Patients with a fast-spreading blood cancer respond well to outpatient treatment with CAR-T therapy, the largest study examining its use in a community setting has found.
CAR-T is shorthand for chimeric antigen receptor therapy. In this treatment, doctors remove the patient's own white blood cells, tweak them in a lab and then infuse them back into the patient to attack and kill cancer cells.
The new study included 82 patients whose large B-cell lymphoma had failed to respond to treatment or had returned after a period of remission. CAR-T can be an effective treatment option in these cases, but pursuing the therapy can be challenging.
"Traditionally, CAR-T cells have been administered by expert teams at university-based medical centers, which of course limits access to this very-needed therapy," said lead researcher Dr. Yuliya Linhares, chief of lymphoma services at the Miami Cancer Institute. "The longer patients have to wait for CAR-T administration, the worse the outcomes."
Researchers said patients and caregivers must often travel to centers far from home for CAR-T treatment and secure temporary housing. Because they must be closely monitored, they are advised to stay within one hour of the treatment center.
The new study, dubbed OUTREACH, looked at the feasibility of administering CAR-T therapy on an outpatient basis.
Large B-cell lymphoma is a cancer affecting a type of white blood cell known as B lymphocytes. It can spread quickly and is fatal if not treated. Most forms of the cancer respond well to standard treatments.
Because all of the participants in this study had already received two or more prior lines of treatment, they were eligible to receive lisocabtagene maraleucel (Breyanzi), one of two approved CAR-T cell products. Researchers chose it because it has a relatively low risk of serious side effects.
Nearly three-quarters of medical centers that took part in the study had never treated patients with CAR-T therapy.
Ultimately, 70% of study participants received the therapy on an outpatient basis. Of those, a quarter were never hospitalized. Of those who did go to the hospital, six days was the median stay for those treated on an outpatient basis, meaning half had shorter stays, half had longer ones. Those who received CAR-T cells as inpatients had a 15-day stay.
Roughly half of participants had a mild reaction to treatment called cytokine release syndrome. Symptoms are similar to those of flu. Rates of neurotoxicity events — which range in severity from mild confusion to seizures and hallucinations — were low. Researchers said they were in line with those seen in other trials.
They added that this indicated that patients faced no increased risk whether they received outpatient treatment or treatment in a community hospital setting.
The findings were published Sept. 30 in Blood Advances, a journal of the American Society of Hematology.
"I encourage as many sites as possible to work on building CAR-T cell programs," Linhares said in a journal news release. She added that well-outlined protocols and extensive staff training are essential to ensure that any complications are spotted and addressed quickly.
She said more research could help define which patients are best suited for outpatient care versus inpatient treatment.
The study was funded by Bristol Myers Squibb, maker of Breyanzi.