OPTUNE® TREATMENT FOR
GLIOBLASTOMA (GBM)
Intended for US healthcare professionals only.

Frequently Asked Questions (FAQs)

  • Optune is a noninvasive, antimitotic cancer treatment for GBM that delivers TTFields. TTFields are electric fields that continuously and selectively disrupt cancer cell division in solid tumors. Optune delivers TTFields therapy via (transducer) arrays applied to the shaved scalp.1-4

  • Because TTFields affect cells undergoing mitosis, most nondividing cells will not be affected. Additionally, cells undergoing mitosis will only be affected if they are in the region treated by the TTFields.3,5

  • TTFields are able to treat glioblastoma (GBM) tumors within the supratentorial region of the brain. TTFields do not attenuate over distance and can reach deep tissues. The transducer array layout is planned to maximize the intensity delivered to the tumor(s) while still covering the entire supratentorial region.1,6

  • Preclinical studies have shown that the optimal tuning frequency for TTFields is inversely related to cell size and that the optimal frequency for GBM cell lines is
    200 kHz.1,3,5

    These treatment parameters are preset by Novocure® into the Optune system, so no electric output adjustments are available.1

  • If a patient’s MRI demonstrates major changes from baseline, the transducer array layout can be remapped to ensure the TTFields are targeted to all areas of the suspected tumor. Transducer array layout mapping is performed using the NovoTAL™ software.7-9

  • Preclinical studies in glioblastoma cell lines suggest additive cytotoxic effects when cancer cell lines are exposed to a combination of TTFields and TMZ.10,11

  • The results of an EF-14 subgroup analysis supported a threshold usage rate of ≥75% for a survival benefit when compared with a usage rate of <75% in patients with newly diagnosed GBM who were treated with Optune plus TMZ. Usage (≥75% vs <75%) was an independent predictor of overall survival in the full 5-year data set.12

  • There were no significant increases in the rate of systemic AEs when Optune was added to TMZ.4

  • The most common (≥10%) AEs involving Optune in combination with TMZ were thrombocytopenia, nausea, constipation, vomiting, fatigue, medical device site reaction, headache, convulsions, and depression. The most common device-related AE, mild to moderate skin irritation, can typically be managed with topical therapies and rarely leads to treatment discontinuation.13,14

  • Optune is not known to be an immunosuppressant.1

    In patients with newly diagnosed GBM, the addition of Optune to TMZ did not increase the incidence of blood and lymphatic system disorders (grades 1-4) compared with TMZ alone (34% for both groups).1

    The most common (≥10%) adverse events (AEs) were thrombocytopenia, nausea, constipation, vomiting, fatigue, medical device site reaction, headache, convulsions, and depression.

    In patients with recurrent GBM, the incidence of blood and lymphatic disorders was 4% in patients treated with Optune and 19% in patients treated with best effective standard of care (BSC) chemotherapy.1,*

    The most common (≥10%) AEs seen with Optune monotherapy were medical device site reaction and headache.

    *BSC chemotherapy included platinum-based chemotherapy (carboplatin), nitrosoureas (BCNU), procarbazine, lomustine, and vincristine (PCV), TMZ, bevacizumab, and imatinib, erlotinib, and irinotecan (mainly in Europe).

  • In the EF-14 phase 3 pivotal trial, patients with newly diagnosed GBM were monitored by MRI every second month from baseline until second progression or 24 months, whichever occurred first. In the case of progression, an unscheduled MRI was obtained within 1 week of the investigator becoming aware. In clinical practice, the frequency should ultimately be determined by the treating physician.1

  • In the EF-14 phase 3 pivotal trial, patients with newly diagnosed GBM needed to have a period of at least 4 weeks from surgery and at least 4 weeks, but not more than
    7 weeks, from the last dose of concomitant TMZ or radiation therapy.1

    In EF-11, patients with recurrent GBM needed to have a period of at least 4 weeks from surgery for recurrence and from any prior chemotherapy or radiation therapy.1

  • As TTFields are a slow antimitotic therapy, we do not expect to see a response quickly with therapy. Using a model developed to simulate the growth kinetics of a malignant tumor, the minimal treatment duration for Optune has been determined to be approximately 4 weeks to reach tumor stabilization. Stopping treatment prior to completion of a 4-week treatment course will most likely lead to continued tumor growth and appearance of symptoms within approximately 1 to 2 weeks.1

  • If a patient complains about a heat or electric sensation, it might be because contact between the transducer arrays and the skin is suboptimal. In such instances, the patient should change the arrays. Patients should also make sure that any wigs, scarves, or hats are loose fitting and well ventilated.14 Complaints should be reported to the Novocure Customer Care Team at 1-855-281-9301.

  • There is no known risk to caregivers exposed to a patient receiving Optune. Optune has been tested for electromagnetic compatibility (active and passive) according to EN ISO 60601-1 standards. This means that no significant electric or magnetic fields are found in the vicinity of the device when it is active.15

  • Optune has been tested for electromagnetic compatibility (active and passive) according to EN ISO 60601-1 standards and Novocure is not aware of any limitations with the use of cell phones or microwaves while patients are being treated with Optune.

  • Novocure assists in all aspects of billing and reimbursement for Optune to help achieve the best possible coverage available from your patients’ insurance.

    Optune is covered by many insurance plans and Novocure ensures that both you and your patient know in advance what, if any, financial obligation your patient has prior to the patient starting therapy.

References: 1. Optune. Instructions for Use for Glioblastoma Multiforme. Novocure; 2019. 2. Gutin PH, Wong ET. Noninvasive application of alternating electric fields in glioblastoma: a fourth cancer treatment modality. Am Soc Clin Oncol Educ Book. 2012:126-131. 3. Kirson ED, Dbalý V, Tovarys F, et al. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci USA. 2007;104(24):10152-10157. 4. 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. 5. Kirson ED, Gurvich Z, Schneiderman R, et al. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004;64(9):3288-3295. 6. Wenger C, Salvador R, Basser PJ, Mirandaet PC. Improving tumor treating fields treatment efficacy in patients with glioblastoma using personalized array layouts. Int J Radiat Oncol Biol Phys. 2016;94(5):1137-1143. 7. Turner SG, Gergel T, Wu H, et al. The effect of field strength on glioblastoma multiforme response in patients treated with the NovoTTF-100L system. World J Surg Oncol. 2014;12:162. 8. NovoTTF-100L System. Instructions for Use for Unresectable Malignant Pleural Mesothelioma. 2019. 9. Chaudhry A, Benson L, Varshaver M, et al. NovoTTF-100A System (Tumor Treating Fields) transducer array layout planning for glioblastoma: a NovoTAL system user study. World J Surg Oncol. 2015;13:316. 10. Kirson ED, Schneiderman RS, Dbalý V, et al. Chemotherapeutic treatment efficacy and sensitivity are increased by adjuvant alternating electric fields (TTFields). BMC Med Phys. 2009;9:1. doi:10.1186/1756-6649-9-1 11. Silginer M, Weller M, Stupp R, Roth P. Biological activity of tumor-treating fields in preclinical glioma models. Cell Death Dis. 2017;8(4):e2753. doi:10.1038/cddis.2017.171 12. 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. 13. Novocure Data on File OPT-103. 14. Lacouture ME, Anadkat MJ, Ballo MT, et al. Prevention and management of dermatologic adverse events associated with tumor treating fields in patients with glioblastoma. Front Oncol. 2020;10:1045. doi:10.3389/fonc.2020.01045 15. Optune Patient Information and Operation Manual. Novocure 2019.

Indications For Use

Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).