2013 - DECISION Trial: Sorafenib improves progression-free survival in patients with radioactive iodine refractory differentiated thyroid cancer
Bayer HealthCare and Onyx Pharmaceuticals have announced that a phase III trial of Nexavar ( Sorafenib ) tablets in patients with locally advanced or metastatic radioactive iodine ( RAI )-refractory differentiated thyroid cancer has met its primary endpoint of a statistically significant improvement in progression-free survival. The study, called DECISION, evaluated the efficacy and safety of Sorafenib compared to placebo. The safety and tolerability were generally consistent with the known profile of Sorafenib.
The DECISION ( stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid cancer ) trial was an international, multicenter, randomized, placebo-controlled study that randomized 417 patients with locally advanced or metastatic, radioactive iodine-refractory, differentiated thyroid cancer ( papillary, follicular, Hürthle cell and poorly differentiated ) who had received no prior chemotherapy, tyrosine kinase inhibitors, monoclonal antibodies that target VEGF or VEGF receptor, or other targeted agents for thyroid cancer.
Patients were randomized to receive 400 mg of oral Sorafenib twice daily or matching placebo. At the time of progression, patients receiving placebo had the option to cross over to Sorafenib at the discretion of the investigator, based on the patients clinical status. The primary endpoint of the study was progression-free survival, as defined by Response Evaluation Criteria in Solid Tumors ( RECIST ). Secondary endpoints included overall survival, time to progression, response rate and duration of response. Safety and tolerability were also evaluated.
Thyroid cancer, one of the few cancers that has increased in incidence over the past several years, is the sixth most common cancer in women, with about three times as many women as men diagnosed. There are more than 160,000 new cases of thyroid cancer and approximately 25,000 people die worldwide each year.
Papillary and follicular types of thyroid cancer are classified as differentiated and account for that vast majority of thyroid cancers. While the majority of differentiated thyroid cancers are treatable, RAI-refractory, locally advanced, or metastatic disease is more difficult to treat and is associated with a lower survival rate.
Nexavar, an oral anti-cancer therapy for liver cancer and for the treatment of patients with advanced kidney cancer, is currently approved in more than 100 countries worldwide. In Europe, Nexavar is approved for the treatment of hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma ( RCC ) who have failed prior Interferon-alpha or Interleukin-2 based therapy or are considered unsuitable for such therapy.
In preclinical studies, Nexavar has been shown to inhibit multiple kinases thought to be involved in both cell proliferation and angiogenesis, two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.
Source: Bayer, 2013