Quality of Life

Health-related quality of life (HR-QoL) in patients treated with Optune Gio

Consistent with EF-14, the first large-scale, real-world study showed that patients on Optune Gio can maintain HR-QoL1

To assess QoL in patients actively using Optune Gio for treatment of GBM, EQ-5D-5L and EQ-VAS questionnaires were sent to 2182 patients in the US and 633 patients in the EU, 1106 of whom were included in the final analysis.1

  • Mean time on Optune Gio in the real-world study was 13.5 months and in EF-14 was 12.5 months1,2
  • The current Optune Gio model is half the size and weight of the model used in this study

Limitations1

  • While the study was designed for ease of completion, patient privacy, and compliance with approved labeling, that meant some details remain unknown about each patient’s disease, treatment, or supportive care that could impact HR-QoL
  • Because all information was self-reported it was not possible to verify responses with medical records
  • There may be a response bias as patients who decided to respond to the survey may not be representative of all patients receiving Optune Gio in the US and the EU

HR-QOL was positively associated with longer time on Optune Gio1

Positive associations*,‡ were found between longer time on Optune Gio and:

Overall health score‡

2.63 (higher values indicate improved self-rated health)

Usual Activities

-0.17 (lower value indicates less impairment)

Mobility

-0.12 (lower scores indicate less impairment)

Self-care

-0.17 (lower scores indicate less impairment)

The possibility of delaying progression with Optune Gio may help maintain patient HR-QoL1

  • Mean EQ-VAS scores were higher for patients with nonprogressed vs progressed disease (73.77 vs 56.80)
Real-world setting results were shown to be consistent with that of the pivotal EF-14 trial

*In the univariate analysis based on log (time on Optune Gio).1
†As measured by EuroQol’s EQ-5D-5L questionnaire and EuroQol’s visual analogue scale (EQ-VAS), a standard questionnaire in which patients can rate their overall health score.1
‡As measured by EQ-VAS.1 
 

EQ-5D-5L, EuroQol 5-dimensional, 5-level survey; EU, European Union; GBM, glioblastoma; HCP, healthcare professional; US, United States.

References: 1. Palmer JD, Chavez G, Furnback W, et al. Health-related quality of life for patients receiving tumor treating fields for glioblastoma. Front Oncol. 2021;11:772261. doi:10.3389/fonc.2021.772261 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. doi:10.1001/jamaoncol.2017.5082 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(3):545-552. doi:10.1007/s11060-017-2601-y

Indications For Use

Optune Gio® 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 Gio® 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

Optunegio.com
Optunelua.com
Novocuretrials.com

Quick links

What Is Optune Gio?
Mechanism of Action
International
Frequently Asked Questions
Contact Us

Legal links

Terms of Use
Privacy Notice

©2025 Novocure GmbH. All Rights Reserved.  

MyLink, MyNovocure, Novocure, and Optune Gio are registered trademarks of Novocure GmbH. 

All other trademarks, registered or unregistered, are the property of their respective owners.

US-OPG-00197v1.0 February 2025 

 

US-OPG-00197 v1.0 February 2025