Biopsy Only Patients

In newly diagnosed GBM,

A post hoc analysis of the EF-14* study showed 
Optune Gio + TMZ was associated with increased median overall survival (OS) vs TMZ alone in patients ineligible for surgical resection1

The EF-14 pivotal phase 3 trial included patients with newly diagnosed GBM who only had a biopsy1

Extent of resection was consistent across both study arms1

The study protocol defined surgery as surgical resection to the extent safely feasible or biopsy.1

OS in biopsy-only patients2

Biopsy-only patients using Optune Gio + TMZ had longer median OS (16.5 months) vs those using TMZ alone (11.6 months)1

  • In the EF-14 trial
    • 13% of patients in each study arm only had a biopsy1
    • 3 patients treated with Optune Gio + TMZ and 1 patient in the TMZ alone group were included in the analysis at 48 months2

In a post hoc analysis of the EF-14* study,

Optune Gio + TMZ improved median survival vs TMZ alone regardless of extent of resection

  • In patients who had a partial resection, median OS was 21.4 months with Optune Gio + TMZ (n=157) compared with 15.1 months with TMZ alone (n=77) (HR: 0.56 [95% CI, 0.41-0.77])1,2
  • In patients who had a gross total resection, median OS was 22.6 months with Optune Gio + TMZ (n=249) compared with 18.5 months with TMZ alone (n=123) (HR: 0.70 [95% CI, 0.54-0.91])1,2

*A randomized, open-label trial in 695 patients with newly diagnosed GBM whose tumor was resected or biopsied and had completed concomitant
 radiochemotherapy were randomized 2:1 to Optune Gio plus maintenance TMZ or TMZ alone.1

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

Newly diagnosed GBM quality of life

GBM, glioblastoma; ITT, intent to treat; TMZ, temozolomide.

References: 1. Stupp R, Taillibert S, Kanner A, et al. Effect of tumor-treating fields plus maintenance temozolomide vs maintenance temozolomide alone on survival in patients with glioblastoma: a randomized clinical trial. JAMA. 2017;318(23):2306-2316. 2. Stupp R, Idbaih A, Steinberg DM, et al. Prospective, multi-center phase III trial of tumor treating fields together with temozolomide compared to temozolomide alone in newly diagnosed glioblastoma. Presented at: 2017 Annual Meeting of the American Association for Cancer Research; April 1-5, 2017; Washington, DC. Oral presentation LBA AACR CT007. 

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