LN is an oral, multikinase inhibitor that significantly prolonged median progression-free survival vs placebo (PB) in a phase 3 study of patients (pts) 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
Pts with RR-DTC in this double-blind, multicenter study were randomized 2:1 to LN or PB (24mg/d; 28-d cycle). Tumor assessments in specific metastasis sites were evaluated by independent radiologic review using the Response Evaluation Criteria in Solid Tumors v1.1 at baseline and 8-week intervals. Sites evaluated were lung, liver, lymph nodes, and bone.
Following LN treatment, pts showed tumor shrinkage in all targeted sites compared with baseline (Table 1). The mean maximum change in sum of target lesions (in mm; see table) from baseline was significantly greater in pts treated with LN vs PB in the lungs (–15.1 vs 1.4), liver (–17.7 vs 2.5), lymph nodes (–17.4 vs –0.8), and bone (–6.7 vs 3.4). In pts treated with LN vs PB, a greater percent change from baseline (%) was observed in the lung (–45.9 vs 2.7), liver (–35.6 vs 5.1), lymph nodes (–47.5 vs 2.9), and bone (–10.7 vs 6.5). In the LN 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 pts with lung, liver, lymph node, and bone metastases, respectively.
In targeted metastasis sites, greater tumor shrinkage was observed following LN treatment vs PB. These data provide additional evidence of the clinical benefit of LN in the treatment of RR-DTC, particularly in pts with specific metastases, although responses are also seen in bone metastases.
Clinical trial identification
Legal entity responsible for the study
B. Robinson: Advisory Board member for Eisai, Astra Zeneca, Bayer and has served as a board member for MaynePharma. M. Schlumberger: Received grants and personal fees from Eisai Inc. L.J. Wirth: Served as an advisory board member for Eisai and Loxo and has consulted for Eisai and Ashion. C.E. Dutcus: Employee of Eisai Inc. T.A. Binder, M. Guo: Employee of Eisai Inc. M. Taylor: Served as an advisory board consultant for Eisai and ONYX. M.K. Krzyzanowska: Served as an advisory board member for Eisai and Bayer, and has received research funding (site PI for clinical trials) for Eisai, Astra Zeneca, Exelixis, and Novartis. J. Capdevilla: Served as an advisory board member for Eisai, Bayer, Astra Zeneca, and received research funding for Eisai, Bayer, and Astra Zeneca. S.I. Sherman: Served as an advisory board member for Eisai and Veracyte, has consulted for Exelixis and Rosetta Genomics, and has received research funding from Genzyme. M. Tahara: Received grants, research support, and honoraria from Eisai Inc.; received grants and personal fees from Merck Sharpe & Dohme; and received personal fees from Merck Serono, Bristol Myer Squibb, Otsuka, and Bayer. All other authors have declared no conflicts of interest.