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Combined radiotherapy and chemotherapy with the alkylating agent, temozolomide plus an additional six cycles of temozolomide has been the mainstay of treatment for patients diagnosed with glioblastoma for the past 6 years. Clinically, high variability in the response to this treatment is typically observed, with some patients enjoying progression free survival for longer than others. However, tumour relapse is inevitable in the majority of patients. Local tumour recurrence, occurring within 2-3cm of the original resection cavity (the area exposed to radiation treatment) is most frequently observed. Relapsed glioblastomas are typically unmanageable with median survival after recurrence of only a few months (Brandes et al. 2001). Numerous chemotherapeutic agents have been trialled in patients with recurrent glioblastomas and include enzastaurin (Wick et al. 2010), immunotherapeutic targeting of EGFRvIII (Sampson et al. 2011), cilengitide (trial ongoing) (Reardon et al. 2011), NovoTTF100A (trial ongoing), gefitinib (Uhm et al. 2010), imatinib (Dresemann et al. 2010), bevacizumab plus irinotecan (Vredenburgh et al. 2007). Only bevacizumab has shown promise for the treatment of recurrent glioblastoma, although the benefits of such a drug are still debatable. The Food and Drug Administration (FDA) in the USA approved bevacizumab for GBM under its accelerated approval process. However in Europe, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion. As new therapeutic regimes are developed, it is paramount that we develop a strategy for identifying the patients that will show a positive response to treatment. The recognition and validation of biomarkers of clinical response is important for several reasons: to avoid unnecessary toxicity in patients that fail to respond to the particular treatment; to reduce the colossal cost to healthcare which is typically associated with targeted therapy and most importantly, to better understand drug resistance. This improved knowledge could lead to new strategies to overcome the initial resistance and identify synergistic drug combinations.

Biomarker Discovery, Validation and Clinical Application for Patients Diagnosed with Glioma