Sorafenib in locally advanced or metastatic patients with radioactive iodine-refractory differentiated thyroid cancer: The phase III DECISION trial

Reporter: J Taylor Whaley, MD
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: June 5, 2013

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Presenter: Marcia S. Brose, MD
Presenter's Affiliation: Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA

  • Thyroid cancer is fairly common, and is the 6th most common cancer in women; however, death due to thyroid cancer is uncommon, with fewer than 1500 deaths per year.
  • In recent years, the incidence of thyroid cancer, the most common type of endocrine cancer, has increased in both the United States and globally.
  • There are 3 major categories of thyroid cancer with differentiated being the most common type by far. Papillary, follicular, Hurthle cell, and undifferentiated types are all considered differentiated thyroid cancers.
  • Although the vast majority of thyroid cancers are small and curable by surgery and radioactive iodine, 5-10% of patients develop resistance with 2.5-3.5 year survival. Therefore, patients with locally advanced and metastatic radioactive iodine-refractory (RAI) tumors present a challenge that is associate with poor long-term survival.
  • For the past 40 years, no standard of care has existed. In fact, patients rarely saw medical oncologists because the only drug approved by the FDA for radioactive iodine-refractory disease was doxorubicin, considered too toxic for effective treatment.
    • There is thus a clear a need for novel therapeutics in this subset of patients.
    • Thyroid cancers are known to have a high rate of vascular endothelial growth factor (VEGF) expression and are highly vascular.
    • Sorafenib is an orally active, small molecular multi-kinase inhibitor of several kinases, including VEGFR1-3 and Raf kinases. It has shown promising clinical activity in single-arm phase II studies in radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC). In those trials, 15-23% response rates were seen with median progression free survival of 12 months.
  • In preliminary results from another trial, 27% of patients with papillary and 43% of patients with follicular thyroid cancer had some response. Progression free survival was 84 weeks. Of 32 patients with progressive, radioiodine-negative differentiated thyroid cancer treated with sorafenib for 26 weeks, 25% of patients had a partial response, 34% had stable disease, and 22% had progressive disease. Median progression free survival was 14.5 months.
  • The current Phase III DECISION trial was undertaken to evaluate efficacy and safety of sorafenib as first line therapy for patients with advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer.

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