Frequently Asked Questions

Optune Gio delivers Tumor Treating Fields (TTFields) therapy, a regional, noninvasive antimitotic treatment. TTFields therapy uses 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 Gio delivers TTFields therapy via (transducer) arrays applied to the shaved scalp.^1-4

TTFields therapy doesn't significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells.^5-10

Differences in electrical properties occur at the plasma membrane and within the intracellular and extracellular environments, and become more pronounced at higher stages of malignancy.^9-11

TTFields therapy is able to treat glioblastoma (GBM) tumors within the supratentorial region of the brain. TTFields therapy does 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

Preclinical studies have shown that the optimal tuning frequency for TTFields therapy 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 Gio 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 therapy is targeted to all areas of the suspected tumor. Transducer array layout mapping is performed using the NovoTAL™ software.^14-16

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

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 Gio plus TMZ. Usage (≥75% vs <75%) was an independent predictor of overall survival in the full 5‑year data set.¹⁹

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

The most common (≥10%) AEs involving Optune Gio 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

Optune Gio is not known to be an immunosuppressant.¹

In patients with newly diagnosed GBM, the addition of Optune Gio 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 Gio and 19% in patients treated with best effective standard of care (BSC) chemotherapy.^1,*

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

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 therapy is 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 Gio 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.21 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 Gio. Optune Gio 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

Optune Gio 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 Gio.

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

Optune Gio 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.