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Open-label, single-arm, multicenter, phase II trial of lenvatinib for the treatment of patients with anaplastic thyroid cancer

Journal of Clinical Oncology May 12, 2021

Wirth LJ, Brose MS, Sherman EJ, et al. - Given lenvatinib (a US Food and Drug Administration–approved agent for radioiodine-refractory differentiated thyroid cancer) has previously shown activity in a small study of patients with anaplastic thyroid cancer (ATC) (n = 17), researchers further assessed lenvatinib in ATC by conducting this open-label, multicenter, international, phase II study. Participants had ATC and ≥ 1 measurable target lesion. They were treated with lenvatinib 24 mg once daily. Because the minimum objective response rate threshold of 15% was not met upon interim analysis, thus, the study was discontinued for futility. There were all 34 enrolled and treated patients in the full analysis. A partial response was seen in one patient in the full analysis set. A median progression-free survival of 2.6 months and median overall survival of 3.2 months was reported. Findings demonstrated that a manageable safety profile was displayed by lenvatinib in ATC, and many adverse events were due to the progression of ATC. Based on findings, lenvatinib monotherapy may not represent an effective therapeutic choice for ATC.

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