Gupta-Abramson V et al. - This study demonstrates that sorafenib has clinically relevant antitumor activity in patients with metastatic, iodine-refractory thyroid carcinoma with an overall acceptable safety profile. Methods
An open-label phase II trial to determine the efficacy of sorafenib in pts with advanced thyroid carcinoma
Eligible pts with metastatic, iodine-refractory thyroid carcinoma received sorafenib 400 mg orally twice daily
Responses were measured radiographically every 2 to 3 mos
The study end points included RR, PFS, and best response by Response Evaluation Criteria in Solid Tumors
Results
30 pts were treated for a minimum of 16 wks
23% of pts had a PR lasting 18+ to 84 wks
53% of pts had SD lasting 14 to 89+ wks
95% of pts for whom serial thyroglobulin levels were available showed a rapid decrease by 70%
The median PFS was 79 wks
Toxicity was consistent with other sorafenib trials
Only a single patient died of liver failure that was likely treatment related