After participating in a groundbreaking clinical trial that showed the Optune tumor treatment field device improves glioblastoma multiforme survival when combined with chemotherapy, neuro-oncologists at the Norton Healthcare Brain Tumor Center in Louisville, Kentucky, are treating non-trial participants.

Approval by the Food and Drug Administration (FDA) of the device in conjunction with maintenance temozolomide chemotherapy for newly diagnosed glioblastoma patients provides one of the few new glioblastoma treatments in years. Glioblastoma is the most common and aggressive primary brain tumor with patients often surviving less than 18 months.

The trial compared patients treated with temozolomide and the Optune device versus temozolomide alone. The study found that the combination of Optune and chemotherapy produced a significant improvement in survivability.

Results of the study, published in JAMA: The Journal of the American Medical Association, found 13% of patients who were treated with Optune and chemotherapy survived five years, compared with 5% of patients who received chemotherapy but not the Optune treatments.

The principal investigator for the trial at the Norton Healthcare Brain Tumor Center — the only trial site in Louisville or Southern Indiana — was Renato V. LaRocca, M.D., neuro-oncologist and cancer medicine specialist.

Researchers at the Norton Healthcare Brain Tumor Center, a collaboration of Norton Neuroscience Institute and Norton Cancer Institute, have started a clinical trial to examine the device’s benefits when combined with radiation therapy and chemotherapy. Dr. LaRocca is the principal investigator on the trial which is actively accruing patients.

How the Optune device works

The Optune is a portable device worn on the shaven head. It continuously delivers tumor treatment fields directly to the area of the tumor, ideally for 18 or more hours per day. The electrical tumor treatment fields disrupt cancer cell division, and may destroy them, without affecting healthy tissue.

Optune is approved by the FDA to treat glioblastoma in patients ages 22 or older. Newly diagnosed patients may be treated with Optune in combination with chemotherapy once a surgeon has removed as much of the tumor as possible. Previously, Optune was available only to patients with glioblastoma that had been resistant to all other treatments.

Leading treatment for glioblastoma and addressing Optune side effects

Since adopting the Optune with its initial approval in 2015, the Norton Healthcare Brain Tumor Center’s neuro-oncologists are some of most experienced with the device and have a smooth process for getting patients started on their treatments.

One of the most few side effects of Optune is skin irritation that can range from an itchy scalp to, more rarely, ulcers and infections. Skin irritation can interfere with the device’s greatest benefit coming from long-term daily use.

Dr. LaRocca co-authored a study published in Frontiers in Oncology that found specific skin-care efforts and shifting the array of transducers about three-quarters of an inch during changes could mitigate irritation. The study, “Prevention and Management of Dermatologic Adverse Events Associated With Tumor Treating Fields in Patients With Glioblastoma,” recommends antibiotics, skin barrier films, moisturizers, topical corticosteroids and antiperspirants, depending on the diagnosis and its severity.