Peer-Reviewed Publications

Peer-reviewed publications

Take a look at the Optune Gio publications

Unprecedented 5-year survival data for newly diagnosed glioblastoma from the EF-14 trial published in JAMA

Effect of Tumor-Treating Fields plus maintenance temozolomide vs maintenance temozolomide alone on survival in patients with glioblastoma: a randomized clinical trial.

 

Journal of the American Medical Association

Stupp R, Taillibert S, Kanner A, et al. 2017;318(23):2306-2316.


Copyright 2017 American Medical Association. All rights reserved.

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The EF-11 trial: Pivotal phase 3 data for recurrent glioblastoma published in the European Journal of Cancer

NovoTTF-100A versus physician’s choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality.

 

European Journal of Cancer


Stupp R, Wong ET, Kanner AA, et al. 2012;48(14):2192-2202.


Copyright 2012 Elsevier. All rights reserved.

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Management of dermatologic adverse events


Prevention and management of dermatologic adverse events associated with Tumor Treating Fields in patients with glioblastoma.

 

Frontiers in Oncology


Lacouture ME, Anadkat MJ, Ballo MT, et al. 2020;10:1045. doi:10.3389/fonc.2020.01045.


Copyright © 2020 Lacouture, Anadkat, Ballo, Iwamoto, Jeyapalan, La Rocca, Schwartz, Serventi and Glas.

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Results from the NovoTALTM System User Study


NovoTTF™-100A System (Tumor Treating Fields) transducer array layout planning for glioblastoma: a NovoTAL™ system user study.

 

World Journal of Surgical Oncology


Chaudhry A, Benson L, Varshaver M, et al. 2015;13:316. doi: 10.1186/s12957-015-0722-3

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A meta-analysis evaluating OS in patients treated with TTFields


Association of Tumor Treating Fields (TTFields) therapy with survival in newly diagnosed glioblastoma: a systematic review and meta‑analysis

 

Journal of Neuro-Oncology


Ballo MT, Conlon P, Lavy-Shahaf G, Kinzel A, Vymazal J, Rulseh AM. 2023;164(1):1-9. doi:10.1007/s11060-023-04348-w

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Subgroup analysis of the EF-14 trial


Increased compliance with tumor treating fields therapy is prognostic for improved survival in the treatment of glioblastoma: a subgroup analysis of the EF-14 phase III trial

 

Journal of Neuro-Oncology


Toms SA, Kim CY, Nicholas G, Ram Z. 2019;141(2):467-473. doi:10.1007/s11060-018-03057-z

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Influence of TTFields on health-related quality of life


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 Oncology


Taphoorn MJB, Dirven L, Kanner AA, et al. 2018;4(4):495-504.
© 2018 American Medical Association. All rights reserved.

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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