Recurrent Efficacy

In recurrent GBM,

A randomized trial showed Optune Gio™ monotherapy demonstrated efficacy comparable to that of chemotherapy*

Median OS was similar at 6.6 months with Optune Gio monotherapy and 6.0 months with physician's choice of chemotherapy1,*

 

Overall Survival1

Twice as many patients responded to Optune Gio vs physician’s choice of chemotherapy2

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.1

OS correlated with treatment usage in a subgroup analysis of patients treated with Optune Gio3,†

Subgroup analysis of patients receiving Optune Gio

  • OS was significantly higher in patients who received Optune Gio for ≥18 hours per day (n=92) vs those who received therapy for <18 hours per day (n=28), 7.7 months vs 4.5 months, respectively3
  • Median usage was 86% (range 41%-98%) of the time in each treatment month, translating into a mean use of 20.6 hours per day1

Learn how Optune Gio impacted quality of life for patients with recurrent GBM

Recurrent GBM quality of life

†From a post hoc analysis.
GBM, glioblastoma; OS, overall survival.

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. Wong ET, Lok E, Swanson KD, et al. Response assessment of NovoTTF-100A versus best physician's choice chemotherapy in recurrent glioblastoma. Cancer Med. 2014;3(3):592-602. 3. Kanner AA, Wong ET, Villano JL, Ram Z; EF-11 Investigators. Corrigendum to "Post hoc analyses of intention-to-treat population in phase III comparison of NovoTTF-100A™ system versus best physician's choice of chemotherapy" [Seminars in Oncology, Vol 41, No 5, Suppl 6, October 2014, ppS25-S34]. Semin Oncol. 2015;42(3):e56-e66.

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-00197 v1.0 November 2023