These results—from a Phase III clinical trial—were presented at the 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO).
Differentiated thyroid cancer is the most common type of thyroid cancer and can often be cured with surgery and radioactive iodine (RAI) treatment. In some cases, however, the cancer is resistant to RAI. RAI-resistant thyroid cancers have had few effective treatment options.
Nexavar is taken orally and targets certain proteins that contribute to cancer growth. It is used to treat advanced kidney cancer and inoperable liver cancer.
To evaluate Nexavar in the treatment of thyroid cancer, researchers conducted a Phase III trial (the DECISION trial). The study enrolled 417 patients with metastatic, RAI-resistant, differentiated thyroid cancer. Patients were treated with either Nexavar or a placebo.
- Progression-free survival (survival without a worsening of the cancer) was 10.8 months in the Nexavar group and 5.8 months in the placebo group.
- Tumor shrinkage of at least 30% occurred in 12% of patients in the Nexavar group and less than 1% of patients in the placebo group.
- The disease control rate (tumor shrinkage or stable disease for at least six months) was 54% in the Nexavar group and 34% in the placebo group.
These results suggest that Nexavar almost doubles progression-free survival among patients with treatment-resistant, metastatic, differentiated thyroid cancer. If Nexavar is approved for this type of cancer, it would be the first new drug in decades to demonstrate effectiveness for this group of patients.
Reference: Brose MS, Nutting C, Jarzab B et al. Sorafenib in locally advanced or metastatic patients with radioactive iodine-refractory differentiated thyroid cancer: The phase III DECISION trial. Presented at the 49th Annual Meeting of the American Society of Clinical Oncology. May 31-June 4, 2013; Chicago, IL. Abstract 4.