Poster Presentation Joint 2016 COSA and ANZBCTG Annual Scientific Meeting

Responses in Specific Metastases Following Treatment With Lenvatinib: Results From the Phase 3 SELECT Trial (#264)

Bruce Robinson 1 , Martin Schlumberger 2 , Lori J. Wirth 3 , Corina Dutcus 4 , Terri Binder 4 , Matthew Guo 4 , Matthew H. Taylor 5 , Sung-Bae Kim 6 , Monika K. Krzyzanowska 7 , Jaume Capdevila 8 , Steven I. Sherman 9 , Louise Young 10 , Makoto Tahara 11
  1. Kolling Institute of Medical Research, The University of Sydney, Sydney, New South Wales, Australia
  2. Department of Nuclear Medicine and Endocrine Oncology, Gustave Roussy and University Paris-Sud, Villejuif, France
  3. Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, United States of America
  4. Eisai Inc., Woodcliff Lake, New Jersey, United States of America
  5. Knight Cancer Institute, Oregon Health and Science University, Portland, Oregon, United States of America
  6. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
  7. Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, Toronto, Ontario, United States of America
  8. Medical Oncology Department, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain
  9. Department of Endocrine Neoplasia and Hormonal Disorders, Division of Internal Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America
  10. Eisai Australia Pty Ltd, Melbourne, VIC, Australia
  11. Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan


Lenvatinib, a multikinase inhibitor, significantly prolonged median progression-free survival versus placebo in the phase 3 SELECT study of patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC; 18.3 vs 3.6 months; hazard ratio [HR]: 0.21; 99% confidence interval [CI]: 0.14–0.31; P<0.001). Because metastatic RR-DTC is associated with poor overall survival, this subanalysis examined response in specific metastasis sites.


Patients were randomized 2:1 to lenvatinib 24 mg/day or placebo. Tumor assessments in lung, liver, lymph nodes, and bone were evaluated by independent radiologic review using Response Evaluation Criteria in Solid Tumors version 1.1 at baseline and 8-week intervals.


Lenvatinib-treated patients showed tumor shrinkage in all targeted sites. Mean change in tumor size from baseline in mm for lenvatinib and placebo, respectively was 35.0 (n=199) and 36.5 (n=107) in lung, 47.6 (n=15) and 54.9 (n=12) in liver, –37.5 (n=126) and 39.8 (n=57) in lymph node, and 65.9 (n=41) and 63.1 (n=17) in bone metastases. Mean maximum percent change from baseline was –45.9% (n=189) for lenvatinib vs 2.7% (n=103) for placebo in lung (P < 0.0001), –35.6% (n=14) vs 5.1% (n=12) in liver (P < 0.0001), –47.5% (n=119) vs –2.9% (n=55) in lymph node (P < 0.0001), and –10.7% (n=34) vs 6.5% (n=16) in bone metastases (P < 0.01). In the lenvatinib arm, median duration of objective response was not estimable (NE; 95% CI: 16.6–NE; n=139), 7.3 (1.9–NE; n=7), 16.8 (95% CI 12.9–NE; n=84), and 12.9 (95% CI 3.6–NE; n=10) months for patients with lung, liver, lymph node, and bone metastases, respectively.


In targeted metastasis sites, greater tumor shrinkage was observed following lenvatinib treatment versus placebo. These data provide additional evidence for the clinical benefit of lenvatinib treatment for RR-DTC, particularly in patients with specific metastases, although responses are also observed in patients with bone metastases.