Patient-reported symptomatic AEs following CAR T-cell therapy in aggressive B-cell lymphomas

Results from a real-world, prospective, observational, multicenter study (NCT06026644) from the Gruppo Italiano Malattie Ematologiche dell’Adulto (GIMEMA), investigating short-term patient-reported symptomatic adverse events (AEs) in 170 patients with aggressive B-cell lymphomas (diffuse large B-cell lymphoma, n = 118; mantle cell lymphoma, n = 32; primary mediastinal large B-cell lymphoma, n = 20) receiving chimeric antigen receptor (CAR) T-cell therapy (axicabtagene ciloleucel, n = 98; tisagenlecleucel, n = 39; or brexucabtagene autoleucel, n = 32), were published in The Lancet Haematology by Efficace et al. The primary objective of this analysis was to assess the prevalence of short-term patient-reported symptomatic AEs at Day 10 post-infusion via the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

Key data: At Day 10 post-infusion, a prevalence of more than 50% was observed across 12 of 19 symptomatic AEs of any grade, assessed using the PRO-CTCAE; fatigue (87%), decreased appetite (83%), and insomnia (79%) were the most common general, gastrointestinal (GI), and neuropsychiatric events reported by patients. The most common moderate-to-severe grade AEs were fatigue (55%), decreased appetite (53%), diarrhea (45%), chills (35%), and insomnia (31%). Physicians frequently underreported symptoms in their patients, most commonly hair loss (91%), dizziness (89%), swelling (83%), discouragement (82%), difficulty swallowing (78%), and decreased appetite (77%). In multivariable analysis, male sex (β –3.08; 95% confidence interval [CI], –6.13, –0.03; p = 0.048) and higher baseline physical functioning scores (β –1.10; 95% CI, –1.90, –0.30; p = 0.0091) were independently associated with lower symptom burden.

Key learning: A substantial early symptom burden following CAR T-cell therapy was observed, which is incompletely captured by physician assessment alone, supporting routine integration of patient-reported outcome (PRO) measures to improve supportive care and patient counseling.