A randomized trial showed Optune monotherapy demonstrated efficacy comparable to that of chemotherapy*
Median OS was similar at 6.6 months with Optune monotherapy and 6.0 months with physician's choice of chemotherapy1,*
Twice as many patients responded to Optune vs physician’s choice of chemotherapy2
*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
OS correlated with treatment usage in a subgroup analysis of patients treated with Optune3,†
Subgroup analysis of patients receiving Optune
- OS was significantly higher in patients who received Optune for ≥18 hours per day (n=92) vs those who received therapy for <18 hours per day (n=28), 7.7 months vs 4.5 months, respectively3
- Median usage was 86% (range 41%-98%) of the time in each treatment month, translating into a mean use of 20.6 hours per day1
†From a post hoc analysis.
GBM, glioblastoma; OS, overall survival.
- 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.
- Wong ET, Lok E, Swanson KD, et al. Response assessment of NovoTTF-100A versus best physician's choice chemotherapy in recurrent glioblastoma. Cancer Med. 2014;3(3):592-602.
- Kanner AA, Wong ET, Villano JL, Ram Z; EF-11 Investigators. Corrigendum to "Post hoc analyses of intention-to-treat population in phase III comparison of NovoTTF-100ATM system versus best physician's choice of chemotherapy" [Seminars in Oncology, Vol 41, No 5, Suppl 6, October 2014, ppS25-S34]. Semin Oncol. 2015;42(3):e56-e66.
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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.