Treatment for glioblastoma (GBM)
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Optune® Novocure™

Newly diagnosed GBM safety

Optune was safely combined with TMZ1

No late-emerging serious AEs were seen in the 5-year follow-up

Incidence of grade 3/4 AEs occurring in 5% of
patients during 5 years of follow-up
Optune + TMZ
(n=456)
%
TMZ Alone
(n=216)
%
≥ 1 AE 48 44
Blood and lymphatic system disorders* 13 11
Thrombocytopenia 9 5
Gastrointestinal disorders 5 4
Asthenia, fatigue, and gait disturbance 9 6
Infections 7 5
Injury, poisoning, and procedural complications
(falls and medical device site reaction)
5 3
Metabolism and nutrition disorders
(anorexia, dehydration, and hyperglycemia)
4 5
Musculoskeletal and connective tissue disorders 5 4
Nervous system disorders 24 20
Seizures 6 6
Respiratory, thoracic, and mediastinal disorders
(pulmonary embolism, dyspnea, and aspiration pneumonia)
5 5

*The numerically slightly higher incidence of hematological toxicity, fatigue, and some other AEs are due to the longer duration and observation time in the Optune group. The differences disappear when data are normalized to treatment duration.

No significant increase in serious AEs compared with TMZ alone1

  • The most common (≥10%) AEs involving Optune in combination with temozolomide were thrombocytopenia, nausea, constipation, vomiting, fatigue, medical device site reaction, headache, convulsions, and depression2

  • Grade 3/4 AEs were well balanced between arms. None of the systemic grade 3/4 AEs were considered related to Optune by any of the investigators1

  • The rate of grade 1/2 medical device site reaction was 52% for Optune + TMZ compared with 0% for TMZ alone. Historically, a slightly higher incidence of grade 1/2 AEs was seen in some of the systems in the Optune + TMZ arm of the study. This is most likely a reflection of the longer duration of TMZ treatment in these patients3

  • Mild-to-moderate skin irritation, the most common device-related side
    effect with Optune, was easily manageable, reversible, and did not result in treatment discontinuation1

AEs, adverse events; GBM, glioblastoma; TMZ, temozolomide.

References: 1. 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. 2. Novocure Data on File OPT-103. 3. Optune Instructions For Use. Novocure 2016.

Educational resources

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*The NCCN defines good performance as Karnofsky Performance Score (KPS) ≥60. The trial for which the IFU is based used an eligibility criteria of KPS ≥70.
The NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

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 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

Optune can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure (the device manufacturer).

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.

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.

The most common (10%) adverse events seen with Optune monotherapy were medical device site reaction and headache.

The following adverse reactions were considered related to Optune when used as monotherapy: medical device site reaction, headache, malaise, muscle twitching, fall and skin ulcer.

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.

If the patient has an underlying serious skin condition on the scalp, evaluate 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.

On this site, patient and healthcare professional videos as well as all images labeled as Optune users, caregivers, or healthcare professionals depict actual patients, caregivers, and healthcare professionals. All other depictions of patients and caregivers 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).