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In newly diagnosed GBM,

Patients treated with Optune + TMZ maintained QoL over time across predefined daily functioning domains

Both HCPs and patients reported stable predefined daily functioning scores up to 1 year of Optune use1-3,*,†

  • HCP-reported KPS and patient-reported Global Health Status were
    • Maintained from baseline through 12 months of follow-up
    • Comparable with the TMZ alone arm

QoL Over 12 Months1,2

*HCP-reported data collected per KPS assessment at baseline and then repeated monthly. Patient functional status via KPS (at multiple time points) measured patient independence in activities of daily living.

†Patient-reported data collected per EORTC QLQ-C30 at baseline and months 3, 6, 9, and 12. This 30-question survey covered 5 daily-functioning domains (Physical, Role, Social, Emotional, and Cognitive).

  • In the pivotal study, patients were treated with the first model of Optune, which was twice as large in size and weight (6 lb) than the currently available device (2.7 lb)

Physical, Role, Social, Emotional, and Cognitive Functioning for patients treated with Optune + TMZ all remained stable and comparable with the TMZ alone arm2

Kim, who uses Optune for glioblastoma fishing Kim, who uses Optune for glioblastoma fishing
“Getting used to Optune took a village—Cecil, Ben, me, and my doctors. But I refuse to sit down and give up when it comes to my care. A positive attitude means so much.”

EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30; GBM, glioblastoma; HCPs, healthcare professionals; HRQoL, health-related quality of life; KPS, Karnofsky Performance Score; QoL, quality of life; TMZ, temozolomide.

References:
  1. Zhu JJ, Demireva P, Kanner AA, et al. Health-related quality of life, cognitive screening, and functional status in a randomized phase III trial (EF-14) of tumor treating fields with temozolomide compared to temozolomide alone in newly diagnosed glioblastoma. J Neurooncol. 2017;135:545-552.
  2. Taphoorn MJB, Dirven L, Kanner AA, et al. Influence of treatment with tumor-treating fields on health-related quality of life of patients with newly diagnosed glioblastoma: a secondary analysis of a randomized clinical trial. JAMA Oncol. 2018;4(4):495-504.
  3. Taphoorn MJB, Dirven L, Kanner AA, et al. Influence of treatment with tumor-treating fields and health-related quality of life of patients with newly diagnosed glioblastoma: a secondary analysis of a randomized clinical trial. Supplementary online content. JAMA. 2018;4(4):495-504. Accessed November 14, 2022. https://jamanetwork.com/journals/jamaoncology/fullarticle/2670704
  4. EORTC Quality of Life Group. EORTC QLQ-C30, Version 3.0. 1995. European Organisation for Research and Treatment of Cancer, Belgium.

Learn more below

Newly diagnosed GBM safety

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.

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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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