Yongkun Sun1, Feng Du2, Ming Gao3, Qinghai Ji4, Zhendong Li5, Yuan Zhang6, Zhuming Guo7, Jun Wang8, Xiangjin Chen9, Jinwan Wang1, Yihebali Chi1, Pingzhang Tang1. 1. 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, Beijing, China . 2. 2 Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), The VIPII Gastrointestinal Cancer Division of Medical Department, Peking University Cancer Hospital and Institute , Beijing, China . 3. 3 Department of Thyroid and Neck Oncology, Tianjin Medical University Cancer Institute and Hospital , Tianjin, China . 4. 4 Department of Head and Neck Surgery, Fudan University Shanghai Cancer Center, Shanghai, China . 5. 5 Department of Head and Neck Surgery, Liaoning Cancer Hospital and Institute , Shenyang, China . 6. 6 Department of Head and Neck Surgery, Jiangsu Cancer Hospital , Nanjing, China . 7. 7 Department of Head and Neck Surgery, Sun Yat-sen University Cancer Center , Guangzhou, China . 8. 8 Department of Thyroid and Breast Surgery, Gansu Provincial Cancer Hospital , Lanzhou, China . 9. 9 Department of Head and Neck Surgery, First Affiliated Hospital of Fujian Medical University , Fuzhou, China .
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.
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.
Authors: Tiandong Kong; Lu Chen; Xiaoli Zhao; Fangfang Duan; Hanli Zhou; Lei Wang; Danna Liu Journal: Invest New Drugs Date: 2022-07-05 Impact factor: 3.651