Close Monitoring, Full-Time Caregiver Recommended for 30 Days After CAR-T Therapy

Patients with diffuse large B-cell lymphoma (DLBCL) undergoing treatment with axicabtagene ciloleucel (axi-cel) should be closely monitored for at least a month after discharge from initial planned hospitalization. These findings were presented during the ASCO20 Virtual Scientific Program.

Axi-cel is a CD19-targeted chimeric antigen receptor T-cell (CAR-T) therapy approved by the US Food and Drug Administration for the treatment of DLBCL after 2 lines of treatment. Patients undergoing CAR-T therapy with axi-cel are monitored in the inpatient setting for a minimum of 7 days after CAR-T infusion; however, risk of complications that can lead to readmission is high. Researchers conducted a retrospective study to assess the rate and etiology of readmissions after initial discharge.

For the study, readmission was defined as an inpatient stay of longer than 48 hours while under the auspice of the immunotherapy service. Cytokine release syndrome (CRS) was graded based on the Lee criteria and neurotoxicity on the CTC v.4 criteria. The association between clinical factors and readmission were studied using logistic regression models.

This study included 44 patients who underwent CAR-T therapy with axi-cel (median age, 62 [range, 25-79], 33 of whom had primary refractory disease and 14 had undergone prior transplant. All patients had received a median of 3 lines (range, 2-9) of treatment before undergoing CAR-T therapy. Leukapheresis was performed at a median of 10 weeks (0.5-109) after the most recent treatment, and 22 patients received bridging therapy between leukapheresis and lymphodepletion. Initial planned admission was for 6 to 16 days (median, 7.5 days).

Six patients (14%) were readmitted after initial hospitalization, with 1 patient having had 2 readmissions. Readmission occurred between day 9 and day 25 (median, day 13). Subsequent hospitalization was for a median 5 days (range, 2-31). Three of the 6 patients were admitted to the intensive care unit during their second hospitalization. No association was observed between pre- and post-CAR-T variables and risk of readmission in multivariable models. Reasons for readmission were infection (2), CRS (2), GI bleed (1), progressive disease (1), and neurotoxicity (1).

“This data supports our current policy of close monitoring until at least a month after CAR-T therapy and supports the requirement of a full-time caregiver until discharge from the immunotherapy service,” the researchers concluded.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original abstract for a full list of disclosures.

Reference

Perkins P, Cearley A, Kirk A, Mullane E, Shadman M, Maloney DG. Assessing readmission after axicabtagene ciloleucel immunotherapy. Presented at: ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(suppl):abstr 3024.