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Updated: May 22, 2026

Establishment and Characterization of Patient-Derived Xenograft Models of Anaplastic Thyroid Carcinoma and Head and Neck Squamous Cell Carcinoma
Published on: June 2, 2023
Off-label use of sunitinib in patients with advanced, epithelial thyroid cancer: a retrospective analysis
Giuseppe Pasqualetti1, Sergio Ricci, Giuseppe Boni
1Geriatrics Unit, Department of Internal Medicine, University of Pisa, Via Roma 67, 56126 Pisa, Italy.
Abstract:
Tyrosine kinase receptors play an important role in tumor angiogenesis and, their implication in epithelial thyroid tumor growth has been highlighted. Sunitinib is a novel tyrosine kinase inhibitor, approved in 2006 by Food and Drug Administration for the treatment of advanced renal cell and gastrointestinal stromal tumors. Preliminary promising results have been also obtained in patients with RAI-resistant thyroid neoplasia. In the current study, our experience on 9 patients with advanced thyroid epithelial cancer is analyzed and discussed in relation to the new patents in this field. According to RECIST criteria, partial response was obtained in 5/9 (55.5%) patients at 3 months and in 6/9 (66.6%) at 6 months. Median treatment follow-up was 13.0 months and median overall survival and progression-free survival were 20 [95% confidence interval (CI) 9.3 - 30.6] and 21 months (95% CI 6.9 - 35.1), respectively. One case of severe thoracic hemorrhage was observed, the most common adverse events being represented by fatigue, (44.4% ), skin rash (33.3% ), headache (33.3% ), and one case each of hypertension, macrocytosis and acute pneumonia. These results confirm sunitinib as a potential useful tool for the treatment of advanced thyroid cancers and may open the way for new patents of molecules with more specific target selectivity.
Insights
Sunitinib shows promise in treating advanced thyroid cancer, with over half of patients experiencing partial response. This tyrosine kinase inhibitor offers a potential new avenue for managing this aggressive disease.
Area of Science:
- Oncology
- Pharmacology
Background:
- Tyrosine kinase receptors are crucial in tumor angiogenesis and epithelial thyroid cancer growth.
- Sunitinib, a tyrosine kinase inhibitor, is FDA-approved for advanced renal cell and gastrointestinal stromal tumors.
- Preliminary data suggests sunitinib efficacy in radioiodine-refractory thyroid cancer.
Purpose of the Study:
- To analyze the efficacy and safety of sunitinib in patients with advanced thyroid epithelial cancer.
- To discuss current findings in the context of emerging patents for thyroid cancer therapeutics.
Main Methods:
- Retrospective analysis of 9 patients with advanced thyroid epithelial cancer treated with sunitinib.
- Evaluation of treatment response using RECIST criteria.
- Assessment of overall survival, progression-free survival, and adverse events.
Main Results:
- Partial response observed in 55.5% of patients at 3 months and 66.6% at 6 months.
- Median overall survival was 20 months and median progression-free survival was 21 months.
- Common adverse events included fatigue, skin rash, and headache; one severe case of thoracic hemorrhage occurred.
Conclusions:
- Sunitinib demonstrates potential as a treatment for advanced thyroid cancers.
- These findings may stimulate the development of new, more targeted therapies for thyroid cancer.
- Further research into sunitinib and similar agents is warranted for refractory thyroid neoplasia.

