Navy Vet is Armed with a Wearable Device during Battle against Cancer

(BPT) - When Navy vet Terry O’Keefe first started to get sick, he was enjoying his retirement, touring the U.S. in an R.V. with his wife, Diane.

At first, the couple thought that Terry just had allergies, but as Terry’s condition became steadily worse as they drove from state to state, Diane became worried.

“Finally, Diane said, ‘You are going to the hospital and that’s it.’”

The couple would soon learn that Terry had malignant pleural mesothelioma (MPM), a rare but severe form of cancer that affects the linings of the lungs.

Terry’s problems with MPM likely started decades before, during his time with the U.S. Navy in the 1970s. Here, while working in his ship’s boiler room, he had close contact with asbestos.

“It was everywhere. Everything had asbestos on it, in it, around it,” Terry recalled from his home in Pennsylvania. “The dust in the boiler room was like snow — we’d make snowballs and throw it at each other. We were a bunch of dumb kids; we didn’t know.”

Asbestos is now known to be the leading cause of MPM. However, symptoms often don’t appear until decades after exposure, which, along with non-specific symptoms, can often lead to delayed diagnosis.

Armed with a diagnosis, Terry next sought treatment, wanting to be ‘as aggressive as I could be.’ Zachary D. Horne, MD, a radiation oncologist at Alleghany Health Network Cancer Institute, recommended a treatment that was approved by the FDA in May 2019 — a wearable device called Optune Lua^TM.

“I said, ‘Yes, I’ve got stuff we’re trying to do,’” Terry recalled saying to Dr. Horne. “I’m not ready to give up.”

Optune Lua is a wearable, portable, FDA-approved device developed by Novocure, a global oncology company, and was the first FDA-approved treatment for mesothelioma in 15 years.

According to Horne, “The treatment is non-invasive and delivers treatment directly to the tumor, and most patients experience only minor side effects.”

Optune Lua works by delivering low-intensity, wave-like electric fields via adhesive patches called transducer arrays, placed on a patient’s upper body. These fields, known as Tumor Treating Fields or TTFields are not strong enough to hurt a patient or his or her healthy cells, but are strong enough to slow or stop cancer cells from dividing and may destroy some cancer cells completely. Optune Lua is used together with standard chemotherapy. When used with chemotherapy, skin irritation was the most common side effect.

“Because the electric fields are tuned very specifically to a cell size, they impact the mesothelioma cells, and they leave everything else essentially alone,” Dr. Horne said.

According to Dr. Horne, the more the device is used, the more effective it is.

“When I met Terry I thought to myself, ‘We need to give him the best chance while managing the disease the best we can,’” said Dr. Horne. “The goal with Optune Lua is to slow or stop disease progression for as long as possible.”

Terry and Diane both worked with Dr. Horne and the nCompass team at Novocure, which offers the patient customized support based on their needs. This includes everything from working with a patient’s insurance provider to minimize costs, offering travel assistance and resources, troubleshooting any technical issues 24/7 via phone and more.

“They have helped me with our insurance company, everything,” Diane said.

Part of the nCompass team is a Device Support Specialist (DSS), who not only provides the initial training around using Optune Lua but also conducts monthly check-ins to review treatment usage and offer any tips and resources.

According to Diane, “If we have any questions or anything, she helps us right out.”

While there is an initial adjustment to using the device, Dr. Horne recognizes that it can be a worthwhile treatment for those fighting mesothelioma.

“We look forward to providing Optune Lua as a treatment option for additional patients who may otherwise feel that they have little hope for the future,” Dr. Horne said.

For Terry and Diane, right now they are enjoying their present by hiking, kayaking and going out on nature walks with two dogs. Based on advice from Dr. Horne, Terry is able to wear Optune Lua for all his activities except kayaking.

Terry, whose oldest son tragically died of cancer at the age of 25, hopes that sharing his experiences living with mesothelioma may serve as a motivation to others.

“I have already lived longer than what doctors predicted when I was first diagnosed,” he said. “And I’ve come to the conclusion that my mission in life is to help the next generation ... because I’d like to see this — and all these cancers — find a cure.”

Optune Lua for MPM is classified as a Humanitarian Use Device (HUD), approved under the Humanitarian Device Exemption (HDE).

Caution: Federal law restricts this device to sale by or on the order of a physician. Humanitarian Device. Authorized by Federal Law for use in the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma concurrently with pemetrexed and platinum-based chemotherapy. The effectiveness of this device for this use has not been demonstrated.

What is Optune Lua™ approved to treat?

Optune Lua is a wearable, portable, FDA-approved device indicated for the treatment of adult patients, with unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM) to be used together with standard chemotherapy (pemetrexed and platinum-based chemotherapy).

Who should not use Optune Lua?

Optune Lua is not for everyone. Talk to your doctor if you have:

• An implanted electronic medical device including a pacemaker, implantable automatic defibrillator, etc. Optune Lua has not been tested in people with implanted electronic devices, which may cause the devices not to work properly
• A known sensitivity to conductive hydrogels (the gel on the arrays placed on the upper body like the ones used on EKGs). When Optune Lua comes into contact with the skin, it may cause more redness and itching or may rarely cause a life-threatening allergic reaction

Do not use Optune Lua if you are pregnant or are planning to become pregnant. It is not known if Optune Lua is safe or effective during pregnancy.

What should I know before using Optune Lua?

Optune Lua should only be used after receiving training from qualified personnel, such as your doctor, a nurse, or other medical staff who have completed a training course given by Novocure^®, the maker of Optune Lua.

• Do not use any parts that did not come with Optune Lua sent to you by Novocure or given to you by your doctor
• Do not get the device or transducer arrays wet
• Please be aware that Optune Lua has a cord that may cause tripping when connected to an electric socket
• If you have an underlying serious skin condition on the upper body, discuss with your doctor whether this may prevent or temporarily interfere with the Optune Lua treatment

What are the possible side effects of Optune Lua?

Most common side effects of Optune Lua when used together with chemotherapy were low red blood cell count, constipation, nausea, tiredness, chest pain, fatigue, skin irritation from device use, itchy skin, and cough.

Other potential adverse effects associated with the use of Optune Lua include: treatment related skin irritation, allergic reaction to the plaster or to the gel, electrode overheating leading to pain and/or local skin burns, infections at sites of electrode contact with the skin, local warmth and tingling sensation beneath the electrodes, muscle twitching, medical device site reaction and skin breakdown/skin ulcer.

Talk to your doctor if you have any of these side effects or questions.

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

© 2020 Novocure GmbH. All rights reserved. Novocure and Optune Lua are trademarks of Novocure GmbH. US-OPT-04167. December 2020