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In newly diagnosed GBM,

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

  • 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 + TMZ (n=89) vs TMZ alone (n=45)1
  • Patient baseline characteristics and known prognostic factors were balanced between the 2 treatment groups1
  • Median patient age and KPS were 69 years and 90, respectively1
  • Survival rates for patients 65 years of age and older were consistent with the overall trial population1

OS in patients 65 years of age and older1

Survival with Optune + TMZ vs TMZ alone was higher at the 2-year landmark analysis1
In a post hoc analysis,

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

  • No significant increase in systemic AEs in patients treated with Optune + TMZ (46%) vs TMZ alone (40%)1
  • SAEs were reported in 39% of patients treated with Optune + TMZ and in 33% of patients treated with TMZ alone. None were considered related to treatment with Optune1
  • The rate of grade 1 or 2 medical device site reaction was 51% for Optune + TMZ compared with 0% for TMZ alone, and severe (grade 3) skin involvement occurred in 2% of patients treated with Optune + TMZ1
Many elderly patients were able to use Optune effectively, with more than half (57%) achieving average time on treatment of ≥75% (≥18 hours/day)1

*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 TTFields plus maintenance TMZ or TMZ alone.2

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

References:
  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.
  2. 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.

Learn more below

Biopsy-only patients post hoc analysis

Indications for Use

Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).

Optune 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.

Important Safety Information

Contraindications

Do not use Optune in patients with an active implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. Use of Optune together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune ineffective.

Do not use Optune in patients that are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune 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

The most common (≥10%) adverse events involving Optune in combination with temozolomide were thrombocytopenia, nausea, constipation, vomiting, fatigue, medical device site reaction, headache, convulsions, and depression.

If the patient has an underlying serious skin condition on the scalp (e.g. ulcers, open wound, broken skin) evaluate whether this may prevent or temporarily interfere with Optune treatment.

Use of Optune in patients with an inactive implanted medical device in the brain has not been studied for safety and effectiveness, and use of Optune in these patients could lead to tissue damage or lower the chance of Optune being effective.

Do not prescribe Optune for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of Optune in these populations have not been established.

Optune can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure (the device manufacturer).

Please click here to see the Optune Instructions for Use (IFU) for complete information regarding the device’s indications, contraindications, warnings and precautions.

Read more

Indications for Use

Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).

Optune 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.

Important Safety Information

Contraindications

Do not use Optune in patients with an active implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. Use of Optune together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune ineffective.

Do not use Optune in patients that are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune 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

The most common (≥10%) adverse events involving Optune in combination with temozolomide were thrombocytopenia, nausea, constipation, vomiting, fatigue, medical device site reaction, headache, convulsions, and depression.

If the patient has an underlying serious skin condition on the scalp (e.g. ulcers, open wound, broken skin) evaluate whether this may prevent or temporarily interfere with Optune treatment.

Use of Optune in patients with an inactive implanted medical device in the brain has not been studied for safety and effectiveness, and use of Optune in these patients could lead to tissue damage or lower the chance of Optune being effective.

Do not prescribe Optune for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of Optune in these populations have not been established.

Optune can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure (the device manufacturer).

Please click here to see the Optune Instructions for Use (IFU) for complete information regarding the device’s indications, contraindications, warnings and precautions.

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Novocure does not review the information contained on this website and/or database for content, accuracy, or completeness. Use of and access to this information is subject to the terms, limitations, and conditions set by the website and/or database producer.

Novocure makes no representation as to the accuracy or any other aspect of the information contained on such website and/or database, nor does Novocure necessarily endorse such website and/or database.

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