Anlotinib for the treatment of patients with locally advanced or metastatic medullary thyroid cancer

Yongkun Sun, Feng Du, Ming Gao, Qinghai Ji, Zhendong Li, Yuan Zhang, Zhuming Guo, Jun Wang, Xiangjin Chen, Jinwan Wang, Yihebali Chi, Pingzhang Tang

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Background: The prognosis of advanced or metastatic medullary thyroid carcinoma (MTC) is poor, and there are few therapeutic options. Anlotinib has previously shown promising antitumor activity on MTC in preclinical models and a Phase I study. This Phase II clinical trial was devised to confirm the antitumor activity of anlotinib in patients with advanced or metastatic MTC. Methods: Patients with unresectable locally advanced or metastatic MTC received once daily oral anlotinib 12 mg, two weeks on/one week off, until disease progression, death, unacceptable toxicity, or withdrawal of consent for any reason. The dose was adjusted on the basis of observed toxicity. The primary endpoint was progression-free survival (PFS). Results: Fifty-eight patients received anlotinib treatment. The primary endpoint PFS has not yet been reached at the time of analysis. On the basis of investigator assessments, 56.9% of patients experienced a partial response. PFS rate at 48 weeks was 85.5%. Forty-five patients had a ≥50% decrease in serum calcitonin concentration from baseline. The most common adverse events were hand-foot syndrome, hypertriglyceridemia, cholesterol elevation, fatigue, and proteinuria. Conclusions: Anlotinib demonstrated a durable antitumor activity with a manageable adverse event profile in locally advanced or metastatic MTC.

Original languageEnglish (US)
Pages (from-to)1455-1461
Number of pages7
JournalThyroid
Volume28
Issue number11
DOIs
StatePublished - Nov 2018

Fingerprint

Disease-Free Survival
Hand-Foot Syndrome
Therapeutics
Phase II Clinical Trials
Hypertriglyceridemia
Calcitonin
Proteinuria
Fatigue
Disease Progression
Survival Rate
Cholesterol
Research Personnel
Medullary Thyroid cancer
Serum

Keywords

  • anlotinib
  • clinical trial
  • medullary thyroid carcinoma

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Anlotinib for the treatment of patients with locally advanced or metastatic medullary thyroid cancer. / Sun, Yongkun; Du, Feng; Gao, Ming; Ji, Qinghai; Li, Zhendong; Zhang, Yuan; Guo, Zhuming; Wang, Jun; Chen, Xiangjin; Wang, Jinwan; Chi, Yihebali; Tang, Pingzhang.

In: Thyroid, Vol. 28, No. 11, 11.2018, p. 1455-1461.

Research output: Contribution to journalArticle

Sun, Y, Du, F, Gao, M, Ji, Q, Li, Z, Zhang, Y, Guo, Z, Wang, J, Chen, X, Wang, J, Chi, Y & Tang, P 2018, 'Anlotinib for the treatment of patients with locally advanced or metastatic medullary thyroid cancer', Thyroid, vol. 28, no. 11, pp. 1455-1461. https://doi.org/10.1089/thy.2018.0022
Sun, Yongkun ; Du, Feng ; Gao, Ming ; Ji, Qinghai ; Li, Zhendong ; Zhang, Yuan ; Guo, Zhuming ; Wang, Jun ; Chen, Xiangjin ; Wang, Jinwan ; Chi, Yihebali ; Tang, Pingzhang. / Anlotinib for the treatment of patients with locally advanced or metastatic medullary thyroid cancer. In: Thyroid. 2018 ; Vol. 28, No. 11. pp. 1455-1461.
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AU - Guo, Zhuming

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AB - Background: The prognosis of advanced or metastatic medullary thyroid carcinoma (MTC) is poor, and there are few therapeutic options. Anlotinib has previously shown promising antitumor activity on MTC in preclinical models and a Phase I study. This Phase II clinical trial was devised to confirm the antitumor activity of anlotinib in patients with advanced or metastatic MTC. Methods: Patients with unresectable locally advanced or metastatic MTC received once daily oral anlotinib 12 mg, two weeks on/one week off, until disease progression, death, unacceptable toxicity, or withdrawal of consent for any reason. The dose was adjusted on the basis of observed toxicity. The primary endpoint was progression-free survival (PFS). Results: Fifty-eight patients received anlotinib treatment. The primary endpoint PFS has not yet been reached at the time of analysis. On the basis of investigator assessments, 56.9% of patients experienced a partial response. PFS rate at 48 weeks was 85.5%. Forty-five patients had a ≥50% decrease in serum calcitonin concentration from baseline. The most common adverse events were hand-foot syndrome, hypertriglyceridemia, cholesterol elevation, fatigue, and proteinuria. Conclusions: Anlotinib demonstrated a durable antitumor activity with a manageable adverse event profile in locally advanced or metastatic MTC.

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