Real-World Patient-Reported Symptomatic Adverse Events and Concordance With Physician Assessments After Car T-Cell Therapy in Patients With Aggressive B-Cell Lymphomas: A Prospective Study

A recent study published in The Lancet Haematology has demonstrated that patients with aggressive B-cell lymphomas experience a substantial burden of symptoms shortly after CAR T-cell infusion, which is often not fully captured by physician assessments. This work was undertaken by researchers from the Italian Group for Adult Hematologic Diseases (GIMEMA) and 13 CAR T-cell centres across Italy and emphasizes the value of incorporating patient-reported outcomes into post-treatment monitoring.

CAR T-cell toxicity reporting has traditionally focused on cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, while symptoms such as fatigue, appetite loss, pain, insomnia, and emotional distress have remained understudied, prompting the investigators to conduct a prospective, observational multicenter study of 170 adults with diffuse large B-cell lymphoma, mantle cell lymphoma, or primary mediastinal large B-cell lymphoma receiving axicabtagene ciloleucel, tisagenlecleucel, or brexucabtagene autoleucel. At approximately day 10 after infusion, patients completed 19 symptom items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Event (PRO-CTCAE), while treating haematologists independently graded corresponding events using standard CTCAE criteria. The team also calculated an overall symptom-burden score and examined whether baseline clinical characteristics or patient-reported physical functioning predicted early toxicity.

Of the 165 patients alive at day 10, 143 completed the symptom assessment. Twelve of 19 symptoms affected more than half of respondents, led by fatigue (87%), decreased appetite (83%), insomnia (79%), chills (73%), and diarrhea (70%). Moderate-to-severe fatigue, appetite loss, diarrhoea, chills, and insomnia were reported by 55%, 53%, 45%, 35%, and 31% of patients, respectively. Physicians frequently underestimated patients’ experiences, including decreased appetite in 77%, diarrhea in 71%, nausea in 70%, dizziness in 89%, and fatigue in 43% of affected patients; agreement was only fair to moderate. Women reported more moderate-to-severe fatigue than men (74% vs 47%; p=0.0025), while symptom burden was broadly similar across age groups and CAR T-cell products. In multivariable analysis, male sex (β −3.08; p=0.048) and better baseline physical functioning (β −1.10 per 10-point increase; p=0.0091) predicted lower burden. Therefore, the authors suggest that systematic patient-reported monitoring could improve early supportive care and identify patients most likely to struggle after CAR T-cell therapy.

Reference:

Efficace F, Zinzani PL, Bonifazi F, et al. Real-world patient-reported symptomatic adverse events and concordance with physician assessments after CAR T-cell therapy in patients with aggressive B-cell lymphomas: a prospective study. Lancet Haematol. 2026;13(7):e460-e470. https:/doi.org/10.1016/S2352-3026(26)00128-6