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
Alternating electric fields (Optune)
for newly diagnosed GBM
The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers include alternating electric fields (Optune) as a Category 1 Preferred regimen, following maximal safe resection if feasible, or else biopsy and standard radiation therapy with concurrent and adjuvant TMZ, for patients aged ≤70 years with newly diagnosed supratentorial GBM and good performance status§ regardless of MGMT promoter status.
There is uniform NCCN consensus for this recommendation based on high-level evidence (Category 1), and superior efficacy, safety, evidence, and when appropriate, affordability (Preferred).6
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.
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. 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 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers V.1.2023. © National Comprehensive Cancer Network, Inc. All rights reserved. Accessed June 30, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org.
