Rural Americans have difficulty accessing a promising cancer treatment

Suzanne Behana initially refused an experimental but potentially life-saving cancer treatment.

Three years ago, the newlyweds, then 62, were sick with stage 4 lymphoma, sick from two failed rounds of chemotherapy and sick of living in a trailer park near the University of Texas MD Anderson Cancer Center in Houston. It’s the fall of 2019, and treatment has forced her to move 750 miles east from rural New Mexico, where she’d settled just a few months before her diagnosis.

Chimeric antigen receptor T-cell therapy might have appealed to Behanna if it had been available closer to home. But it is offered only in major transplant hospitals.

Behanna had been living in Houston for six months, suffering through chemotherapy that made her feel horrible and didn’t stop her cancer. She wanted to go home to die, but her husband wanted her to have a chance at CAR T-cell therapy if her doctor approved it.

The therapy uses the patient’s T cells, a key part of the immune system, to fight the cancer. Dr. Michelle Sadeline, an immunologist at Memorial Sloan Kettering Cancer Center in New York and a pioneer of the therapy, describes it as “a living medicine — a T cell weaponized against cancer.”

The treatment uses a process called apheresis to extract T cells from the patient and then genetically alter the cells to add a receptor, a chimeric antigen, that binds to cancer cells.

It takes about 10 days to make CAR T cells, but because only three companies — Bristol Myers Squibb, Gilead Sciences, and Novartis — have FDA approval to produce them commercially, it can take up to a month to get the cells back for infusion. Once in the patient’s bloodstream, CAR T cells multiply, recognize cancer cells, and kill them. If the therapy works, the patient’s cancer usually goes into remission within a month.

For nearly 10 years, oncologists have used CAR T-cell therapy in clinical trials for patients with blood cancers — including Behanna, who has diffuse large B-cell lymphoma, and others with lymphoblastic leukemia and multiple myeloma. But until recently, it was only FDA-approved for people who had already had two unsuccessful rounds of more conventional treatments like chemotherapy. For some types of blood cancer, therapy leads to remission in more than half of patients. In April, for the first time, the FDA approved CAR T-cell therapy for lymphoma patients whose cancer recurred within 12 months after only one round of more conventional treatment.

That more people will be eligible for CAR T-cell therapy seems like good news, but Dr. Jason Westin, an oncologist at MD Anderson, isn’t immediately optimistic. Westin, chairman of the American Society of Clinical Oncology’s government relations committee, worries that as more patients become eligible, the cost — $375,000 to $475,000 — will strain insurers’ ability to support it.

Patients who meet the FDA’s threshold for treatment are a relatively small group. “If it’s a tiny, tiny fraction of patients getting an expensive treatment, it’s hard on the system but not a break point,” Westin said. “But if you increase that slice of the pie for patients, it starts to put more pressure on limited resources.”

Insurance carriers, including Medicare, pay for CAR T-cell therapy, although they typically don’t cover living expenses for patients who have to stay away from home, often for months, according to the Leukemia and Lymphoma Society. Blue Cross Blue Shield covered Behanna’s medical expenses but reimbursed her only $5,000 for living expenses, a small fraction of what she and her husband spent living in Houston.

And new research into using the technology to treat other cancers, autoimmune disorders and even infections could put pressure on already constrained supply chains.

There are other, less expensive, ways to make CAR T cells besides going to a big pharmaceutical company Many researchers working on clinical trials, including Dr. Michael Chu of the Cross Cancer Institute in Edmonton, Alberta, use a breadmaker-sized bioreactor made by Milteny Biotech to modify T cells in the lab. Some medical centers have established in-house T-cell production platforms that use other bioreactors and protocols.

But the FDA hasn’t authorized medical centers and academic institutions to make the cells for commercial use, and neither Sadeline nor Westin expects that to happen anytime soon.

Cost is not the only drawback to CAR T-cell therapy. Side effects can be life-threatening — about 2% of patients die from the treatment, according to Chu.

The most common side effect is a cytokine storm. Cytokines are small proteins that help regulate the immune system, and their presence means the immune system is working. But sometimes the treatments send the immune system into overdrive, with results ranging from nausea and fever to organ failure.

Potential toxic reactions to treatment have indicated where it can be administered. “If someone gets bad side effects, they need to be in a place that can manage and set them up,” Westin said. “A place that’s used to giving breast-cancer or lung-cancer treatment — they’re not experiencing how to handle potentially life-threatening side effects.”

Because of that, the treatment is available at about 150 transplant centers, where specialists are available to oversee care, Westin said.

This creates accessibility issues for nearly half of American adults who live at least half an hour from the nearest transplant center. “These patients have been through a lot,” Chu said. “Asking them to go a little further, in some cases that’s a step too far, either on a psychological front, on a financial front or on a social front.”

So it was with Behanna. He did not want to participate in another clinical trial. But her husband Chris did so much, first to learn about the treatment and then to lobby her doctor. “He promised me if it didn’t work, I could go home, and that was all I cared about,” he said. “I didn’t expect it to work.”

To make sure her T cells were healthy enough to be genetically modified, Behanna had to have more chemo, which meant more time in Houston. About a month passed between apheresis and when the CAR T cells were ready to be infused. “When I got my cells back, I was really, really sick, and I didn’t care if it worked or not,” she said.

For the first few days after the infusion, Behanna felt better. But on the third or fourth day, when asked a routine series of questions that test her neurological function, she was clearly experiencing neurotoxicity — a side effect that reverses itself in most patients. His temperature rose. The cytokine storm began. He was transferred from the CAR T-cell ward to the intensive care unit.

When she woke up a few days later, lucid but weak, she could remember saying “a lot of bad, terrible things” to Chris.

Behanna began to cry as she got her bearings and reached down to touch her stomach as she recounted her first moments in the ICU. “It was clear to me the first time until I remember I could touch my stomach and it wasn’t hard,” she said. “I could feel the tumor going away.”

Before her treatment in October 2019, a scan showed tumors all over her body: in her armpits, chest, abdomen and groin. In late November, around Thanksgiving, Behanna had another scan.

“I didn’t have a tumor,” she said. “It was surreal.”

Behanna is grateful to be alive but frustrated that patients must go through multiple rounds of grueling chemotherapy before being allowed to proceed with the treatment that can so effectively eradicate their cancer.

“CAR-T is a little rough,” she said, but “it wasn’t hard for me because I don’t remember any of it. It was something I was willing to risk because you either do CAR-T or you go home and die. .”

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