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In newly diagnosed GBM,

A post hoc analysis of the EF-14* study showed Optune + 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 + TMZ had longer median OS (16.5 months) vs those using TMZ alone (11.6 months)1
  • In the EF-14 trial1
    • 13% of patients in each study arm only had a biopsy
    • 3 patients treated with Optune + 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 + 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 + 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 + 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 TTFields plus maintenance TMZ or TMZ alone.1

GBM, glioblastoma; ITT, intent to treat; TMZ, temozolomide; TTFields, Tumor Treating Fields.

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.

Learn more below

Newly diagnosed GBM quality of life

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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