Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial -

Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial
Information type: Randomised controlled trials
Source: Lancet Public Health
Specialities: Cancers
Summary
This RCT (n=417) reported sorafenib improved PFS vs. placebo in patients with progressive radioactive iodine-refractory differentiated thyroid cancer (10.8 vs. 5.8 months, HR 0.59; 95% CI, 0.45-0.76;p<0.0001). Adverse events were consistent with known safety profile of sorafenib.
UKMi comment
This is the first phase III randomised, double-blind, placebo-controlled clinical trial with the sorafenib in differentiated thyroid cancer. On the basis of this trial, sorafenib received an orphan designation by the European Medicine Agency in differentiated thyroid cancer, and was approved by the FDA for treatment of radioactive iodine-refractory differentiated thyroid cancer in November, 2013.
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