AYA Clinical Trial Successfully Treats Leukemia

Jessica Senn, a former college soccer player, was playing in a recreational indoor league in Brookfield, Wis., in 2011 when she began feeling overly tired and achy.

“I was in reasonably good shape and worked out regularly but was feeling fatigued after only a little bit of running,” she said. Friends thought she might be anemic and convinced her to see her doctor. She made a primary care appointment and had blood tests the Wednesday before Thanksgiving. On Friday, she received a call from her doctor, who said she needed to come back in to see a hematologist right away.

“When my doctor said I could not wait, that’s when I knew it was more serious,” Jessica said. “They told me that I needed to go to Froedtert Hospital.” Jessica had more blood tests, a bone marrow biopsy and spinal tap that revealed she had acute lymphoblastic leukemia (ALL), a type of cancer in which immature white blood cells called lymphoblasts are overproduced in the bone marrow and inhibit normal cell production. These abnormal cells continuously multiply and spread to other parts of the body. Untreated, ALL can be fatal within months. Jessica began treatment on Nov. 27 under the care of Ehab L. Atallah, MD, who specializes in leukemia. Dr. Atallah enrolled then 29-year-old Jessica in a four-phase chemotherapy national clinical trial (CALGB 10403) designed to treat patients from 20 to 40 years old with a chemotherapy regimen more commonly used in children. The trial was the only clinical trial at the time for Jessica’s cancer for her age group, called AYA for “adolescent and young adult.” The study lasted from 2007-2012 and included 318 patients nationwide, nine of whom were treated at Froedtert Hospital.

“When doctors treat patients with ALL, we use different protocols and doses for chemotherapy for adults and children because older patients typically cannot tolerate as much as children,” Dr. Atallah said. “The interesting population is that 20-40 age group.” Typically, AYA patients are treated using the same dosages and protocols as older adults, but Dr. Atallah said that might not be the best approach.

“The trial called for a higher number of chemotherapy treatments per patient, meaning that their total dose was higher than what was typically given. It was more intense, but a theory is that before, doctors were undertreating this age group. We think these AYA patients are young and strong enough to handle more.”

Jessica agreed to participate in the trial, and the first “induction” phase was intense enough that she would need to be admitted to Froedtert Hospital for a month.

“For the first phase of treatment, I was in the hospital until Dec. 19 for chemotherapy, had spinal cord intrathecal chemotherapy, and got fluids. The first day I received my diagnosis, I cried a lot. But I had phenomenal care. During my time in the hospital, I felt like my nurses understood me and got to know me beyond just a person with leukemia. They would ask me one-on-one how I was really feeling. They were around my age, and it felt like they were buddies, which is really important when you’re in the hospital for a month,” she said.

One of the important factors for treating an AYA patient is support from an entire team including physician assistants, a highly qualified nursing staff, research coordinators, a pharmaceutical staff and others, Dr. Atallah said.

Jessica, her husband, Bill, and a friend at the Scenic Shore 150 Bike Tour.

“Their social support and their needs are very different from a pediatric patient,” he said. “Many of them are working and are balancing that with coming in for treatments. They may want to have kids someday, or go to school, or buy a house; they have their whole lives ahead of them. These patients require support in things like fertility counseling, sex counseling, dental services and long-term health management because they are living longer and have unique needs. We really think the AYA population has as many unique characteristics as a pediatric or geriatric population. It takes a village to treat these patients. This is not a regimen that is easy anywhere; it is complicated and intense. So if it is done, it really has to be at an academic medical center.”

Through that summer, Jessica had to come in frequently as part of the trial to have outpatient intravenous chemotherapy two to three days per week for the chemotherapy, lab tests and an anti-cancer chemotherapy drug, PEG-asparaginase. By August, she had treatment once per week and her visits to Dr. Atallah and nurse Kim Johnston dropped to once per month as she went back to her job as a high school Spanish teacher.

“They are like a team, they work together very well. They made me feel like I was the only patient they had,” Jessica said. “Dr. Atallah is a jokester. He is really professional but during my visits he made me feel like I wasn’t just going to see my doctor; I was going to see a friend,” she said.

Another relief for Jessica was that because of her trial treatment, she was spared having to have a bone marrow transplant, which would otherwise have been standard practice.

“Now that we have this trial, we actually don’t recommend transplant to AYA patients because they are strong enough to withstand the higher dosage of chemotherapy instead,” Dr. Atallah said. 

In April 2012, Jessica had the last of her chemo treatment. Now, she is in the “maintenance phase” of her treatment. She sees Dr. Atallah only once every three months for check-ins. As of today, 65 percent of patients treated with this regimen are alive and free of disease, although doctors still don’t know why the treatment works for specific patients. Dr. Atallah now commonly treats AYA patients with this regimen.

“We learned that this regimen seems to be the best for this age group of patients. We will continue to see these patients and monitor and report the outcomes, but we have seen a 78 percent two-year survival rate, whereas without treatment it is only 50 percent,” Dr. Atallah said. “The only way we can advance medical knowledge is to do large studies like this and participate in trials. ALL is, by definition, a rare disease. There are only 6,000 cases per year, 3,000 of which the patient is older than 16. The number who fall in that 20-40 age group is even less, so it is important to study these cases to improve their outcomes.”

Today, Dr. Atallah, John Charlson, MD, and others are leading efforts at the Clinical Cancer Center at Froedtert Hospital to establish a specialized AYA program. The program would ensure that young adult cancer patients have access to state-of-the-art treatments and supportive care.

“The progress that has happened in pediatric ALL treatment is phenomenal, and we are dedicating a lot of time and energy to learn these regimens and protocols to improve outcomes in young adults,” Dr. Atallah said. He also said that they are trying to establish more communication and cooperation between pediatric oncologists and adult oncologists in order to share knowledge and treatments.

Jessica’s life has changed dramatically since she first received her diagnosis. In May 2012, two months after she had been declared cancer-free, her then-boyfriend, Bill, proposed. They were married in 2013 and have a new addition to their growing family. 

“We just had a baby, which is awesome, because sometimes chemotherapy can make conceiving more difficult. But we stayed really positive. We just try not to even think about the negatives.” She said it was the support system that she had in friends, family and her care team who helped her through the experience. “I had a big support system, in friends and family; people like my parents' friends at church did so much for me, along with friends, the soccer team I coached, and all the students and staff at the school. The students designed T-shirts to show support and sent cards and e-mails. There are so many people to thank from that time,” she said. She also found a support system in the Wisconsin Leukemia and Lymphoma Society and participated with her cousin in the Scenic Shore 150 Bike Tour. 

“My support system at Froedtert was incredible. There were the treatments and the diagnosis but it was way more than that. There was an emotional connection I had there.”

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