Open-Label, Single-Arm, Multicenter, Phase II Trial of Lenvatinib for the Treatment of Patients With Anaplastic Thyroid Cancer.

Authors

• Lori J Wirth
• Marcia S Brose
• Eric J Sherman
• Lisa Licitra
• Martin Schlumberger
• Steven I Sherman
• Keith C Bible
• Bruce Robinson
• Patrice Rodien
• Yann Godbert
• Christelle De La Fouchardiere
• Kate Newbold
• Christopher Nutting
• Soamnauth Misir
• Ran Xie
• Ana Almonte
• Weifei Ye
• Maria E Cabanillas

Publication/Presentation Date

7-20-2021

Abstract

PURPOSE: Anaplastic thyroid cancer (ATC), an aggressive malignancy, is associated with a poor prognosis and an unmet need for effective treatment, especially for patients without

METHODS: This open-label, multicenter, international, phase II study enrolled patients with ATC, who had ≥ 1 measurable target lesion, to receive lenvatinib 24 mg once daily. The primary end points were objective response rate (ORR) by investigator assessment per RECIST v1.1 and safety. Responses were confirmed ≥ 4 weeks after the initial response. Additional end points included progression-free survival and overall survival (OS).

RESULTS: The study was halted for futility as the minimum ORR threshold of 15% was not met upon interim analysis. The interim analysis set included the first 20 patients. The full analysis set includes all 34 enrolled and treated patients. In the full analysis set, one patient achieved a partial response (ORR, 2.9%; 95% CI, 0.1 to 15.3). More than half of the evaluable patients experienced tumor shrinkage; three patients experienced a > 30% tumor reduction. The median progression-free survival was 2.6 months (95% CI, 1.4 to 2.8); the median overall survival was 3.2 months (95% CI, 2.8 to 8.2). The most common treatment-related adverse events (AEs) were hypertension (56%), decreased appetite (29%), fatigue (29%), and stomatitis (29%). No major treatment-related bleeding events or grade 5 treatment-related AEs occurred.

CONCLUSION: The safety profile of lenvatinib in ATC was manageable, and many AEs were attributable to the progression of ATC. The results suggest that lenvatinib monotherapy may not be an effective treatment for ATC; further investigation may be warranted.

Volume

39

Issue

21

First Page

2359

Last Page

2366

ISSN

1527-7755

Published In/Presented At

Wirth, L. J., Brose, M. S., Sherman, E. J., Licitra, L., Schlumberger, M., Sherman, S. I., Bible, K. C., Robinson, B., Rodien, P., Godbert, Y., De La Fouchardiere, C., Newbold, K., Nutting, C., Misir, S., Xie, R., Almonte, A., Ye, W., & Cabanillas, M. E. (2021). Open-Label, Single-Arm, Multicenter, Phase II Trial of Lenvatinib for the Treatment of Patients With Anaplastic Thyroid Cancer. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 39(21), 2359–2366. https://doi.org/10.1200/JCO.20.03093

Disciplines

Medicine and Health Sciences

PubMedID

33961488

Department(s)

Hematology-Medical Oncology Division

Document Type

Article