Portable Treatment for Glioblastoma

Optune®, an FDA-approved therapy for the treatment of newly diagnosed and recurrent glioblastoma  (GBM), is now available at Flushing Radiation Oncology Services. This portable and wearable device is the first FDA-approved therapy in more than a decade for newly diagnosed GBM. Optune is approved for the treatment of adult patients (22 years of age or older) with GBM. For newly diagnosed patients, Optune is used with the chemotherapy temozolomide (TMZ) after surgery and radiation with TMZ. For recurrent patients, it can be used alone when surgery and radiation treatment options have been exhausted. In a clinical trial, adding Optune to TMZ was proven to delay GBM tumor growth and extend survival in newly diagnosed patients compared with TMZ alone.

Warnings and Precautions

Do not use Optune if you are pregnant, you think you might be pregnant or are trying to get pregnant. It is not known if Optune is safe or effective in these populations.

The most common (≥10%) adverse events involving Optune in combination with temozolomide were low blood platelet count, nausea, constipation, vomiting, fatigue, scalp irritation from device use, headache, convulsions, and depression.

The most common (≥10%) adverse events seen when using Optune alone were scalp irritation from device use and headache.

The following adverse reactions were considered related to Optune when using the device alone: scalp irritation from device use, headache, malaise, muscle twitching, fall and skin ulcer.

All servicing procedures must be performed by qualified and trained personnel.

Do not use any parts that do not come with the Optune Treatment Kit, or that were not sent to you by the device manufacturer or given to you by your doctor.

Do not wet the device or transducer arrays.

If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune treatment.

Indications for Use

Optune® is intended as a treatment for adult patients (22 years of age or older) with histologicallyconfirmed 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. For the treatment of recurrent GBM, Optune is indicated following histologically–or radiologically–confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.

Do not use Optune if you have 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 if you 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.

Use Optune only after receiving training from qualified personnel, such as your doctor, a nurse, or other medical personnel who have completed a training course given by Novocure™ (the device manufacturer).