Treatment for glioblastoma (GBM)
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NovoTAL™ System utilized to create individualized treatment maps for all patients receiving Optune
Approximately 20% of patients in each EF-11 treatment arm had failed a prior bevacizumab-containing regimen
Primary endpoint
OS
Secondary endpoints
1-year survival
PFS6
Median time to progression
Radiological response rates
QoL
See how Tumor Treating Fields (TTFields) disrupt mitosis and inhibit tumor growth.
Watch videoNot a candidate for further radiotherapy or additional resection of residual tumor
Subjects with disease progression (by Macdonald criteria, ie, >25% or new lesion) documented by CT or MRI within 4 weeks prior to enrollment
KPS ≥70
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 arrythmias
| Characteristics | Optune (n=120) n (%) |
Chemotherapy* (n=117) n (%) |
|
|---|---|---|---|
| Median age (years) | 54 | 54 | |
| Female gender | 28 (23) | 44 (38) | |
| Median KPS (min, max) | 80 (50, 100) | 80 (50, 100) | |
| Frontal tumor position | 38 (32) | 58 (50) | |
| Prior therapy | 1st recurrence | 11 (9) | 17 (15) |
| 2nd recurrence | 58 (48) | 54 (46) | |
| ≥3rd recurrence | 51 (43) | 46 (39) | |
| Re-operation for recurrence | 33 (28) | 29 (25) | |
| Prior bevacizumab use | 23 (19) | 21 (18) | |
| Largest tumor diameter at randomization, median (range), cm |
6.1 (0-15.2) | 5.5 (0-16.2) | |
| Median time from diagnosis to randomization (days) |
335 | 340 |
| Chemotherapy | HR (95% CI) |
|---|---|
| Bevacizumab | 36 (31) |
| Irinotecan | 36 (31) |
| BCNU/CCNU | 29 (25) |
| Carboplatin | 15 (13) |
| Temozolomide | 13 (11) |
| PCV | 10 (9) |
CT, computed tomography; GBM, glioblastoma; KPS, Karnofsky performance status; MRI, magnetic resonance imaging; OS, overall 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. Nabors LB, Ammirati M, Bierman PJ, et al. National Comprehensive Cancer Network. Central nervous system cancers: clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2013; 11(9):1114-1151.
See how Tumor Treating Fields (TTFields) disrupt mitosis and inhibit tumor growth.
Watch videoOPT-055.3-05
*The NCCN defines good performance as Karnofsky Performance Score (KPS) ≥60. The trial for which the IFU is based used an eligibility criteria of KPS ≥70.
The NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery, and completion of radiation therapy together with concomitant standard of care chemotherapy.
For the treatment of recurrent GBM, Optune is indicated following histologically- or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
Contraindications
Do not use Optune in patients with an active implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. Use of Optune together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune ineffective.
Do not use Optune in patients that are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune may commonly cause increased redness and itching, and rarely may even lead to severe allergic reactions such as shock and respiratory failure.
Warnings and Precautions
Optune can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure (the device manufacturer).
Do not prescribe Optune for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of Optune in these populations have not been established.
The most common (≥10%) adverse events involving Optune in combination with temozolomide were thrombocytopenia, nausea, constipation, vomiting, fatigue, medical device site reaction, headache, convulsions, and depression.
The most common (≥10%) adverse events seen with Optune monotherapy were medical device site reaction and headache.
The following adverse reactions were considered related to Optune when used as monotherapy: medical device site reaction, headache, malaise, muscle twitching, fall and skin ulcer.
Use of Optune in patients with an inactive implanted medical device in the brain has not been studied for safety and effectiveness, and use of Optune in these patients could lead to tissue damage or lower the chance of Optune being effective.
If the patient has an underlying serious skin condition on the scalp, evaluate whether this may prevent or temporarily interfere with Optune treatment.
Please click here to see the Optune Instructions For Use (IFU) for complete information regarding the device's indications, contraindications, warnings, and precautions.
On this site, patient and healthcare professional videos as well as all images labeled as Optune users, caregivers, or healthcare professionals depict actual patients, caregivers, and healthcare professionals. All other depictions of patients and caregivers are actor portrayals.
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
* In 2015, SOC was considered surgery, radiation, and TMZ.4
† Median survival is shown as time from randomization. In the EORTC/NCIC study, patients were randomized within 6 weeks of diagnosis.2 In the EF-14 study, patients were randomized 4 to 6 weeks after chemoradiation, which was a median of 3.8 months from diagnosis.1
‡ In 2005, SOC was considered surgery and radiation.5
EORTC/NCIC, European Organisation for Research and Treatment of Cancer/National Cancer Institute of Canada; OS, overall survival; SOC, standard of care; TMZ, temozolomide.
