Sorafenib extended PFS in advanced thyroid cancer
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Sorafenib significantly extended PFS and appeared tolerable in patients with radioactive iodine-refractory locally advanced or metastatic differentiated thyroid cancer, according to phase 3 study results.
The multicenter, double-blind DECISION trial included 417 patients who had progressed within the previous 14 months. Patients had an ECOG performance status of 0 to 2.
Marcia S. Brose
Marcia S. Brose, MD, assistant professor of otolaryngology and head and neck surgery at the Abramson Cancer Center of the University of Pennsylvania, and colleagues randomly assigned 207 patients 400 mg of twice-daily sorafenib (Nexavar, Bayer). The other 210 patients received placebo.
The PFS analysis — initial results of which were presented at the 2013 ASCO Annual Meeting — indicated median PFS was significantly improved with sorafenib (10.8 months vs. 5.8 months; HR=0.59; 95% CI, 0.45-0.76). Researchers noted sorafenib improved PFS regardless of serum thyroglobulin, BRAF or RAS biomarkers.
Safety data were available from 416 patients. The majority of patients assigned sorafenib (98.6%) and placebo (87.6%) experienced adverse effects, but the majority of events were grade 1 or grade 2.
The most common adverse events associated with sorafenib were hand–foot skin reaction (76.3%), diarrhea (68.6%), alopecia (67.1%), and rash or desquamation (50.2%).
“Adverse events were consistent with the known safety profile of sorafenib,” Brose and colleagues concluded. “These results suggest that sorafenib is a new treatment option for patients with progressive radioactive iodine-refractory differentiated thyroid cancer.”
Click here to see Dr. Brose discussing DECISION trial results during the 2013 ASCO Annual Meeting.
Disclosure: The study was funded by Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals.