Breakthrough in Safe Outpatient Treatments for Lymphoma

A study led by Baptist Health Miami Cancer Institute demonstrates that a complex cancer therapy can be given to patients on an outpatient basis instead of requiring a hospital stay — and it can be done safely at a community-based hospital, rather than an academic medical center.

Key to the breakthrough is ensuring that there is a skilled multidisciplinary team at the community-based hospital capable of providing the cutting-edge care. Baptist Health Foundation donors provided philanthropic support for patient lab expenses and treatment-related infusions within the trial.

Study Led by Baptist Health Miami Cancer Institute

The OUTREACH study focused on giving lisocabtagene maraleucel (liso-cel) to patients with relapsed or refractory B-cell non-Hodgkin lymphoma. These are patients whose blood cancer has come back or hasn’t responded well to other treatments.

While lymphoma survival rates have significantly improved in recent years, some 30 to 50 percent of patients with B-cell non-Hodgkin lymphoma eventually relapse, making effective outpatient treatment options particularly important.

“OUTREACH is, to our knowledge, the first and largest prospective clinical trial of its kind,” says Yuliya Linhares, M.D., chief of Lymphoma at Miami Cancer Institute. “For appropriate patients, liso-cel is safe and feasible when delivered on an outpatient basis by a highly trained team.” Dr. Linhares, who led the study, has presented early results in medical journals and on physician education sites.

Using the Patient’s Own Immune System

The study included 82 patients — 70 percent outpatient and 30 percent inpatient. Liso-cel is a type of CAR T-cell therapy that involves using a patient’s own immune cells to fight cancer. During treatment, doctors remove T-cells from the patient’s blood and modify them in the lab to better recognize cancer cells. The modified cells are put back into the patient, where they can attack the cancer more effectively.

The procedure requires close monitoring because one of the serious side effects of CAR T-cell treatments is cytokine release syndrome. It occurs when immune cells in the body release large amounts of chemicals into the blood. Life-threatening symptoms can include fever, headache, nausea and vomiting, difficulty breathing, low blood pressure and a fast heart rate.

Keeping Patients Out of the Hospital      

“Outpatients and caregivers were educated to recognize early signs of cytokine release syndrome and neurological events as well,” Dr. Linhares says. “Cytokine release rates were high in the total population and similar in both outpatients and inpatients.”

During the study, few outpatients or inpatients required admission to the intensive care unit and 25 percent of outpatients were never hospitalized after liso-cel infusion, she adds. Delivering advanced medical care through outpatient services at local community centers improves patient access to treatment. Additionally, the financial burden on patients and the healthcare system is generally lower in the outpatient setting.

Dr. Linhares believes that new technologies, techniques and medications are helping prolong remission and overcome resistance mechanisms as care for blood cancers continues to evolve.

Yuliya Linhares, M.D., chief of Lymphoma at Baptist Health Miami Cancer Institute