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In recurrent GBM,

The efficacy and safety of Optune monotherapy were compared with physician's choice of chemotherapy*

EF-11 phase 3 pivotal trial—Optune vs physician’s choice of chemotherapy, including bevacizumab1

*Therapy options were the physician's best choice for chemotherapy. The best available therapy was prescribed according to local practice and depending on prior treatment exposure.

  • Approximately 20% of patients in each EF-11 treatment arm had failed a prior bevacizumab-containing regimen1

Key efficacy endpoints1,2

  • Primary endpoint
    • OS
  • Secondary endpoints
    • PFS
    • 1-year survival
    • PFS6
    • Median time to progression
    • Radiological response rates
    • QoL

Key inclusion criteria1,2

  • Not a candidate for further radiotherapy or additional resection of residual tumor
  • Subjects with disease progression (by Macdonald criteria, ie, >25% or new lesion) documented by CT or MRI within 4 weeks prior to enrollment
  • KPS ≥70

Key exclusion criteria1,2

  • Significant comorbidities within 4 weeks prior to enrollment
  • Surgery for recurrence within 4 weeks
  • Infratentorial tumor
  • Prior radiation or chemotherapy in the past 4 weeks
  • Implanted pacemaker, defibrillator, or deep brain stimulator, or documented clinically significant arrhythmias

EF-11: Key baseline characteristics

Intent to treat (ITT) population

Single agent or combination regimens

†Multiple listings possible, some agents given in combination.

BCNU, carmustine; CCNU, lomustine; CT, computed tomography; GBM, glioblastoma; KPS, Karnofsky Performance Score; MRI, magnetic resonance imaging; OS, overall survival; PCV, procarbazine + lomustine + vincristine; PFS, progression-free survival; PFS6, progression-free survival at 6 months; QoL, quality of life.

References:
  1. Stupp R, Wong ET, Kanner AA, et al. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012;48(14):2192-2202.
  2. Optune Instructions for Use. Novocure 2019.

Learn more below

Practice support

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.

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

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.

If the patient has an underlying serious skin condition on the scalp (e.g. ulcers, open wound, broken skin) evaluate whether this may prevent or temporarily interfere with Optune treatment.

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.

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.

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

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

Read more

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.

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

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.

If the patient has an underlying serious skin condition on the scalp (e.g. ulcers, open wound, broken skin) evaluate whether this may prevent or temporarily interfere with Optune treatment.

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.

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.

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

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

Leaving Optune.com

Novocure does not review the information contained on this website and/or database for content, accuracy, or completeness. Use of and access to this information is subject to the terms, limitations, and conditions set by the website and/or database producer.

Novocure makes no representation as to the accuracy or any other aspect of the information contained on such website and/or database, nor does Novocure necessarily endorse such website and/or database.

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