scholarly journals Body Composition in Patients with Radioactive Iodine-Refractory, Advanced Differentiated Thyroid Cancer Treated with Sorafenib or Placebo: A Retrospective Analysis of the Phase III DECISION Trial

Thyroid ◽  
2019 ◽  
Vol 29 (12) ◽  
pp. 1820-1827 ◽  
Author(s):  
Olivier Huillard ◽  
Anne Jouinot ◽  
Camille Tlemsani ◽  
Marcia S. Brose ◽  
Jennifer Arrondeau ◽  
...  
Keyword(s):  
Body Composition ◽  
Thyroid Cancer ◽  
Retrospective Analysis ◽  
Differentiated Thyroid Cancer ◽  
Radioactive Iodine ◽  
Phase Iii ◽  
Decision Trial

Sorafenib in locally advanced or metastatic patients with radioactive iodine-refractory differentiated thyroid cancer: The phase III DECISION trial.

2013 ◽  
Vol 31 (18_suppl) ◽  
pp. 4-4 ◽  
Author(s):  
Marcia S. Brose ◽  
Christopher Nutting ◽  
Barbara Jarzab ◽  
Rossella Elisei ◽  
Salvatore Siena ◽  
...  
Keyword(s):  
Thyroid Cancer ◽  
Primary Endpoint ◽  
Differentiated Thyroid Cancer ◽  
Radioactive Iodine ◽  
Locally Advanced ◽  
Phase Iii ◽  
Open Label ◽  
Active Inhibitor ◽  
Phase Ii Studies ◽  
Decision Trial

4 Background: Sorafenib, an orally active inhibitor of VEGFR1-3 and Raf kinases, has shown promising clinical activity in single-arm phase II studies in radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC). The double-blind, randomized, multicenter phase III DECISION trial examined sorafenib efficacy and safety vs placebo in patients with progressive RAI-refractory DTC. Methods: Patients with locally advanced/metastatic RAI-refractory DTC who progressed in the preceding 14 months were randomized 1:1 to sorafenib 400 mg bid po or placebo. Placebo patients were allowed to receive sorafenib open-label upon progression. The primary endpoint was progression-free survival (PFS) assessed every 8 wks by independent radiologic review using modified RECIST 1.0 and analyzed by stratified log-rank statistics at α = 0.01 (one-sided). Secondary endpoints included overall survival (OS), response rate (RR; complete + partial response [PR]), and safety. Results: A total of 417 patients were randomized (207 to sorafenib and 210 to placebo); median age 63 yr, 52% female. Tumor histology by independent assessment was 57% papillary, 25% follicular, and 10% poorly differentiated. 96% of patients had metastatic disease; the most common target lesions were lung (71%), lymph node (40%), and bone (14%). The primary endpoint was met: median PFS 10.8 months (sorafenib) vs 5.8 months (placebo); HR 0.58, 95% CI 0.45–0.75, p<0.0001. Median OS has not been reached in either arm; 70% of placebo patients started open-label sorafenib. RR (all PRs) in the sorafenib vs placebo arms was 12.2% and 0.5% (p<0.0001) and stable disease ≥ 6 months was 42% and 33%, respectively. The most common any-grade treatment-emergent adverse events in the sorafenib arm included hand–foot skin reaction, diarrhea, alopecia, rash/desquamation, fatigue, weight loss and hypertension. One death in each arm was attributed to study drug. Conclusions: Sorafenib significantly improved PFS compared with placebo in patients with progressive RAI-refractory DTC. Tolerability was consistent with the known sorafenib safety profile. Clinical trial information: NCT00895674.

Sorafenib in locally advanced or metastatic patients with radioactive iodine-refractory differentiated thyroid cancer: The phase III DECISION trial.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4-4 ◽  
Author(s):  
Marcia S. Brose ◽  
Christopher Nutting ◽  
Barbara Jarzab ◽  
Rossella Elisei ◽  
Salvatore Siena ◽  
...  
Keyword(s):  
Thyroid Cancer ◽  
Annual Meeting ◽  
Differentiated Thyroid Cancer ◽  
Radioactive Iodine ◽  
Locally Advanced ◽  
Phase Iii ◽  
Daily News ◽  
Online Supplement ◽  
Decision Trial ◽  
Final Text

4 The full, final text of this abstract will be available at abstract.asco.org at 7:30 AM (EDT) on Sunday, June, 2, 2013, and in the Annual Meeting Proceedings online supplement to the June 20, 2013, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Sunday edition of ASCO Daily News.

scholarly journals Analysis of Biomarkers and Association With Clinical Outcomes in Patients With Differentiated Thyroid Cancer: Subanalysis of the Sorafenib Phase III DECISION Trial

2019 ◽  
Vol 25 (24) ◽  
pp. 7370-7380
Author(s):  
Marcia S. Brose ◽  
Martin Schlumbeger ◽  
Michael Jeffers ◽  
Christian Kappeler ◽  
Gerold Meinhardt ◽  
...  
Keyword(s):  
Thyroid Cancer ◽  
Clinical Outcomes ◽  
Differentiated Thyroid Cancer ◽  
Phase Iii ◽  
Decision Trial
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