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

Author:

Takahashi Shunji1,Kiyota Naomi2,Yamazaki Tomoko3,Chayahara Naoko2,Nakano Kenji1,Inagaki Lina1,Toda Kazuhisa4,Enokida Tomohiro5,Minami Hironobu2,Imamura Yoshinori2,Fukuda Naoki1,Sasaki Tatsuya6,Suzuki Takuya6,Ikezawa Hiroki6,Dutcus Corina E7,Tahara Makoto5

Affiliation:

1. Department of Medical Oncology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan

2. Department of Medical Oncology & Hematology/Cancer Center, Kobe University Hospital, Kobe, Japan

3. Department of Head & Neck Oncology, Miyagi Cancer Center, Miyagi, Japan

4. Department of Head & Neck Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan

5. Department of Head & Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan

6. Eisai Co. Ltd, Tokyo, Japan

7. Eisai Inc., Woodcliff Lake, NJ 07677, USA

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

Publisher

Future Medicine Ltd

Subject

Cancer Research,Oncology,General Medicine

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