Treatment for glioblastoma (GBM)
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Optune® Novocure™

Newly diagnosed GBM safety

Optune was safely combined with TMZ1-7

No significant increase in serious AEs compared with TMZ alone1-7

Incidence of grade 3/4 AEs occurring in ≥2% of patients during long-term follow-up4-7

System Organ Class Adverse Event Optune + TMZ
(n=456)
TMZ alone (n=216)
    Grade 3 Grade 4 Grade 3 Grade 4
Blood and lymphatic system disorders Leukopenia 2% 0% <1% 0%
Lymphopenia 3% 1% 3% 0%
Neutropenia 2% 1% 1% <1%
Thrombocytopenia 6% 3% 4% 1%
Gastrointestinal disorders   5% <1% 3% <1%
General disorders and
administration site conditions
Asthenia 3% 0% 1% 0%
Fatique 4% 0% 3% 0%
Gait disturbance 2% 0% 1% 0%
Infections   7% <1% 4% 1%
Procedural complications Fall 2% 0% 1% 0%
Medical device site reaction 2% 0% 0% 0%
Metabolism and nutrition disorders Hyperglycemia <1% 1% 2% 0%
Musculoskeletal and connective
tissue disorders
  4% <1% 4% 0%
Nervous system disorders Aphasia 2% 0% 1% 0%
Brain edema 2% <1% 2% <1%
Convulsion 5% 1% 6% <1%
Headache 3% 0% 2% 0%
Hemiparesis 4% 0% 2% 0%
Neurological
decompensation
2% 0% 1% 0%
Psychiatric disorders   3% 1% 3% 0%
Renal and urinary disorders   1% 0% 2% 0%
Respiratory, thoracic, and
mediastinal disorders
Pulmonary embolism <1% 3% <1% 2%
Vascular disorders Hypertension 2% 0% <1% 0%
  • 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 depression2

  • A slightly higher incidence of grade 1/2 adverse events 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 patients1

  • Grade 3/4 adverse events were well balanced between arms. None of the systemic grade 3/4 adverse events 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 1% for TMZ alone. The 1% in the TMZ alone arm was due to patients who received Optune off protocol7

  • Mild to moderate skin irritation, the most common device-related side effect with Optune, was easily manageable, reversible, and did not result in treatment discontinuation2

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

References: 1. Optune Instructions For Use. Novocure 2016. 2. Novocure Data on File. OPT-103. 3. Stupp R, Taillibert S, Kanner AA, et al. Maintenance therapy with tumor-treating fields plus temozolomide vs temozolomide alone for glioblastoma: a randomized clinical trial. JAMA. 2015;314(23):2535-2543. 4. Stupp R, Idbaih A, Steinberg DM, et al. Prospective, multi-center phase III trial of tumor treating fields together with temozolomide compared to temozolomide alone in patients with newly diagnosed glioblastoma. In: Program and abstracts of the 2016 Annual Meeting of the Society for Neuro-Oncology; November 17-20, 2016; Scottsdale, AZ. Abstract LTBK-01. 5. Stupp R, Idbaih A, Steinberg DM, et al. Prospective, multi-center phase III trial of tumor treating fields together with temozolomide compared to temozolomide alone in patients with newly diagnosed glioblastoma. Presented at: 2016 Annual Meeting of the Society for Neuro-Oncology; November 17-20, 2016; Scottsdale, AZ. Oral presentation LTBK-01. 6. Stupp R, Hegi ME, Idbaih A, et al. Tumor treating fields added to standard chemotherapy in newly diagnosed glioblastoma (GBM): fInal results of a randomized, multicenter, phase III trial. In: Program and abstracts of the 2017 Annual Meeting of the American Association for Cancer Research; April 1-5, 2017; Washington, DC. Abstract LBA AACR CT007. 7. Stupp R, Hegi ME, Idbaih A, et al. Tumor treating fields added to standard chemotherapy in newly diagnosed glioblastoma (GBM): final results of a randomized, multicenter, phase III trial. Presented at: 2017 Annual Meeting of the American Association for Cancer Research; April 1-5, 2017; Washington, DC. Oral presentation LBA AACR CT007.

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OPT-055.2-08


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.

Patient Journey videos on this site depict actual patients and caregivers. All other depictions of patients, caregivers and health care 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).