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Proffered paper and Mini oral mixed session on Head and neck

265O - Anlotinib in locally advanced or metastatic radioiodine-refractory differentiated thyroid carcinoma: A randomized, double-blind, multicenter phase II trial

Date

21 Nov 2020

Session

Proffered paper and Mini oral mixed session on Head and neck

Presenters

Yihebali Chi

Citation

Annals of Oncology (2020) 31 (suppl_6): S1347-S1354. 10.1016/annonc/annonc360

Authors

Y. Chi1, M. Gao2, Y. Zhang3, F. Shi4, Y. Cheng5, Z. Guo6, M. Ge7, J. Qin8, J. Zhang9, Z. Li10, X. Zhou11, R. Huang12, X. Chen13, H. Liu14, R. Cheng15, Z. Xu16, X. Zheng2, D. Li2, P. Tang17

Author affiliations

  • 1 Department Of Medical Oncology, National Cancer Center / National Clinical Research Center for Cancer / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 100021 - Beijing/CN
  • 2 Department Of Thyroid And Neck Oncology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer; Key Laboratory of Cancer Prevention and Therapy, Tianjin; Tianjin’s Clinical Research Center for Cancer, Tianjin/CN
  • 3 Head And Neck Surgery (department), Jiangsu Cancer Hospital (Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital), Nanjing/CN
  • 4 Thyroid Tumour Internal Medicine Department / Nuclear Medicine Center, Hunan Cancer Hospital, Changsha/CN
  • 5 Department Of Medical Oncology, Jilin Cancer Hospital, Changchun/CN
  • 6 Head And Neck Surgery, Sun Yat-sen University Cancer Center, Guangzhou/CN
  • 7 Department Of Head, Neck And Thyroid Surgery, Zhejiang Provincial People's Hospital; People's Hospital of Hangzhou Medical College, Hangzhou/CN
  • 8 Thyroid & Head And Neck Surgery, Affiliated Cancer Hospital of Zhengzhou University; Henan Cancer Hospital, Henan/CN
  • 9 Thyroid Surgery Ward, Harbin Medical University Cancer Hospital, Harbin/CN
  • 10 Department Of Head &neck Surgery, Tumor Hospital of China Medical University, Liaoning Tumor Hospital & Institute, Shenyang/CN
  • 11 Head And Neck Cancer Center, Chongqing University Cancer Hospital, Chongqing Cancer Hospital, Chongqing/CN
  • 12 Department Of Nuclear Medicine, West China Hospital, Sichuan University, Sichuan/CN
  • 13 Department Of Otolaryngology Head And Neck Surgery, Beijing Tongren Hospital, Capital Medical University, Beijing/CN
  • 14 Head And Neck Department, Fujian Cancer Hospital, Fuzhou/CN
  • 15 Department Of Thyroid Surgery, First Affiliated Hospital of Kunming Medical University, Kunming/CN
  • 16 Head And Neck Surgery, National Cancer Center / National Clinical Research Center for Cancer / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 100021 - Beijing/CN
  • 17 Department For Vip, National Cancer Center / National Clinical Research Center for Cancer / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 100021 - Beijing/CN
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Resources

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Abstract 265O

Background

Anlotinib is a novel multikinase inhibitor targeting VEGFR, PDGFR, FGFR, and c-Kit. This study investigated the potency of anlotinib in treating locally advanced or metastatic radioiodine-refractory differentiated thyroid carcinoma (RAIR-DTC).

Methods

This is a randomized, double-blind, placebo-controlled, multicenter phase II trial (NCT02586337). Eligible pts were 18-70 years old with measurable, pathologically confirmed locally advanced or metastatic RAIR-DTC. Pts who had received previous anlotinib or other VEGFR-TKIs were excluded. Pts were randomized in a 2:1 ratio to receive anlotinib or placebo with a dose of 12mg QD for 2 weeks followed by a week of rest (2/1 schedule). The primary endpoint was progression-free survival (PFS). The secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety. Pts in placebo arm were allowed to receive open-label anlotinib after disease progression.

Results

Between September 2015 and August 2018, 113 pts (76 in anlotinib arm and 37 in placebo arm) were enrolled. The data cutoff date for primary endpoint was January 1, 2020. The research met its primary endpoint that the median PFS was 40.54 months (95% CI 28.29, NE) in anlotinib arm and 8.38 months (95% CI 5.59, 13.80) in placebo arm (p < 0.0001). The HR was 0.21 (95% CI 0.12, 0.37). The ORR was 59.21% in anlotinib arm and no response was observed in placebo arm (p < 0.0001). In addition, significant DCR benefit was observed for anlotinib treatment (anlotinib arm vs. placebo arm = 97.37% vs. 78.38%, p = 0.002). The OS data was still in follow-up. All pts in anlotinib arm and 97.30% pts in placebo arm experienced adverse events (p = 0.327). The incidence of treatment-related AEs of two groups was 100.00% and 86.49% (p = 0.003). Serious treatment-related AEs occurred in 15.79% pts received anlotinib. The most common AEs in anlotinib arm were hypertension (84.21%) and hypertriglyceridemia (68.42%).

Conclusions

The study demonstrates the efficacy and safety of anlotinib and supports its use as a new option for the treatment of locally advanced or metastatic RAIR-DTC.

Clinical trial identification

NCT02586337.

Editorial acknowledgement

Legal entity responsible for the study

Chia Tai TianQing Pharmaceutical Group Co., Ltd.

Funding

Chia Tai TianQing Pharmaceutical Group Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.

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