A Phase II study of the safety and efficacy of lenvatinib in patients with advanced thyroid cancer

Shunji Takahashi, Naomi Kiyota, Tomoko Yamazaki, Naoko Chayahara, Kenji Nakano, Lina Inagaki, Kazuhisa Toda, Tomohiro Enokida, Hironobu Minami, Yoshinori Imamura, Naoki Fukuda, Tatsuya Sasaki, Takuya Suzuki, Hiroki Ikezawa, Corina E. Dutcus, Makoto Tahara

Research output: Contribution to journalArticlepeer-review

93 Scopus citations


Aim: To investigate the safety and efficacy of lenvatinib in advanced thyroid cancer. Patients/methods: 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 24 mg. The primary end point was safety. Results: 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: 25.8 months; MTC: 9.2 months; ATC: 7.4 months. Conclusion: Lenvatinib demonstrated a manageable safety profile, proven antitumor activity in RR-DTC and promising efficacy in MTC and ATC. Clinical trial registration: clinicaltrials.gov NCT0172862.

Original languageEnglish
Pages (from-to)717-726
Number of pages10
JournalFuture Oncology
Issue number7
StatePublished - Mar 2019
Externally publishedYes


  • anaplastic
  • lenvatinib
  • medullary
  • radioiodine-refractory differentiated thyroid cancer
  • thyroid carcinoma


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