Recurrent GBM Study Design
In recurrent GBM,
The efficacy and safety of Optune Gio monotherapy were compared with physician’s choice of chemotherapy*
EF-11 phase 3 pivotal trial—Optune Gio vs physician’s choice of chemotherapy, including bevacizumab1
*Therapy options were the physician’s best choice for chemotherapy. The best available therapy was prescribed according to local practice and depending on prior treatment exposure.1
- Approximately 20% of patients in each EF-11 treatment arm had failed a prior bevacizumab-containing regimen1
Key efficacy endpoints
- Primary endpoint
- OS
- Secondary endpoints
- PFS
- 1-year survival
- PFS6
- Median time to progression
- Radiological response rates
- QoL
Some key inclusion criteria1,2
- Not a candidate for further radiotherapy or additional resection of residual tumor
- Subjects with disease progression (by Macdonald criteria, ie, >25% increase in enhancing lesions or new lesion) documented by CT or MRI within 4 weeks prior to enrollment
- KPS ≥70
Some key exclusion criteria1,2
- Significant comorbidities within 4 weeks prior to enrollment
- Surgery for recurrence within 4 weeks
- Infratentorial tumor
- Prior radiation or chemotherapy in the past 4 weeks
- Implanted pacemaker, defibrillator, or deep brain stimulator, or documented clinically significant arrhythmias
EF-11: Key baseline characteristics
Intent to treat (ITT) population1,2
Single agent or combination regimens3†
†Multiple listings possible, some agents given in combination.
BCNU, carmustine; CCNU, lomustine; CT, computed tomography; GBM, glioblastoma; KPS, Karnofsky Performance Score; MRI, magnetic resonance imaging; OS, overall survival; PCV, procarbazine + lomustine + vincristine; PFS, progression-free survival; PFS6, progression-free survival at 6 months; QoL, quality of life.
References: 1. Stupp R, Wong ET, Kanner AA, et al. NovoTTF-100A versus physician’s choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012;48(14):2192-2202. 2. Optune Gio. Instructions For Use. Novocure; 2023. 3. Stupp R, Wong ET, Kanner AA, et al. NovoTTF-100A versus physician’s choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Supplemenary table 1. Accessed October 18, 2023. Eur J Cancer. 2012;48(14):2192-2202. https://www.ejcancer.com/article/S0959-8049(12)00352-8/fulltext#supplementaryMaterial