Optune + TMZ efficacy was proven in a phase 3 randomized trial of 695 patients1
EF-14 phase 3 pivotal trial—Optune + TMZ vs TMZ alone in newly diagnosed GBM1-3
Stratification and survival analyses
- Patients were stratified based on extent of resection and MGMT status2
- A prespecified interim analysis occurred when the first 315 patients completed 18 months of follow-up1,2
- The final analysis involved all 695 randomized patients, with a median follow-up of 40 months and a minimum follow-up of 24 months2
Treatments with Optune
- Patients were able to stay on Optune through first progression but could switch additional treatment1,2
- Patients were able to stay on Optune after completing TMZ treatment (6-12 cycles), for up to 24 months or until second progression, whichever came first1,2
- NovoTAL™ System was utilized to create individualized treatment maps for all patients receiving Optune2
- Primary endpoint: PFS, assessed centrally
- Powered secondary endpoint: OS
- Additional secondary endpoints: PFS6, 1- and 2-year survival, QoL, radiological response rates
Key inclusion criteria1,2
- Underwent maximal debulking surgery and radiotherapy concomitant with TMZ
- KPS ≥70
Key exclusion criteria1
- Progressive disease per Macdonald criteria, following concomitant chemoradiation
- Implanted electronic medical devices
- Significant comorbidities at baseline that would prevent maintenance TMZ treatment
- Infratentorial tumor(s)
2L, second line; GBM, glioblastoma; KPS, Karnofsky Performance Score; MGMT, 0-6-methylguanine—DNA methyltransferase; OS, overall survival; PFS, progression-free survival; PFS6, progression-free survival at 6 months; QoL, quality of life; RT, radiation therapy; SRS, stereotactic radiosurgery; TMZ, temozolomide.
- 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, 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. Supplement 1. Trial protocol and statistical analysis plan. JAMA. 2017;318(23):2306-2316. Accessed November 14, 2022. https://jamanetwork.com/journals/jama/fullarticle/2666504
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.