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FDA Update: Thyrotropin Approved For Thyroid Cancer Ablation
Tracy Hampton, PhD, MDLinx Oncology
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Article Summary

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Phase II trial of sorafenib in advanced thyroid cancer
Journal of Clinical Oncology, 06/17/08
Print     Email This Article     Save in My Library   Free Abstract
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

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