The Optune Device by Novocure: Understanding the Revolutionary Device for Brain Cancer Treatment

We receive continuous requests for information and so we thought we’d do something useful by submitting an article to clarify things for patients, caregivers, specialists, administrators of local health agencies. The text was prepared in collaboration with Novocure which recently also had an office in Italy.

TTFields (Tumor Treating Fields)

TTFields represent an innovative and non-invasive technique for adults with glioblastoma. They use alternating electric fields that stop tumor cell division or cause cell death, thus preventing the tumor from growing or spreading as rapidly. They are intended for use by adults 18 years of age and older with:

• Newly diagnosed glioblastoma, as an adjunct to temozolomide chemotherapy, after surgery and radiotherapy
• Recurrent glioblastoma.

What is the mechanism of action?

The device, known as Optune, creates alternating electric fields, called Tumor Treating Fields or TTFields. These fields are of low intensity and hinder the cell division process in rapidly dividing cells, such as cancer cells. TTFields are applied at a frequency that specifically affects glioblastoma cells: due to the different characteristics of tumor cells in terms of morphology, electrical properties and rate of division, TTFields specifically target these cells, sparing healthy cells.

How to use the device?

The use of TTFields consists of adhesive plasters that contain isolated ceramic discs, called “arrays”, which are applied to the skin of the head, forming what looks like a “cap”. The arrays are connected via cables to a portable, battery-powered device that can be carried in a shoulder bag or backpack. The portable device is in fact designed to allow patients to maintain their lifestyle, without interrupting their daily habits.

To achieve the best response to treatment, the device should be worn for as long as possible during the day. This is because the effects of TTFields on glioblastoma cells only occur when the treatment is active. The total duration of treatment will be determined by the specialist doctor (oncologist, neuro-oncologist, neurosurgeon, radiotherapist).

Is it available in Italy?

The Optune device has received Food & Drug Administration (FDA) approval in the United States and CE Mark in the European Union for the treatment of adult patients with newly diagnosed and recurrent glioblastoma. This means that in the United States it is considered safe and effective, and the European Union certifies its essential health and safety requirements. It is currently authorized and reimbursed by the National Health Service in Japan, the United States, Germany, Austria, Switzerland, Sweden and France.

Since the device has the CE mark, it can also be prescribed in Italy. It is possible to request authorization from the Local Health Authority (ASL) of the patient’s residence, which decides on a case-by-case basis, but always on the basis of a prescription from a specialist doctor.

The flow required to use the device at the moment is as follows:

• the specialist doctor (oncologist, neuro-oncologist, neurosurgeon or radiotherapist) prescribes, or fills in a clinical report with a request for authorization from the ASL and has the patient sign an indication form, for privacy.
• The Indication Form is sent to Novocure at supportEMEA@novocure.com.
• The clinical report, on the other hand, is delivered to the patient, who must take it to his local ASL according to his residence (depending on the region, the Local Health Authority may be called ASL, ASP, ASST, ULSS, …). In this way the Local Health Authority evaluates and decides whether to approve the treatment and therefore cover the costs.
• supportEMEA@novocure.com is also valid for requesting information from Novocure.

What are the results in clinical trials?

There have been a few clinical trials of TTFields in newly diagnosed and recurrent glioblastoma. Results from a study involving nearly 700 patients showed prolonged survival in newly diagnosed patients with glioblastoma treated together with temozolomide (TMZ). The study showed that patients treated with TTFields had a 5-year survival rate of 13% compared with 5% for patients who did not use TTFields. A sub-analysis of the study also showed that patients who used TTFields more than 90% of the time achieved a 5-year survival rate of 29.3% (compared to 5% in the control arm).

What are the side effects?

TTFields is a local therapy that selectively targets cancer cells and does not determine significant side effects. The most common side effect is mild to moderate scalp irritation, which in most cases can be managed with moisturizers or local treatments without interrupting therapy. It is also important to remember that the scalp must be shaved and this condition is not always viewed favorably by patients.
It is important to remember that the information contained in this article is offered for general guidance and can in no case replace specialist medical advice.