According to The Central Brain Tumor Registry of the United States (www.CBTRUS.org), more than 124,000 persons in the United States were living with a diagnosis of primary brain and central nervous system (CNS) cancer in 2004. In 2012, there will be an estimated 22,910 new cases and 13,700 deaths indicating that brain and CNS cancer is one of the most deadly forms of cancer (American Cancer Society: www.cancer.org). The incidence of primary malignant brain cancer has been increasing by about 1.2% each year over the last 30 years (National Comprehensive Cancer Network, NCCN: www.nccn.org). In addition to primary brain and CNS cancer, the NIH estimates that 10-30% of adults with cancer will develop brain metastases (www.nlm.nih.gov). Taking the midpoint of this range and based on an annual incidence of cancer (excluding skin cancers) of 1,596,670 (www.seer.cancer.gov), the annual US incidence of brain metastases is approximately 319,334. Brain metastases are commonly diagnosed in patients with melanoma, breast, and lung cancer.
In the US, each year there are approximately 11,000 new cases of High Grade Glioma (HGG). HGG refers to Grade III and Grade IV gliomas which include anaplastic astrocytoma, anaplastic oligodendroglioma, and Glioblastoma Multiforme (GBM). GBM is the most common form of HGG, accounting for about 50% of all primary brain cancers. Approximately 9,000 new cases are diagnosed each year in the United States (www.CBTRUS.org). Overall, the 1, 5, and 10-year survival rates for patients with GBM are 33.67%, 4.46%, and 2.7% respectively, making it the most fatal form of all primary brain and CNS cancers. Standard of care for the treatment of GBM has essentially remained unchanged for several decades (surgery, radiation, and chemotherapy with an alkylating agent such as temozolamide). In a landmark study led by Roger Stupp, MD, the median survival of subjects was 14.6 months with surgery, radiotherapy and temozolomide and 12.1 months with only surgery and radiotherapy (Stupp, R., NEJM, 2005). Therefore, the need for a breakthrough treatment in this devastating disease is a priority for modern medicine.
Unlike some cancers, GBM does not spread to other organs and it causes adverse symptoms and death by creating pressure on vital brain structures. Thus, control of the brain cancer itself should result in significant improvement in quality of life and outcomes.