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Updated: Oct 26, 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
A Randomized, Phase III Study of Lenvatinib in Chinese Patients with Radioiodine-Refractory Differentiated Thyroid
Xiangqian Zheng1, Zhengang Xu2, Qinghai Ji3
1Department of Thyroid and Neck Tumor, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, China.
Purpose:
Lenvatinib has shown efficacy in treating radioiodine-refractory differentiated thyroid cancer (RR-DTC) in the multinational phase III SELECT study; however, it has not been tested in Chinese patients with RR-DTC.
Patients And Methods:
Chinese patients with confirmed RR-DTC (n = 151) were randomly assigned 2:1 to receive lenvatinib 24 mg/day or placebo in 28-day cycles. The primary endpoint was progression-free survival, and key secondary endpoints included objective response rate and safety. Analyses for progression-free survival and objective response rate were conducted using Response Evaluation Criteria in Solid Tumors v1.1 and confirmed by independent imaging review. All adverse events were assessed and monitored.
Results:
Progression-free survival was significantly longer with lenvatinib treatment [n = 103; median 23.9 months; 95% confidence interval (CI), 12.9-not estimable] versus placebo (n = 48; median 3.7 months; 95% CI, 1.9-5.6; hazard ratio = 0.16; 95% CI, 0.10-0.26; P < 0.0001). The objective response rate was 69.9% (95% CI, 61.0-78.8) in the lenvatinib arm and 0% (95% CI, 0-0) in the placebo arm. At data cutoff, 60.2% of patients receiving lenvatinib remained on treatment; treatment-emergent adverse events led to lenvatinib discontinuation in 8.7% of patients. Overall, treatment-emergent adverse events of grade ≥3 occurred in 87.4% of patients in the lenvatinib arm, the most common being hypertension (62.1%) and proteinuria (23.3%).
Conclusions:
Lenvatinib at a starting dose of 24 mg/day significantly improved progression-free survival and objective response rate in Chinese patients with RR-DTC versus placebo. There were no new or unexpected toxicities. Results are consistent with those from SELECT involving patients with RR-DTC.
Insights
Lenvatinib significantly improved progression-free survival and response rates in Chinese patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC). The drug demonstrated a favorable safety profile, consistent with previous studies.
Area of Science:
- Oncology
- Pharmacology
Background:
- Radioiodine-refractory differentiated thyroid cancer (RR-DTC) presents a therapeutic challenge.
- Lenvatinib has demonstrated efficacy in RR-DTC in multinational studies.
Purpose of the Study:
- To evaluate the efficacy and safety of lenvatinib in Chinese patients with RR-DTC.
- To compare lenvatinib versus placebo in this specific patient population.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 151 Chinese patients with RR-DTC.
- Patients received lenvatinib (24 mg/day) or placebo in 28-day cycles.
- Primary endpoint was progression-free survival; secondary endpoints included objective response rate and safety.
Main Results:
- Lenvatinib significantly prolonged progression-free survival (median 23.9 months vs. 3.7 months; P < 0.0001).
- Objective response rate was 69.9% with lenvatinib versus 0% with placebo.
- Grade ≥3 treatment-emergent adverse events occurred in 87.4% of lenvatinib recipients, most commonly hypertension and proteinuria.
Conclusions:
- Lenvatinib (24 mg/day) significantly improves progression-free survival and objective response rate in Chinese patients with RR-DTC.
- The safety profile was consistent with prior studies, with no new unexpected toxicities observed.
