Anlotinib in patients with medullary thyroid carcinoma with negative prognostic factors: A sub-analysis based on the ALTER01031 study
BackgroundMedullary thyroid carcinoma (MTC) is a rare type of thyroid cancer; however, it accounted for 13.4% of the disease-specific mortalities. ALTER01031 (NCT02586350) was a randomised, placebo-controlled phase 2b trial that evaluated the efficacy and safety of anlotinib in locally advanced or m...
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Frontiers Media S.A.
2022-11-01
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| Series: | Frontiers in Oncology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2022.852032/full |
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| author | Jingzhu Zhao Yihebali Chi Chuanxiang Hu Xiaohong Chen Minghua Ge Minghua Ge Yuan Zhang Zhuming Guo Jun Wang Jie Chen Jiewu Zhang Ying Cheng Zhendong Li Hui Liu Jianwu Qin Jingqiang Zhu Ruochuan Cheng Zhengang Xu Dapeng Li Pingzhang Tang Ming Gao Ming Gao Xiangqian Zheng |
| author_facet | Jingzhu Zhao Yihebali Chi Chuanxiang Hu Xiaohong Chen Minghua Ge Minghua Ge Yuan Zhang Zhuming Guo Jun Wang Jie Chen Jiewu Zhang Ying Cheng Zhendong Li Hui Liu Jianwu Qin Jingqiang Zhu Ruochuan Cheng Zhengang Xu Dapeng Li Pingzhang Tang Ming Gao Ming Gao Xiangqian Zheng |
| author_sort | Jingzhu Zhao |
| collection | DOAJ |
| description | BackgroundMedullary thyroid carcinoma (MTC) is a rare type of thyroid cancer; however, it accounted for 13.4% of the disease-specific mortalities. ALTER01031 (NCT02586350) was a randomised, placebo-controlled phase 2b trial that evaluated the efficacy and safety of anlotinib in locally advanced or metastatic MTC. This post hoc analysis aimed to evaluate the efficacy and safety of anlotinib in older patients and those with bone metastases using ALTER01031.MethodsIn ALTER01031, anlotinib significantly prolonged the median progression-free survival (PFS) from 11.1 months to 20.7 months compared with placebo in the whole population. Patients who were older (≥ 50 years) or had bone metastases were selected. PFS and overall survival (OS) were estimated and compared between patients receiving anlotinib or placebo in each subgroup. A sub-analysis of tumour response and safety was also performed.ResultsPatients with older age or bone metastases experienced rapid disease progression as the median PFS was 6.8 months and 7.0 months respectively in the placebo group. Anlotinib significantly improved the median PFS to 17.5 months (P = 0.002) and 20.7 months (P = 0.029) with hazard ratio (HR) of 0.31 (95% CI, 0.15–0.68) and 0.44 (95% CI, 0.20–0.94) compared with placebo. Significant benefit in OS was observed in patients with older age after a longer follow-up (HR = 0.47 [95% CI, 0.22–0.99], P = 0.041). The safety profile of these subgroups was similar to that of the entire population.ConclusionThis sub-analysis demonstrated significant survival benefits and favourable safety of anlotinib in patients with MTC who had old age or bone metastases, supporting the feasibility of anlotinib in these patients. |
| first_indexed | 2024-04-12T06:40:30Z |
| format | Article |
| id | doaj.art-71bbb6da655642cd96b735b8d222d403 |
| institution | Directory Open Access Journal |
| issn | 2234-943X |
| language | English |
| last_indexed | 2024-04-12T06:40:30Z |
| publishDate | 2022-11-01 |
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| series | Frontiers in Oncology |
| spelling | doaj.art-71bbb6da655642cd96b735b8d222d4032022-12-22T03:43:44ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2022-11-011210.3389/fonc.2022.852032852032Anlotinib in patients with medullary thyroid carcinoma with negative prognostic factors: A sub-analysis based on the ALTER01031 studyJingzhu Zhao0Yihebali Chi1Chuanxiang Hu2Xiaohong Chen3Minghua Ge4Minghua Ge5Yuan Zhang6Zhuming Guo7Jun Wang8Jie Chen9Jiewu Zhang10Ying Cheng11Zhendong Li12Hui Liu13Jianwu Qin14Jingqiang Zhu15Ruochuan Cheng16Zhengang Xu17Dapeng Li18Pingzhang Tang19Ming Gao20Ming Gao21Xiangqian Zheng22Department 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’s Clinical Research Center for Cancer, Tianjin, ChinaDepartment 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, ChinaDepartment 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’s Clinical Research Center for Cancer, Tianjin, ChinaDepartment of Otolaryngology Head and Neck Surgery, Beijing Tongren Hospital, Capital Medical University / Key Laboratory of Otolaryngology Head and Neck Surgery, Ministry of Education, Beijing Institute of Otolaryngology, Beijing, ChinaHead and Neck Surgery, Institute of Cancer and Basic Medicine (ICBM), Chinese Academy of Sciences; Cancer Hospital of the University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou, ChinaDepartment of Head, Neck and Thyroid Surgery, Zhejiang Provincial People’s Hospital, People’s Hospital of Hangzhou Medical College, Hangzhou, ChinaHead and Neck Surgery (Department), Jiangsu Cancer Hospital (Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital), Nanjing, ChinaHead and Neck Surgery, Sun Yat-sen University Cancer Center, Guangzhou, ChinaHead and Neck Surgery, Gansu Provincial Cancer Hospital, Lanzhou, ChinaHead and Neck Surgery Department I, Hunan Cancer Hospital, Changsha, China0Thyroid Surgery Ward, Harbin Medical University Cancer Hospital, Harbin, China1Department of Medical Oncology, Jilin Cancer Hospital, Changchun, China2Head and Neck Department, Tumor Hospital of China Medical University, Liaoning Tumor Hospital & Institute, Shenyang, China3Head and Neck Surgery, Fujian Cancer Hospital, Fuzhou, China4Thyroid & Head and Neck Surgery, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China5Thyroid Surgery, West China Hospital, Sichuan University, Chengdu, China6Department of Thyroid Surgery, First Affiliated Hospital of Kunming Medical University, Kunming, China7Head and Neck Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaDepartment 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’s Clinical Research Center for Cancer, Tianjin, China8Department for VIP, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaDepartment 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’s Clinical Research Center for Cancer, Tianjin, China9Breast & Thyroid Surgery, Tianjin Union Medical Center, Tianjin, ChinaDepartment 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’s Clinical Research Center for Cancer, Tianjin, ChinaBackgroundMedullary thyroid carcinoma (MTC) is a rare type of thyroid cancer; however, it accounted for 13.4% of the disease-specific mortalities. ALTER01031 (NCT02586350) was a randomised, placebo-controlled phase 2b trial that evaluated the efficacy and safety of anlotinib in locally advanced or metastatic MTC. This post hoc analysis aimed to evaluate the efficacy and safety of anlotinib in older patients and those with bone metastases using ALTER01031.MethodsIn ALTER01031, anlotinib significantly prolonged the median progression-free survival (PFS) from 11.1 months to 20.7 months compared with placebo in the whole population. Patients who were older (≥ 50 years) or had bone metastases were selected. PFS and overall survival (OS) were estimated and compared between patients receiving anlotinib or placebo in each subgroup. A sub-analysis of tumour response and safety was also performed.ResultsPatients with older age or bone metastases experienced rapid disease progression as the median PFS was 6.8 months and 7.0 months respectively in the placebo group. Anlotinib significantly improved the median PFS to 17.5 months (P = 0.002) and 20.7 months (P = 0.029) with hazard ratio (HR) of 0.31 (95% CI, 0.15–0.68) and 0.44 (95% CI, 0.20–0.94) compared with placebo. Significant benefit in OS was observed in patients with older age after a longer follow-up (HR = 0.47 [95% CI, 0.22–0.99], P = 0.041). The safety profile of these subgroups was similar to that of the entire population.ConclusionThis sub-analysis demonstrated significant survival benefits and favourable safety of anlotinib in patients with MTC who had old age or bone metastases, supporting the feasibility of anlotinib in these patients.https://www.frontiersin.org/articles/10.3389/fonc.2022.852032/fullmedullary thyroid carcinomaanlotinibsubgroup analysisolder agebone metastases |
| spellingShingle | Jingzhu Zhao Yihebali Chi Chuanxiang Hu Xiaohong Chen Minghua Ge Minghua Ge Yuan Zhang Zhuming Guo Jun Wang Jie Chen Jiewu Zhang Ying Cheng Zhendong Li Hui Liu Jianwu Qin Jingqiang Zhu Ruochuan Cheng Zhengang Xu Dapeng Li Pingzhang Tang Ming Gao Ming Gao Xiangqian Zheng Anlotinib in patients with medullary thyroid carcinoma with negative prognostic factors: A sub-analysis based on the ALTER01031 study Frontiers in Oncology medullary thyroid carcinoma anlotinib subgroup analysis older age bone metastases |
| title | Anlotinib in patients with medullary thyroid carcinoma with negative prognostic factors: A sub-analysis based on the ALTER01031 study |
| title_full | Anlotinib in patients with medullary thyroid carcinoma with negative prognostic factors: A sub-analysis based on the ALTER01031 study |
| title_fullStr | Anlotinib in patients with medullary thyroid carcinoma with negative prognostic factors: A sub-analysis based on the ALTER01031 study |
| title_full_unstemmed | Anlotinib in patients with medullary thyroid carcinoma with negative prognostic factors: A sub-analysis based on the ALTER01031 study |
| title_short | Anlotinib in patients with medullary thyroid carcinoma with negative prognostic factors: A sub-analysis based on the ALTER01031 study |
| title_sort | anlotinib in patients with medullary thyroid carcinoma with negative prognostic factors a sub analysis based on the alter01031 study |
| topic | medullary thyroid carcinoma anlotinib subgroup analysis older age bone metastases |
| url | https://www.frontiersin.org/articles/10.3389/fonc.2022.852032/full |
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