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Updated: Aug 18, 2025
Establishment and Characterization of Patient-Derived Xenograft Models of Anaplastic Thyroid Carcinoma and Head and Neck Squamous Cell Carcinoma
Published on: June 2, 2023
Anlotinib in patients with medullary thyroid carcinoma with negative prognostic factors: A sub-analysis based on the
Jingzhu Zhao1, Yihebali Chi2, Chuanxiang Hu1
1Department 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, China.
Background:
Medullary 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.
Methods:
In 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.
Results:
Patients 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.
Conclusion:
This 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.
Insights
Anlotinib significantly improved progression-free survival in older patients and those with bone metastases suffering from medullary thyroid carcinoma (MTC). This study supports anlotinib
Area of Science:
- Oncology
- Clinical Trials
- Pharmacology
Background:
- Medullary thyroid carcinoma (MTC) is a rare but fatal cancer.
- Anlotinib was evaluated in a phase 2b trial (ALTER01031) for advanced MTC.
Purpose of the Study:
- To assess anlotinib's efficacy and safety in older MTC patients (≥ 50 years).
- To evaluate anlotinib's efficacy and safety in MTC patients with bone metastases.
Main Methods:
- A post-hoc analysis of the randomized, placebo-controlled ALTER01031 trial.
- Compared progression-free survival (PFS) and overall survival (OS) between anlotinib and placebo groups in subgroups.
Main Results:
- Anlotinib significantly improved median PFS in older patients (17.5 vs. 6.8 months) and those with bone metastases (20.7 vs. 7.0 months).
- Anlotinib also demonstrated a significant overall survival benefit in older patients.
- The safety profile in these subgroups was consistent with the overall trial population.
Conclusions:
- Anlotinib offers significant survival benefits for MTC patients with old age or bone metastases.
- Anlotinib shows a favorable safety profile, supporting its use in these specific MTC patient populations.
