The safety and effectiveness of sorafenib was established in a multicenter, randomized, double-blind, placebo-controlled clinical study involving 417 patients with locally recurrent or metastatic, progressive DTC refractory to RAI treatment. Progression-free survival was the primary efficacy outcome measure determined by a blinded independent radiological review. Other efficacy outcome measures included overall survival, tumor response rate, and duration of response.
Patients were randomized to receive sorafenib 400 mg twice daily (n=207) or placebo (n=210). Forty-eight percent of the patients were male, median age was 63 years, 62% had an Eastern Cooperative Oncology Group performance status of 0, and 99% had undergone thyroidectomy.
The most common side effects in patients treated with sorafenib were alopecia, decreased appetite, diarrhea, fatigue, gastrointestinal and abdominal pain, hand-foot skin reaction, hypertension, infection, nausea, rash, and weight loss.
November 25, 2013
FDA approves Nexavar to treat type of thyroid cancer. FDA News Release. November 22, 2013.
Nexavar® (sorafenib) Full Prescribing Information. http://labeling.bayerhealthcare.com/html/products/pi/Nexavar_PI.pdf. Accessed November 25, 2013.