A study led by Baptist Health Miami Cancer Institute supports emerging scientific evidence that complex immunotherapy treatment can be safely provided on an outpatient basis instead of requiring a hospital stay — at specialized, community-based centers.

Key to the change in the long-standing practice of delivering the care on an inpatient basis at tertiary academic medical centers is ensuring that there is a skilled multidisciplinary team present. Additionally, training patients and caregivers to recognize early signs of complications is crucial.

OUTREACH, A Safety Trial of Lisocabtagene Maraleucel (liso-cel) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma in the Outpatient Setting was led by Yuliya Linhares, M.D., chief of Lymphoma at the Institute. She has presented a primary study analysis in the peer reviewed medical journal Blood Advances and on VuMedi, a video education platform for physicians.

“OUTREACH is, to our knowledge, the first and largest prospective clinical trial of its kind,” Dr. Linhares says. “For appropriate patients, liso-cel is safe and feasible when delivered on an outpatient basis by a highly trained team.”

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.

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 (CRS). Life-threatening symptoms can include fever, headache, nausea and vomiting, difficulty breathing, low blood pressure and a fast heart rate. Outpatients were required to have caregiver support and stay within one hour of the study site for 30 days after liso-cell infusion.

The study included 82 patients at 18 sites across the U.S. Of those, 70 percent were monitored as outpatients and 30 percent were treated as inpatients. Findings included:

• No Grade ?3 CRS in outpatients or inpatients
• CR rates were 58 percent in the outpatient group and 44 percent in the inpatient cohort
• 33 percent of outpatients and 32 percent of inpatients experienced prolonged cytopenia, which was the most common complication
• The median progression-free survival was six months in outpatients and four months in inpatients
• After infusion, 25 percent of outpatients were never hospitalized and few outpatients or inpatients required admission to the intensive care unit
• The median initial hospitalization duration after liso-cel was 6.0 days (range 1-28) for outpatients and 15.0 days (range 3-31) for inpatients

“Baseline characteristics were generally similar for outpatients and inpatients,” she says in the VuMedi presentation. “Inpatient monitoring was at the investigator’s discretion and was most commonly due to disease characteristics, including tumor burden, risk of adverse events or psychosocial factors such as lack of caregiver support or transportation.”

Delivering sophisticated care through outpatient services at local community medical centers improves patient access to treatment, she adds. 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.