANCER RESEARCH 27(2021).

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来源：合肥物质科学研究院

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