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Updated: Jul 17, 2026
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Establishment and Characterization of Patient-Derived Xenograft Models of Anaplastic Thyroid Carcinoma and Head and Neck Squamous Cell Carcinoma
Published on: June 2, 2023
Development of a sensitive plasma lenvatinib quantification method and validation in thyroid cancer patients
Carla Colombo1,2, Roberta Ottria3, Matteo Trevisan4,5
1Department of Endocrine and Metabolic Diseases, IRCCS Istituto Auxologico Italiano, 20145 Milan, Italy.
Journal of the Endocrine Society
|July 16, 2026
Summary
This study found significant variability in Lenvatinib (LEN) plasma concentrations among patients with differentiated thyroid cancer (DTC). Interindividual differences, not just dose, influence LEN levels and potential toxicity in real-world settings.
Area of Science:
- Pharmacokinetics
- Oncology
- Analytical Chemistry
Background:
- Lenvatinib (LEN) is effective for differentiated thyroid cancer (DTC) but causes adverse events (AEs).
- The dose-dependency of LEN toxicity is not well understood due to limited data.
Purpose of the Study:
- To investigate the relationship between Lenvatinib dose and plasma concentrations in DTC patients.
- To evaluate interindividual pharmacokinetic variability of Lenvatinib in a real-world setting.
Main Methods:
- Developed and validated a high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) assay for Lenvatinib quantification in plasma.
- Analyzed plasma samples from 19 patients with metastatic, radioactive iodine-refractory DTC.
Main Results:
- A positive correlation was observed between Lenvatinib dose and plasma concentrations, especially at lower doses (<18 mg/day).
- Significant interindividual variability in plasma Lenvatinib concentrations was identified (17%-28% of total variance).
- Variability was more pronounced at higher doses (≥18 mg/day), potentially linked to AEs rather than direct dose-dependency.
Conclusions:
- This is the first real-world evaluation of Lenvatinib pharmacokinetic variability in advanced DTC using a novel HPLC-MS/MS method.
- The Lenvatinib dose-response relationship in DTC appears complex, with significant interpatient variability.
- Further research is needed to clarify the clinical implications of these findings for patient management.
