Newly Diagnosed Quality of Life

In newly diagnosed GBM,

QoL was maintained over 12 months in patients treated with Optune Gio™ + TMZ

To measure QoL while using Optune Gio, patients were asked a broad range of questions from the EORTC Quality of Life survey across 5 categories related to daily living and physical-cognitive functioning1,2:

Physical

eg, carrying luggage

Role

eg, work/daily job

Social

eg, family life

Emotional

eg, level of tension

Cognitive

eg, remembering things

Optune Gio did not impact patients’ cognitive function or performance of daily physical activities

Both HCPs and patients reported stable predefined daily functioning scores up to 1 year of Optune Gio use3,4,*,†

  • 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

*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).

QoL Over 12 Months3,4

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

''Optune Gio has been an excellent treatment option for me, and I have been using it for more than two years…it does not impede my movement.''

 

– Scott, Optune Gio user and Patient Ambassador​

Patient image reflects the health status of the patient at the time the photo was taken.

Learn about Optune Gio’s safety profile 

Newly diagnosed GBM safety
Watch Dr. Khagi's journey alongside his patients sharing his personal experience prescribing and wearing Optune Gio

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. 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 2. EORTC Quality of Life Group. EORTC QLQ-C30, Version 3.0. 1995. European Organisation for Research and Treatment of Cancer, Belgium. 3. 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. 4. 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.

Indications For Use

 

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

 

Optune Gio 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 Gio 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 Gio in patients with an active implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune Gio together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. Use of Optune Gio together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune Gio ineffective.

 

Do not use Optune Gio in patients that are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune Gio 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 Gio 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 Gio for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of Optune Gio in these populations have not been established.

 

The most common (≥10%) adverse events involving Optune Gio 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 Gio monotherapy were medical device site reaction and headache.
The following adverse reactions were considered related to Optune Gio when used as monotherapy: medical device site reaction, headache, malaise, muscle twitching, fall, and skin ulcer.

 

Use of Optune Gio in patients with an inactive implanted medical device in the brain has not been studied for safety and effectiveness, and use of Optune Gio in these patients could lead to tissue damage or lower the chance of Optune Gio being effective.

 

If the patient has an underlying serious skin condition on the scalp, evaluate whether this may prevent or temporarily interfere with Optune Gio treatment.

 

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

Novocure Websites

This website is intended for people seeking information on Optune Gio.

On this site, videos and images identified as Optune Gio users, caregivers, or healthcare professionals depict actual patients, caregivers, and healthcare professionals.

Patient images reflect the health status of the patients at the time each photo or video was taken.

 

External links

Tumortreatingfieldstherapy.com
Optunegio.com
Optunelua.com
Novocuretrials.com

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US-OPG-00197v1.0 November 2023