A new study published in Blood Advances indicates that CAR-T therapy can be safely and effectively administered in an outpatient setting for patients with relapsed or refractory large B-cell lymphoma (LBCL). The multi-center OUTREACH trial demonstrates the feasibility of providing this advanced cancer treatment in community hospitals, potentially expanding access for patients who may not be able to travel to specialized university centers.
The study, led by Dr. Yuliya Linhares from the Miami Cancer Institute, involved 82 patients with LBCL who had previously failed two or more lines of treatment. Participants were eligible to receive lisocabtagene maraleucel (Breyanzi), a CAR-T cell therapy known for its relatively lower risk of serious side effects. The primary goal was to assess the practicality of outpatient administration and its impact on patient outcomes.
Key Findings from the OUTREACH Trial
The results showed that 70% of patients received CAR-T therapy on an outpatient basis. Among these, 25% did not require any hospitalization during the treatment period. For those who were hospitalized, the median length of stay was six days, significantly shorter than the 15-day median stay for patients treated as inpatients.
Efficacy outcomes were consistent with previous lisocabtagene maraleucel trials, with an 80% objective response rate and a 54% complete response rate. These results indicate that outpatient administration did not compromise the effectiveness of the therapy.
Safety Profile and Adverse Events
Approximately half of the participants experienced mild cytokine release syndrome (CRS), a common side effect of CAR-T therapy characterized by flu-like symptoms. However, no patients experienced CRS of grade three or higher. Rates of neurotoxicity and infections were also low and comparable to those observed in earlier trials, suggesting that outpatient treatment did not increase the risk of adverse events.
Expanding Access to CAR-T Therapy
"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 Dr. Linhares. The OUTREACH study demonstrates that community hospitals can successfully implement CAR-T cell programs with appropriate training and protocols, potentially reducing wait times and improving patient outcomes.
The study's authors emphasize the importance of well-defined standard operating procedures, multidisciplinary team coordination, and comprehensive staff training to ensure the safe and effective delivery of outpatient CAR-T therapy. Further research is needed to identify which patients are most suitable for outpatient versus inpatient treatment.
Implications for Future Treatment
The findings suggest a paradigm shift in how CAR-T therapy is administered, potentially making it more accessible to a broader range of patients. By demonstrating the feasibility and safety of outpatient treatment in community settings, the OUTREACH study paves the way for wider adoption of this life-saving therapy.
The study was funded by Bristol Myers Squibb, the manufacturer of lisocabtagene maraleucel.
