Elderly Patients

In newly diagnosed GBM,

A post hoc analysis of the EF-14* study demonstrated that Optune Gio + TMZ was associated with increased overall survival (OS) in elderly patients1

OS patients 65 years and older1

  • This post hoc subgroup analysis included data from all 134 patients 65 years of age and older in the intent-to-treat population, and compared OS, PFS, and safety between the 2 treatment arms:
Optune Gio + TMZ (n=89) vs TMZ alone (n=45)
  • Patient baseline characteristics and known prognostic factors were balanced between the 2 treatment groups1
  • Median patient age and KPS were 69 years and 90 years, respectively1
  • Survival rates for patients 65 years of age and older were consistent with the overall trial population1

*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.2

Survival with Optune Gio + TMZ vs TMZ alone was higher at the 2-year landmark analysis1

In a post hoc analysis,

Optune Gio + TMZ was also associated with improved PFS vs TMZ alone in elderly patients1

  • Median PFS: 6.5 months vs 3.9 months (HR: 0.47 [95% CI, 0.30-0.74])1

Optune Gio + TMZ in elderly patients showed no significant increase in AEs1

  • No significant increase in systemic AEs in patients treated with Optune Gio + TMZ (46%) vs TMZ alone (40%)1
  • SAEs were reported in 39% of patients treated with Optune Gio + TMZ and in 33% of patients treated with TMZ alone. None were considered related to treatment with Optune Gio1
  • The rate of grade 1 or 2 medical device site reaction was 51% for Optune Gio + TMZ compared with 0% for TMZ alone, and severe (grade 3) skin involvement occurred in 2% of patients treated with Optune Gio + TMZ1

Many elderly patients were able to use Optune Gio effectively, with more than half (57%) achieving average time on treatment of ≥75% 
(≥18 hours/day)1

Learn how Optune Gio increased survival for biopsy-only patients

Biopsy-only patients post hoc analysis

AEs, adverse events; GBM, glioblastoma; KPS, Karnofsky Performance Score; PFS, progression-free survival; SAEs, serious adverse events; TMZ, temozolomide.

Reference: 1. Ram Z, Kim CY, Hottinger AF, Idbaih A, Nicholas G, Zhu JJ. Efficacy and safety of Tumor Treating Fields (TTFields) in elderly patients with newly diagnosed glioblastoma: subgroup analysis of the phase 3 EF-14 clinical trial. Front Oncol. 2021;11:671972. doi:10.3389/fonc.2021.671972 

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