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, 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
Abstract
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 NCT01728623.
Keywords: anaplastic; lenvatinib; medullary; radioiodine-refractory differentiated thyroid cancer; thyroid carcinoma.
Source: PubMed