Intended for US healthcare professionals only.

Frequently Asked Questions (FAQs)

1

How does Optune work?

Optune delivers Tumor Treating Fields (TTFields) therapy, a regional, noninvasive antimitotic treatment. TTFields are electric fields tuned to specific frequencies (200 kHz) that interfere with mitosis to continuously disrupt cancer cell division, inhibiting tumor growth and potentially causing cancer cells to die. Optune delivers TTFields therapy via (transducer) arrays applied to the shaved scalp.1-4

2

Do TTFields affect normal cells?

TTFields don't significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells5-10

Differences in electrical properties occur at the plasma membrane and within the intracellular and extracellular environments, and become more pronounced at higher stages of malignancy9-11

3

Does tumor size or depth impact the efficacy of TTFields?

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.1,12

4

How was the frequency of Optune determined for GBM?

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.1,3,13

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

5

Can the transducer array layout map be readjusted based on tumor progression?

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.14-16

6

Is there evidence to suggest that TTFields are additive or synergistic with temozolomide (TMZ)?

Preclinical studies in glioblastoma cell lines suggest additive cytotoxic effects when cancer cell lines are exposed to a combination of TTFields and TMZ.17,18

7

How has daily usage of 18 hours been established as optimal?

The results of an EF-14 sub-group 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.19

8

Does Optune make TMZ-induced adverse events (AEs) worse?

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

9

What are the most common AEs with Optune in combination with TMZ?

The most common (≥10%) AEs involving Optune together 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.20,21

10

Is Optune known to suppress the immune system?

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).

11

How frequently should patients on Optune have an MRI scan?

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

12

How soon after surgery, radiation, or prior therapy can a patient start on Optune in the newly diagnosed and in the recurrent setting?

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

13

How long has it taken to see a radiographic response with Optune?

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

14

What should I do when a patient complains about a heat sensation?

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.21 Complaints should be reported to the Novocure Customer Care Team at 1-855-281-9301.

15

Are caregivers or family members at risk of exposure when they are around a patient using Optune?

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.22

16

Are there any limitations with the use of cell phones or microwaves while patients are being treated with Optune?

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.

17

Is Optune covered by insurance companies for the treatment of GBM?

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. Karanam NK, Story MD. An overview of potential novel mechanisms of action underlying tumor treating fields-induced cancer cell death and their clinical implications. Int J Radiat Biol. 2021;97(8):1044-1054.
  6. Cooper GM. The development and causes of cancer. In: The Cell: A Molecular Approach. 2nd ed. Sinauer Associates; 2000: chap 15. Accessed June 21, 2022. https://www.ncbi.nlm.nih.gov/books/NBK9963/
  7. Baba AI, Câtoi C. Tumor cell morphology. In: Comparative Oncology. The Publishing House of the Romanian Academy; 2007: chap 3. Accessed June 21, 2022. https://www.ncbi.nlm.nih.gov/books/NBK9553/
  8. Mulpuru SK, Madhavan M, McLeod CJ, Cha Y-M, Friedman PA. Cardiac pacemakers: function, troubleshooting, and management. Am Coll Cardiol. 2017;69(2):189-210.
  9. Trainito CI, Sweeney DC, Čemažar J, et al. Characterization of sequentially-staged cancer cells using electrorotation. PLoS One. 2019;14(9):1-18.
  10. Haemmerich D, Schutt DJ, Wright AW, Webster JG, Mahvi DM. Electrical conductivity measurement of excised human metastatic liver tumours before and after thermal ablation. Physiol Meas. 2009;30(5):459-466.
  11. Ahmad MA, Al Natour Z, Mustafa F, Rizvi TA. Electrical characterization of normal and cancer cells. IEEE Access. 2018;6:25979-25986.
  12. 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.
  13. Kirson ED, Gurvich Z, Schneiderman R, et al. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004;64(9):3288-3295.
  14. 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. doi:10.1186/1477-7819-12-162
  15. NovoTTF™-100L System. Instructions For Use for Unresectable Malignant Pleural Mesothelioma. 2019.
  16. 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. doi:10.1186/s12957-015-0722-3
  17. 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
  18. 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
  19. 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.
  20. Novocure Data on File OPT-103.
  21. 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
  22. 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).

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

Contraindications

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.

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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

Contraindications

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.