Sorafenib ( Nexavar ) holds metastatic thyroid cancer at bay for nearly twice as long as a placebo, according to results of a randomized phase III trial, which was presented during the American Society of Clinical Oncology's Annual Meeting.
Sorafenib is a kinase inhibitor that mediates tumor cell division and growth of tumor blood vessels,
Thyroid cancer is highly curable through surgery and radioactive iodine treatment, but about 10% of the 60,000 patients who are diagnosed with the disease each year fail to respond to standard therapies, with tumors eventually appearing in the lymph nodes, bones, lungs, and other sites. The only other drug for advanced thyroid cancer, Doxorubicin, which was approved in 1974, is not used because it is highly toxic and is not effective.
Sorafenib is a breakthrough medication that can stop the progression of the disease for 5 months. The DECISION trial is the first step in a promising series of clinical trials to identify new drugs that are shifting the horizon for patients with advanced thyroid cancer.
Of the 417 metastatic thyroid cancer patients studied in the multicenter, international trial, 207 were randomized to take Sorafenib, an oral drug, and 210 to a placebo arm. Twelve percent of patients experienced tumor shrinkage in the Sorafenib arm, compared to 0.5% of patients taking a placebo. Importantly, the therapy also appeared to thwart disease progression even among many of those whose tumors did not regress: 42 patients who took Sorafenib had stable disease after six months, compared to 33% of those in the placebo group.
Among patients taking Sorafenib, median progression-free survival was 10.8 months, compared to 5.8 months among the placebo group. Patients taking the placebo were allowed to cross over into the Sorafenib arm once their disease progressed; 70% of them did so. Overall survival data is not yet available.
The most common adverse events observed among patients taking Sorafenib included hand-foot skin reaction, diarrhea, alopecia, rash, fatigue, weight loss and hypertension, all of which are consistent with findings from previous trials of the drug for its approved indications. ( Xagena )
Source: University of Pennsylvania School of Medicine, 2013