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Treatment With Sorafenib Significantly Improves Outcomes for DifferentiatedThyroid Cancer

June 5, 2013 Thyroid cancer comprises approximately 95% of primary cancersinvolving the endocrine system; although rare compared with other cancers, the

incidence of and mortality due to this disease continue to rise globally. Papillary andfollicular carcinomas, including Hrthle cell carcinoma, originate in thyroid epithelialcells and comprise differentiated thyroid cancer (DTC), which accounts forapproximately 94% of thyroid cancers. Although DTC is highly curable with surgeryand radioactive iodine (RAI) therapy, therapeutic options are limited for those withRAI-refractory disease, which is associated with poor survival (median overall survival[OS]: 3 years; 10-year survival: 10%). Responses to traditional therapies in this settingare limited, and toxicities are considerable.

At the 2013 American Society of Clinical Oncology Annual Meeting, Marcia S. Brose,MD (Abramson Cancer Center of the University of Pennsylvania, Philadelphia, UnitedStates), presented findings from the pivotal phase III DECISION trial. Thisrandomized, double-blind, multicenter study was designed to evaluate the safety andefficacy of sorafenib 400 mg twice a day (800 mg/day; n = 207) vs placebo (n = 210) in

patients with locally advanced/metastatic RAI-refractory DTC. Treatment wascontinued until development of radiographically confirmed disease progression orunacceptable toxicity. At progression, patients on placebo were allowed to cross over tosorafenib at the investigators discretion, while patients on the sorafenib arm wereallowed to continue on open-label sorafenib. The primary endpoint of this trial was

progression-free survival (PFS) as defined by RECIST, and key secondary endpointsincluded OS, response rate, and safety.

Important findings from this trial include:

Treatment with sorafenib resulted in a significant improvement in medianPFS (10.8 months vs 5.8 months; hazard ratio [HR] = 0.587; P

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