Electrified skull-cap helps keep cancer under control

"I am a husband and the father of two, a girl and a boy, both in college, and I still have my mom," said Enrique Ledesma. "So I will do whatever I can to fight this disease, to prolong my life. Because, who's going to take care of them if I'm not around?"

Ledesma, 53, of Berrien Springs, Michigan, has ample motivation, but he also has glioblastoma (GBM), an aggressive, usually lethal, primary brain tumor. The prognosis for patients with GBM is poor, and progression tends to occur quickly.

His doctors in Michigan, where he was first diagnosed, told him that with GBM, it was not uncommon for the tumor to double in size each month. They predicted he might live a few more months, maybe a year, with luck up to 16 months.

A few lucky patients do better. An estimated five to ten percent are still alive five years after diagnosis. Such cases, unfortunately, are rare. Faced with this disappointing prognosis, Ledesma and his wife searched for something novel, and more promising.

They appear to have found it. Since he began his new regimen, he's had no tumor progression, month after month.

The Ledesmas' battle began more than a year ago, in January, 2015. He developed severe headaches with no apparent cause. A physician assistant in Michigan ordered an MRI scan, which revealed a mass the size of a baseball, a tumor nearly seven centimeters wide, growing in his brain.

He had surgery, in Michigan, the day after the 2015 Super Bowl. The football team his surgeon had been pulling for lost. "This had no effect on his disposition," Ledesma said, but the surgical team could only remove about 60 percent of the tumor. The goal is to take out 95 percent or more.

After the operation, Ledesma went through the standard post-operative protocol of radiation and chemotherapy. Meanwhile, his wife, Janet, a professor at Andrews University-also in Berrien Springs, Michigan-began consulting with medical professionals and conducting her own research into GBM.

 

 

 

 Meanwhile, during one of Enrique's post-op visits, his surgeon mentioned a neuro-oncologist who was doing some interesting work on electrical-pulse therapy for GBM patients. He said he would contact Rimas Lukas, MD, an associate professor of neurology at the University of Chicago. By the time Enrique and his wife got home, Dr. Lukas-fortunately just 66 miles away-had agreed to meet with them the following Tuesday.

Janet continued her own research and quickly found articles about the electrical work, known as tumor-treating fields, an innovative therapy developed specifically for patients with GBM. This was exactly what Lukas had suggested. It relies not on cell-killing drugs or radiation, but on shifting electrical forces to kill glioma cells.

"This sounded interesting and different," she said. She called two physician friends in New York who dug into the project, combing through the literature. Although the procedure is not yet well known, they were favorably impressed. The U.S. Food and Drug Administration approved the Optune device in October, 2015, to treat patients with newly-diagnosed glioblastoma multiforme.

Lukas, who specializes in evaluating new techniques and medications for brain tumor treatment, already had several patients using this treatment approach, developed by a company called Novocure. Their device, marketed as Optune, provides a novel way to treat brain tumors. Instead of using radiation, or drugs, or revving up the immune system, Optune relies on shifting electrical impulses. It was designed to kill dividing cancer cells in the brain. It appears to do this without harming healthy cells.

The Optune system works by sending alternating electrical fields through the brain. These travel in different directions across the upper part of the brain, but are focused on the tumor. The goal is to disrupt the mitotic spindles, tiny fibers that pull chromosomes apart when a cell is preparing to split in two-something that cancer cells do relentlessly. If the spindles fail at their job, the cancer cells self-destruct. Optune patients also take the anti-cancer drug temozolomide, which has mild side effects.

The combination or tumor-treating fields and temozolomide rarely causes significant nausea, malaise, lethargy or difficulty concentrating, hazards associated with many cancer treatments. Instead, it can give patients an itchy, raw, painful scalp.

Optune is delivered through a set of 36 ceramic electrodes, each the size of a quarter, arranged in grids on four transducer arrays. These are strategically positioned, then taped or glued onto the scalp. How the arrays are placed varies with each patient's tumor. Patients are encouraged to wear these arrays at least 18 hours a day, more if they feel up to it.

"The side effects aren't systemic," Lukas said. "They are local, primarily affecting the scalp. It causes low grade ulcerations and can lead to infection in some patients."

"My wife and daughter shave my head every three days," Ledesma explained. "Then they stick these four pads onto my head. We have diagrams of exactly where to place them. Each array has a wire that plugs into a belt pack, which plugs into a backpack, which holds a computer and batteries. I wear it pretty much all the time."

Although he has done this for a few months, "I'm still not used to it," he admits. "Sometimes a wire gets caught on something and my head snaps back. Door knobs are the worst."

"There's one other issue no one prepared us for," he points out. The media run stories almost every day about terrorist activities. "Then here I come, wearing a white hood and a big khaki-colored backpack filled with batteries and wires. When the battery runs low, it starts to beep. This causes strangers stare at me," he said. They get anxious. "I just tell them: Don't worry about my beep. I'm not going to explode. I'm just backing up."

A recent study, published in the Journal of the American Medical Association just before Christmas, 2015, found that the combination of tumor-treating fields with a drug called temozolomide could extend life by about five months, on average, compared to taking the drug alone. Patients who took just the drug lived about 15.6 months, and those who combined the drug with the Optune system lived nearly one-third longer. Alarming a few neighbors may be a small price to pay.

"I've been battling this cancer for more than a year now and I'm pleased to say I'm still here," Ledesma said. "I'm doing OK. I'm mobile. I have my memory. My disease has been stable. I cut my grass and play golf with my children. We even took a trip at Christmas to San Francisco."

"Is it an easy thing?" he asks. "No. It has its challenges. But in the long run, it helps. It means a few extra days or weeks, or even months, with my family. Dr. Lukas got me this far, my family keeps me going, and I'm trusting a lot on my God to intervene. That's all I can ask for."