Treatment for glioblastoma (GBM)
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Optune® Novocure™

Optune®: Study in newly diagnosed GBM

For people with newly diagnosed GBM, living longer may be possible when Optune is used together with the chemotherapy temozolomide (TMZ). In a clinical trial, using Optune with TMZ was shown to delay GBM tumor growth and extend survival compared with TMZ alone. If you have newly diagnosed GBM and you and your doctor decide to start Optune, it would be used together with the chemotherapy temozolomide (TMZ), after you have already had surgery and radiation with TMZ.


Optune® and TMZ combined is more effective than TMZ alone in a clinical trial


In a clinical study, people with newly diagnosed GBM who used Optune and TMZ had a median* of 7.2 months without their tumor progressing (growing). In comparison, people who used TMZ alone had a median of 4 months without their tumor progressing.


Combining Optune® and TMZ resulted in a median of 3.2 additional months than TMZ alone

* The median was the point where half of the patients in a group had not shown evidence of their tumor progressing.



In the same study, people with newly diagnosed GBM who used Optune and TMZ lived for a median of 20.5 months. In comparison, people who used TMZ alone lived for a median of 15.6 months.


Combining Optune® and TMZ resulted in a median of 4.9 additional months than TMZ alone

The median was the point where half of the patients in a group were still alive.



Approximately half of the people who used Optune with TMZ were alive at 2 years or longer, compared to 32% who were on TMZ alone.


48% of patients lived 2 years or longer when combining Optune® with TMZ


In long-term follow up of 695 people in the same study, the median survival* and median progression-free survival were consistent. Survival at 4 years was 17% for Optune + TMZ vs 10% for TMZ alone.

Optune + TMZ significantly improved median progression-free survival


Before you start therapy, you'll want to learn more about the other benefits and side effects of using Optune.


The benefits of Optune® are it is used with the chemotherapy temozolomide, it treats where the tumor is and thus did not significantly increase TMZ-related side effects, and it is a portable therapy. The most common side effects of Optune® + TMZ that people reported while using Optune with TMZ were low blood platelet count, nausea, constipation, vomiting, fatigue, scalp irritation from device use, headache, convulsions, and depression



Please click here to see the Optune Instructions For Use (IFU) for complete information regarding the device's indications, contraindications, warnings, and precautions.

1. Optune Instructions For Use. Novocure 2016.

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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.

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.

Important Safety Information

Contraindications

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.

Warnings and Precautions

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).

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.


Please click here to see the Optune Instructions For Use (IFU) for complete information regarding the device's indications, contraindications, warnings, and precautions.

Patient Journey videos on this site depict actual patients and caregivers. All other depictions of patients, caregivers, and healthcare professionals are actor portrayals.

Indications For Use

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