Sorafenib

A phase III, randomized, double-blind, placebo-controlled study (DECISION [NCT00984282]) evaluated the activity of sorafenib in patients with progressive, iodine-refractory, differentiated thyroid cancer.[21] The trial included 417 patients with locally advanced or metastatic RAI−refractory thyroid cancer (papillary, follicular [including Hürthle cell], and poorly differentiated, not anaplastic tumors, defined as beyond well-differentiated tumors or those well-differentiated tumors that become resistant to radioiodine treatment) whose disease had progressed within the past 14 months. Patients were randomly assigned to receive either sorafenib (400 mg twice a day) or placebo. Patients who received previous chemotherapy, thalidomide, or targeted therapy were excluded.[21][Level of evidence B1]

A phase III, randomized, double-blind, placebo-controlled study (DECISION [NCT00984282]) evaluated the activity of sorafenib in patients with progressive, iodine-refractory, differentiated thyroid cancer.[21] The trial included 417 patients with locally advanced or metastatic RAI−refractory thyroid cancer (papillary, follicular [including Hürthle cell], and poorly differentiated, not anaplastic tumors, defined as beyond well-differentiated tumors or those well-differentiated tumors that become resistant to radioiodine treatment) whose disease had progressed within the past 14 months. Patients were randomly assigned to receive either sorafenib (400 mg twice a day) or placebo. Patients who received previous chemotherapy, thalidomide, or targeted therapy were excluded.[21][Level of evidence B1]

The median PFS was 10.8 months in the sorafenib group and 5.8 months in the placebo group (hazard ratio [HR] 0.59; 95% confidence interval [CI], 0.45–0.76; P < .0001).

A phase III, randomized, double-blind, placebo-controlled study (DECISION [NCT00984282]) evaluated the activity of sorafenib in patients with progressive, iodine-refractory, differentiated thyroid cancer.[21] The trial included 417 patients with locally advanced or metastatic RAI−refractory thyroid cancer (papillary, follicular [including Hürthle cell], and poorly differentiated, not anaplastic tumors, defined as beyond well-differentiated tumors or those well-differentiated tumors that become resistant to radioiodine treatment) whose disease had progressed within the past 14 months. Patients were randomly assigned to receive either sorafenib (400 mg twice a day) or placebo. Patients who received previous chemotherapy, thalidomide, or targeted therapy were excluded.[21][Level of evidence B1]

OS was not significantly improved (HR, 0.80; 95% CI, 0.54–1.19; one-sided P = .14), but the median OS had not been reached at the time of primary analysis data cutoff, and crossover was allowed.

A phase III, randomized, double-blind, placebo-controlled study (DECISION [NCT00984282]) evaluated the activity of sorafenib in patients with progressive, iodine-refractory, differentiated thyroid cancer.[21] The trial included 417 patients with locally advanced or metastatic RAI−refractory thyroid cancer (papillary, follicular [including Hürthle cell], and poorly differentiated, not anaplastic tumors, defined as beyond well-differentiated tumors or those well-differentiated tumors that become resistant to radioiodine treatment) whose disease had progressed within the past 14 months. Patients were randomly assigned to receive either sorafenib (400 mg twice a day) or placebo. Patients who received previous chemotherapy, thalidomide, or targeted therapy were excluded.[21][Level of evidence B1]

The objective response rate (all partial responses) was 12.2% in the sorafenib group and 0.5% in the placebo group.

A phase III, randomized, double-blind, placebo-controlled study (DECISION [NCT00984282]) evaluated the activity of sorafenib in patients with progressive, iodine-refractory, differentiated thyroid cancer.[21] The trial included 417 patients with locally advanced or metastatic RAI−refractory thyroid cancer (papillary, follicular [including Hürthle cell], and poorly differentiated, not anaplastic tumors, defined as beyond well-differentiated tumors or those well-differentiated tumors that become resistant to radioiodine treatment) whose disease had progressed within the past 14 months. Patients were randomly assigned to receive either sorafenib (400 mg twice a day) or placebo. Patients who received previous chemotherapy, thalidomide, or targeted therapy were excluded.[21][Level of evidence B1]

Median time-to-progression was 11.1 months in the sorafenib group and 5.7 months in the placebo group (HR, 0.56; 95% CI, 0.43–0.72; P < .001).

A phase III, randomized, double-blind, placebo-controlled study (DECISION [NCT00984282]) evaluated the activity of sorafenib in patients with progressive, iodine-refractory, differentiated thyroid cancer.[21] The trial included 417 patients with locally advanced or metastatic RAI−refractory thyroid cancer (papillary, follicular [including Hürthle cell], and poorly differentiated, not anaplastic tumors, defined as beyond well-differentiated tumors or those well-differentiated tumors that become resistant to radioiodine treatment) whose disease had progressed within the past 14 months. Patients were randomly assigned to receive either sorafenib (400 mg twice a day) or placebo. Patients who received previous chemotherapy, thalidomide, or targeted therapy were excluded.[21][Level of evidence B1]

Adverse events occurred in 98.6% of patients treated with sorafenib and 87.6% of patients treated with placebo. The most common adverse events in the sorafenib group were hand-foot skin reactions (76.3%), diarrhea (68.6%), alopecia (67.1%), and rash or desquamation (50.2%). Most events were grade 1 or 2. Seven squamous cell carcinomas of the skin occurred in the sorafenib group.