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

doi:10.1158/1078-0432.CCR-20-2950

	Anlotinib in Locally Advanced or Metastatic Medullary Thyroid Carcinoma: A Randomized, Double-Blind Phase IIB Trial
	Li, Dapeng 11,12,13; Chi, Yihebali 14; Chen, Xiaohong 15; Ge, Minghua 16,17,18,19; Zhang, Yuan 20; Guo, Zhuming 21; Wang, Jun 22; Chen, Jie 23; Zhang, Jiewu 24; Cheng, Ying 5
刊名	CLINICAL CANCER RESEARCH
	2021-07-01
卷号	27
ISSN号	1078-0432
DOI	10.1158/1078-0432.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.
资助项目	Chia Tai TianQing Pharmaceutical Group Co., Ltd.
WOS关键词	GROWTH-FACTOR ; VANDETANIB ; CANCER ; CABOZANTINIB ; SURVIVAL ; EFFICACY
WOS研究方向	Oncology
语种	英语
出版者	AMER ASSOC CANCER RESEARCH
WOS记录号	WOS:000670550600011
资助机构	Chia Tai TianQing Pharmaceutical Group Co., Ltd.
内容类型	期刊论文
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.Sichuan Univ, West China Hosp, Thyroid Surg, Chengdu, Peoples R China 2.Chinese Acad Med Sci & Peking Union Med Coll, Natl Canc Ctr, Head & Neck Surg, Natl Clin Res Ctr Canc,Canc Hosp, Beijing, Peoples R China 3.Chinese Acad Med Sci & Peking Union Med Coll, Natl Canc Ctr, Dept VIP, Natl Clin Res Ctr Canc,Canc Hosp, 17 Panjiayuan Nanli, Beijing 100021, Peoples R China 4.Tianjin Union Med Ctr, 190 Jieyuan Rd, Tianjin 300121, Peoples R China 5.Jilin Canc Hosp, Dept Med Oncol, Changchun, Peoples R China 6.China Med Univ, Liaoning Tumor Hosp & Inst, Dept Head & Neck Surg, Tumor Hosp, Shenyang, Peoples R China 7.Fujian Canc Hosp, Head & Neck Surg, Fuzhou, Peoples R China 8.Zhengzhou Univ, Thyroid & Head & Neck Surg, Affiliated Canc Hosp, Zhengzhou, Peoples R China 9.Henan Canc Hosp, Zhengzhou, Peoples R China 10.Kunming Med Univ, Dept Thyroid Surg, Affiliated Hosp 1, Kunming, Yunnan, 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).