Abstract
To investigate the safety and efficacy of lenvatinib in advanced thyroid cancer. In this Phase II study, 51 Japanese patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC), medullary thyroid cancer (MTC)or anaplastic thyroid cancer (ATC) received once-daily lenvatinib 24mg. The primary end point was safety. All patients experienced ≥1 adverse event (AE); only one patient experienced an AE leading to discontinuation. The most common any-grade AEs were hypertension, decreased appetite, palmar-plantar erythrodysesthesia, fatigue and proteinuria. Response rates for RR-DTC: 68%; MTC: 22%; ATC: 24%. Median progression-free survival for RR-DTC: 25.8months; MTC: 9.2 months; ATC: 7.4 months. Lenvatinib demonstrated a manageable safety profile, proven antitumor activity in RR-DTC and promising efficacy in MTC and ATC. clinicaltrials.gov NCT01728623.
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