Tumor Treating Fields Therapy (Optune) for Recurrent Glioblastoma

This Emerging Technology Evidence Report provides an analysis of full published studies in the clinical literature through October 15, 2015. ECRI Institute is anticipating a publication reporting the findings of the EF-14 (NCT00916409) clinical trial that tested the efficacy and safety of the Optune Treatment Kit as an adjuvant to temozolomide for treating patients with newly diagnosed glioblastoma. The findings of this trial may change the conclusions found in this report. ECRI Institute intends to publish an update to this report in 2016.

Proprietary names: OptuneTM Treatment Kit, InovitroTM Lab Research System, NovoTALTM System, NovoTTF-100ATM System, Tumor Treating Field Generator.

Generic names: TTFields therapy, TTF therapy.

Glioblastomas (GBMs) (also known as glioblastoma multiforme) are central nervous system tumors "composed of a heterogeneous mixture of poorly differentiated neoplastic astrocytes."1 GBM is the most common form of malignant primary brain tumor in adults, accounting for approximately 15% of all brain and central nervous system tumors and about 55% of all gliomas.2 GBM is a grade IV astrocytoma, the most deadly type of glial cell tumor.3 Risk factors include age, exposure to radiation, and a family history of brain tumors.

GBM symptoms depend on the tumor's location and may include weakness, numbness, language deficits, seizures, headaches, nausea, vomiting, and confusion.4

GBM is often resistant to standard chemotherapy. At the time of radiographic diagnosis, patients typically undergo a biopsy or a more extensive debulking surgery to remove as much of the tumor as possible.3 Many factors influence clinician and patient decisions regarding surgical intervention. Depending on the patient's physical condition, adjuvant therapy may include radiation, systemic chemotherapy, or both, possibly followed by maintenance therapy with temozolomide.3

Virtually all GBMs recur after first-line treatment, and second-line options depend on prior treatments, the extent and location of recurrence, and the patient's condition.5 Second-line treatments may include debulking surgery with or without local chemotherapy (i.e., nitrosourea wafers Gliadel®), focal radiation therapy (if a...