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DECISION Trial Supports Sorafenib in Thyroid Cancer

Insights From: Robert I. Haddad, MD, Dana-Farber; Matthew H. Taylor, MD, Oregon Health;R. Michael Tuttle, MD, MSKCC
Published: Wednesday, May 06, 2015
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Based on results from the DECISION trial, the oral TKI sorafenib became the first FDA-approved agent for the treatment of patients with radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC) in November 2013. In this phase III, double-blinded study, 417 patients with locally recurrent or metastatic progressive RAI-refractory DTC were randomized in a 1:1 ratio to receive either sorafenib or placebo. The primary endpoint was progression-free survival (PFS), with a secondary endpoint of overall survival (OS). 

Trial results demonstrated significant improvement (P < .0001) in PFS in patients receiving sorafenib compared with placebo (10.8 months versus 5.8 months). Additionally, 42% of patients in the sorafenib arm had stable disease for >6 months versus 33% with placebo. However, Robert I. Haddad, MD, notes that given the design of the study, which allowed the majority of patients to crossover to receive sorafenib when their cancer got worse, a difference in OS was undetectable. 

Consistent with other TKIs, side effects do exist with sorafenib, but they are manageable, according to Haddad. Two-thirds of patients in the sorafenib group discontinued use or had a dose reduction, and 1 in 5 stopped altogether due to side effects, which included hand-foot skin reactions, diarrhea, hypertension, and alopecia.
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For High-Definition, Click
Based on results from the DECISION trial, the oral TKI sorafenib became the first FDA-approved agent for the treatment of patients with radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC) in November 2013. In this phase III, double-blinded study, 417 patients with locally recurrent or metastatic progressive RAI-refractory DTC were randomized in a 1:1 ratio to receive either sorafenib or placebo. The primary endpoint was progression-free survival (PFS), with a secondary endpoint of overall survival (OS). 

Trial results demonstrated significant improvement (P < .0001) in PFS in patients receiving sorafenib compared with placebo (10.8 months versus 5.8 months). Additionally, 42% of patients in the sorafenib arm had stable disease for >6 months versus 33% with placebo. However, Robert I. Haddad, MD, notes that given the design of the study, which allowed the majority of patients to crossover to receive sorafenib when their cancer got worse, a difference in OS was undetectable. 

Consistent with other TKIs, side effects do exist with sorafenib, but they are manageable, according to Haddad. Two-thirds of patients in the sorafenib group discontinued use or had a dose reduction, and 1 in 5 stopped altogether due to side effects, which included hand-foot skin reactions, diarrhea, hypertension, and alopecia.
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