JAMA Oncology Publishes EF-14 Pivotal Trial Analysis Showing Optune Plus Temozolomide Improved Survival without Negatively Influencing Health-Related Quality of Life Compared to Temozolomide Alone in Newly Diagnosed GBM Patients
Health-related quality of life was maintained for a longer period of time in several predefined health scales in EF-14 trial patients treated with a combination of Optune and temozolomide compared to patients treated with temozolomide alone
The use of Optune together with temozolomide extended progression free and overall survival in newly diagnosed glioblastoma patients
The prespecified analysis concludes that improved progression free and overall survival without a negative influence on health-related quality of life supports the addition of Optune to standard treatment in patients with glioblastoma
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“When treating cancer patients, we must determine the net clinical benefit before introducing new or additional treatments that improve survival compared to standard of care,” said Martin J.B. Taphoorn, MD,
Health-related quality of life was a predefined secondary endpoint of the study, which was measured with validated health-related quality of life questionnaires (EORTC QLQ-C30 and QLQ-BN20) at the beginning of the trial and every three months after. Of the 695 patients in the study, 639 patients completed the baseline questionnaire. Health-related quality of life over time was assessed for nine preselected scales: global health status, physical, cognitive, role, social and emotional functioning, itchy skin, pain and weakness of legs. The results were as follows:
- More patients treated with the combination of Optune and temozolomide reported stable or improved scores on: global health status (53 percent versus 38 percent, p=.001), pain (57 percent versus 36 percent, p<.0001), physical functioning (54 percent versus 38 percent, p=.001) and leg weakness (59 percent versus 42 percent, p=.001) when compared to patients treated with temozolomide alone.
- Deterioration-free survival (the time until quality of life declined by more than 10 points or disease progression) was longer (p<.01) for patients treated with the combination of Optune and temozolomide versus patients treated with temozolomide alone for: global health (4.8 versus 3.3 months), physical (5.1 versus 3.7 months) and emotional functioning (5.3 versus 3.9 months), pain (5.6 versus 3.6 months) and leg weakness (5.6 versus 3.9 months).
- Time to deterioration (the time until quality of life declined by more than 10 points, excluding disease progression) did not significantly differ between treatment arms, except for itchy skin (8.2 months for patients treated with Optune plus temozolomide versus 14.4 months for patients treated with temozolomide alone, p<.001), and pain (13.4 months for patients treated with Optune plus temozolomide versus 12.1 months for patients treated with temozolomide alone, p<.001).
- Longitudinal analyses of health-related quality of life over time did not significantly differ between treatment arms for any of the predefined scales except for itchy skin, which was worse with Optune plus temozolomide versus temozolomide alone, at three, six and nine months (p=.0004).
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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.
For the treatment of recurrent GBM, Optune 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.
Patients should only use Optune under the supervision of a physician properly trained in use of the device. Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301.
Important Safety Information
Contraindications: Do not use Optune if you have 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 if you 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: Use Optune only after receiving training from qualified personnel, such as your doctor, a nurse, or other medical personnel who have completed a training course given by
Do not use Optune if you are pregnant, you think you might be pregnant or are trying to get pregnant. It is not known if Optune is safe or effective in these populations.
The most common (≥10%) adverse events involving Optune in combination with temozolomide were low blood platelet count, nausea, constipation, vomiting, fatigue, scalp irritation from device use, headache, convulsions, and depression.
The most common (≥10%) adverse events seen when using Optune alone were scalp irritation from device use and headache.
The following adverse reactions were considered related to Optune when using the device alone: scalp irritation from device use, headache, malaise, muscle twitching, fall and skin ulcer.
All servicing procedures must be performed by qualified and trained personnel.
Do not use any parts that do not come with the Optune Treatment Kit, or that were not sent to you by the device manufacturer or given to you by your doctor.
Do not wet the device or transducer arrays.
If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune treatment.
Please see http://www.optune.com/safety to see the Optune Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions.
Patients should only use Optune under the supervision of a physician properly trained in use of the device.
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Ashley Cordova, 212-767-7558