Optune + TMZ provided an unprecedented long-term survival benefit
Survival with Optune + TMZ vs TMZ alone was significantly higher at the 2-year landmark analysis and remained higher at 5 years1,2
Overall survival (5-year survival analysis)1-3
Proven to provide the best opportunity for greater OS at 5 years vs TMZ alone (13% vs 5%)1
Median OS was significantly extended with Optune—by nearly 5 months (P<0.001)1,2
Optune + TMZ also significantly improved PFS vs TMZ alone1,2
- Median PFS: 6.7 months vs 4.0 months (P<0.001)
More time on Optune predicted increased significant survival benefit4
Median OS by monthly time (hours/day) on Optune*
*Based on the amount of time Optune was turned on and providing therapy over the course of a month. These data reflect the average patient usage of Optune for the first 6 months of treatment (months 1-6).5
†vs TMZ alone.
‡Approximation, based on percentage of usage.
†Approximation, based on percentage of usage.
‡vs TMZ alone.
- Monthly usage was a predictor of survival benefit, independent of other prognostic factors such as KPS, age, or MGMT methylation status4
86% of patients received a survival benefit from Optune because they used it more than half the time (n=388/450)4
Long-term use is supported by strong evidence
Part of a National Comprehensive Cancer Network® (NCCN®)
Category 1 Recommendation
for newly diagnosed GBM5
The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers include alternating electric field therapy (Optune®) together with temozolomide (TMZ) following maximal safe resection and standard brain radiation therapy with concurrent TMZ as a Category 1 recommended treatment option for patients with newly diagnosed supratentorial GBM and good performance status. The NCCN-preferred adjuvant treatment regimen is radiation therapy with concurrent and adjuvant TMZ +/- Optune. There is uniform NCCN consensus for this recommendation based on high-level evidence (Category 1).§
5-year survival analysis was published in JAMA, December 20172
§The NCCN defines good performance as Karnofsky Performance Score (KPS) ≥60. The trial on which the IFU is based used an eligibility criteria of KPS ≥70.2,6
GBM, glioblastoma; KPS, Karnofsky Performance Score; MGMT, O-6-methylguanine-DNA methyltransferase; OS, overall survival; PFS, progression-free survival; TMZ, temozolomide.
The National Comprehensive Cancer Network 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. Instructions for Use for Glioblastoma Multiforme. Novocure; 2019.
- Stupp R, Taillibert S, Kanner A, et al. Effect of tumor-treating fields plus maintenance temozolomide vs maintenance temozolomide alone on survival in patients with glioblastoma: a randomized clinical trial. JAMA. 2017;318(23):2306-2316.
- Stupp R, Idbaih A, Steinberg DM, et al. Prospective, multi-center phase III trial of tumor treating fields together with temozolomide compared to temozolomide alone in newly diagnosed glioblastoma. Presented at: 2017 Annual Meeting of the American Association for Cancer Research; April 1-5, 2017; Washington, DC. Oral presentation LBA AACR CT007.
- Toms SA, Kim CY, Nicholas G, Ram Z. Increased compliance with tumor treating fields therapy is prognostic for improved survival in the treatment of glioblastoma: a subgroup analysis of the EF-14 phase III trial. J Neurooncol. 2019;141(2):467-473.
- Novocure Data on File OPT-135.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers. V.2.2022. © National Comprehensive Cancer Network, Inc. All rights reserved. Accessed October 6, 2022. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org.
Learn more below
Indications for Use
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.
Important Safety Information
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
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.
If the patient has an underlying serious skin condition on the scalp (e.g. ulcers, open wound, broken skin) evaluate whether this may prevent or temporarily interfere with Optune treatment.
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.
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.
Optune can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure (the device manufacturer).
Please click here to see the Optune Instructions for Use (IFU) for complete information regarding the device’s indications, contraindications, warnings and precautions.